CAPE TOWN – Johnson & Johnson (J&J) will deliver its COVID-19 vaccine to Africa from October after reaching an agreement with the African Union to supply the continent with up to 400 million doses over the next two years. 

However, Africa may still be struggling to obtain vaccine supplies for some months following last week’s decision by the Serum Institute of India (SII) to scale back its delivery of the AstraZeneca vaccine to the WHO co-sponsored COVAX global vaccine facility – in order to address domestic demand as COVID-19 cases soar in India. 

To date, the AstraZeneca vaccine has been the backbone of the COVAX facility’s ambitious roll-out of vaccines to dozens of low- and middle-income countries. But the SII suspension would interrupt the planned March and April delivery of some 90 more vaccine doses at a time when some countries have already used up their allotted supplies, and another 10 countries in Africa and 20 worldwide have yet to receive any vaccines at all.    

J&J CEO Alex Gorsky

 J&J CEO Alex Gorsky announced the deal with the AU’s “African Vaccine Acquisition Trust (AVAT)” on Monday saying that his company has been “committed to equitable, global access to new COVID-19 vaccines” from the start of the pandemic.

“Our support for the COVAX Facility, combined with supplementary agreements with countries and regions, will help accelerate global progress toward ending the COVID-19 pandemic,” he added.

AVAT can order up to 220-million doses this year and an additional 180 million doses in 2022, according to the company.

Single Dose and Efficacious Against Variant

The J&J vaccine only requires one dose, it can be stored in a normal fridge for up to three months.  It has been tested in diverse populations and it has shown be able prevent death and severe illness – even in the case of the more infectious B.1351 (501Y.V2) variant first identified in South Africa. 

J&J has also committed to providing its vaccine on a not-for-profit basis for emergency use during the pandemic.

The vaccine was granted Emergency Use Listing from the World Health Organization (WHO) on 12 March, Conditional Marketing Authorization from the European Commission on 11 March and Emergency Use Authorization by the US Food and Drug Administration on 27 February. The single-shot COVID-19 vaccine has also been granted Interim Order authorization in Canada on 5 March.

It is also being used to vaccinate South African health workers as part of an implementation study. The country abandoned its original plan to roll out the AstraZeneca vaccine after a small trial showed that vaccine was ineffective in preventing mild and moderate infection by the B.1351 variant.

South Africa announced on Sunday that it expected 2.8 million J&J doses at the end of April to expand its vaccination programme. It also announced that it had secured an order of 30 million doses from the company but did not divulge the expected delivery date of the bulk of its order.

J&J Tested on Diverse Populations

So far, the J&J vaccine is in fact the only vaccine to have been rigorously clinically trialled on the B.1.1351 variant that first emerged in South Africa and has now reportedly spread to some 16 other countries. 

Those states reporting on the presence of the B.1.351 variant, namely Angola, Botswana, Cameroon, Comoros, DR Congo, Eswatini, Gambia, Ghana, Kenya, Malawi, Mauritius, Mozambique, Namibia, Rwanda, South Africa, Zambia and Zimbabwe, according to the Africa Centers for Disease Control (CDC).

“The availability of the vaccine candidate is subject to its successful approval or authorization by the national regulatory authorities of AU member states,” according to the company’s press statement.

The J&J vaccine has been tested on almost 44 000 people from four continents, including 7,000 South Africans, most of whom were exposed to the B.1351 variant. The vaccine showed 57% protection against moderate disease, 85% protection against severe disease and 100% protection against death.

Globally, the J&J vaccine demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. 

In addition, South Africa’s Aspen Pharmacare will assist to manufacture the vaccine and support shipments to the AU member states, according to the company.

Gavi in Talks With Indian Government Over SII supplies

Meanwhile, lat last week the global vaccine alliance, Gavi, announced that COVID-19 vaccines produced by the Serum Institute of India to lower-income economies that as part of COVAX “will face delays during March and April as the government of India battles a new wave of COVID-19 infections”.

“COVAX and the Government of India remain in discussions to ensure some supplies are completed during March and April,” added Gavi

According to the agreement between Gavi and SII, the company is contracted to provide COVAX with the SII-licensed and manufactured AstraZeneca vaccine to 64 lower-income economies participating in the Gavi COVAX AMC, alongside its commitments to the Government of India.

 

Image Credits: NBC News.

Pakistani health workers getting vaccinated with donated Chinese Sinopharm vaccines.

ISLAMABAD – (EXCLUSIVE) A controversial plan to sell Russia’s Sputnik V COVID-19 vaccine to wealthy citizens in Pakistan has been put on hold following a dispute between the government and the private pharmaceutical company involved over the vaccines’ sale price, Health Policy Watch has learned.

Meanwhile, Transparency International – Pakistan appealed to Prime Minister Imran Khan to “cancel” the private importation of COVID-19 vaccines altogether, citing concerns with price and the potential for corruption.

“Pakistan is one of the first countries to allow the private sector to import and sell COVID-19 vaccines and [this] will provide a window of corruption, as there are possibilities some of the government vaccines may be sold to …private hospital[s],” Transparency International stated in a letter to the Prime Minister’s office, also obtained by Health Policy Watch.

Public health experts have also expressed disquiet about how a two-tier system would deepen inequality, allowing wealthy citizens who can pay to move to the front of the vaccination queue. 

The arrangement would also enable private buyers to obtain a vaccine [Sputnik V] whose clinical trial results have significantly outperformed the donated Chinese Sinopharm vaccines that are currently being rolled out by Pakistan’s public health authorities to health workers and other priority groups.

And the vaccine deals set a precedent for other low- and middle-income countries. Along with Pakistan, Brazil, Indonesia, and the Philippines, as well as Thailand and the United Arab Emirates are also reportedly weighing, or in the process of creating, a private market vaccine channel.

Government Initially Gave Sputnik Sales Go-ahead

In early February, Pakistan health authorities granted emergency use authorization for Russia’s Gam-COVID-Vac (Sputnik V) vaccine and gave permission to Ali Gohar Pharmaceutical (AGP), a private pharmaceutical company, to import and sell the vaccine.

Last week, AGP brought the first shipment of 50,000 Sputnik V doses into Karachi – but disagreement over price has put the private vaccination rollout on hold.

Initially, the government had approved private importation without fixing a price. But it later classified COVID-19 vaccines in the “hardship” category of medicines, which enables the Drug Regulatory Authority of Pakistan (DRAP) to set a maximum price.

The government then fixed the sale price at around $55 for two doses. But AGP says this is too cheap, while Transparency International believes is too high.

According to Transparency’s letter to Prime Minister Khan, “the federal cabinet has fixed the maximum retail price of Sputnik-V Russian vaccine at PKR8449 (US$54.46) for two doses and China’s Conividecia at PKR4225 ($27.30) per injection”.

However, said Transparency, the global price set for the Sputnik-V is $10 per dose.

“This means that, internationally, the two doses of Sputnik V are available at $20. However, the approved price for its commercial sale in Pakistan is 160% higher than the international price,” said the letter.

The price cap came from the Ministry of National Health Services Regulations and Coordination (NHSRC). Confirming this, NHSRC secretary Aamir Ashraf Khawaja also defended the government’s decision of allowing the private sector to import COVID-19 vaccine.

Russian military personnel receive Sputnik V vaccine

In a letter written to Transparency, Khawaja said that Pakistan remains committed to fighting COVID-19 with “everything available” at its disposal, including private vaccinations.

“This is expected in a large country like Pakistan, with a population over 220 million. The government, therefore, as a deliberate policy tool, allowed private sector to import vaccines to cater to those segments of the society which were not on the immediate priority list of the government,” said Khawaja in his letter.

“Government is fixing the maximum retail price, leaving room for competition and free market dynamics. It may also be added that COVID-19 vaccine market dynamics entail the sale in large quantities, typically in millions, and it is not easy for small players to access small number of doses,” said the letter.

Company Has Reservations About Price Cap

When asked for its response to DRAP’s decision to cape the price on privately imported vaccines, the AGP official said that “obviously company has reserved some appropriate steps about it”. 

Sources close to the company said that it had been planning to sell the double-dose vaccine for at least $70 and it may not sell its current stock at all now.

Meanwhile, DRAP spokesperson Akhtar Abbas said that medicine prices are fixed by the federal government and DRAP can only recommend prices on technical grounds.

He said that the reconsideration of the Sputnik-V vaccine set price was possible only on the advice of the federal Cabinet and, as far as he knew, Cabinet had not passed any directions to the regulatory authority.

Abbas added that if the company had any reservations about the pricing of the vaccine, it must submit these to the pricing committee of the DRAP.

Ellen ‘t Hoen, from South Centre, said that although the World Health Organization (WHO) had not finished assessing Sputnik’s efficacy and safety, the vaccine has been approved for emergency use by certain countries.

She added that it was “only a matter of time” before COVID-19 vaccines became “big business”. She also said that now India is planning to impose export controls on vaccines, more countries will start to look at China and Russia for supply.

Pakistan has given Emergency Use Approvals to a number of vaccines, including the Pfizer, AstraZenca, SinoPharm and Conividecia vaccines, as well as Sputnik-V.  However, so far only the Chinese-donated SinoPharm is being administered to healthcare workers and people above age 60.

Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said its members were not focusing on selling vaccines to private companies.

 “The major international vaccine makers, who are members of our federation, fully appreciate the public health emergency and therefore are focusing all their efforts on meeting the requests of governments or their appointed health authorities; as well a COVAX,” said IFPMA Director General Thomas Cueni.

The manufacturer of Sputnik V has submitted dossiers to the World Health Organization (WHO) and the European Medicines Agency for approval.  In February, a peer reviewed study of Sputnik’s clinical trial reults in The Lancet  found it to be safe and effective.

Asked to comment on the reports of the private market vaccine arrangements being laid in Pakistan and other countries, neither WHO’s Pakistan country office, nor WHO’s global headquarters in Geneva, had replied as of press time.

Image Credits: Ministry of Defence of the Russian Federation.

The manufacturing of the Oxford/AstraZeneca COVID-19 vaccine.

The European Medicines Agency (EMA) has officially authorized expanded capacity in three new vaccine manufacturing facilities on the continent producing AstraZeneca, Pfizer/BioNTech and Moderna vaccines – a move that the agency says should also help pharma suppliers ramp up their deliveries of now scarce vaccines to European Union bloc countries. 

At the same time, a surge of COVID cases in India has threatened a major supply chain of AstraZeneca vaccines to lower-income countries, produced by the Serum Institute of India (SII). 

The EMA statement issued on Friday, said the approval of the Halix manufacturing plant in The Netherlands, producing the AstraZeneca vaccine’s active substance, along with approvals of another Pfizer plant and a Moderna plant expansion, should “increase manufacturing capacity and supply of COVID-19 vaccine supplies in the EU,” after weeks of vaccine shortages and disputes with manufacturers over delivery delays. 

But it was unclear whether the EMA moves would also help ease  tensions between Europe, the United Kingdom and low- and middle-income countries (LMICs) over scarce vaccines, and particularly AstraZeneca supplies.  In the case of AstraZeneca, the newly EMA authorised plant was already producing vaccines that were being  shipped abroad.  

AstraZeneca is the major vaccine supplier to LMICs – through the WHO co-sponsored COVAX initiative. Some of the AstraZeneca doses bound for COVAX are also manufactured in Europe, including at the Halix plant, one of four operated by the pharma firm in the EU. 

Gavi Announces Delays in COVAX  Supplies From India  

At the same time AstraZeneca expands in Europe, the Serum Institute of India, which is the largest single supplier to the COVAX facility, is diverting some of its promised doses to meet India’s domestic needs. This, in the face of a major COVID surge on the subcontinent. 

The delays in delivery to COVAX of some 90 million AstraZeneca doses to some 64 low-income countries was announced Thursday by Gavi, the Vaccine Alliance – which is co-sponsoring the COVAX facility alongside the World Health Organization. 

“Deliveries of COVID-19 vaccines produced by the Serum Institute of India (SII) to lower-income economies participating in the COVAX Facility will face delays during March and April as the Government of India battles a new wave of COVID-19 infections,” said the Gavi statement. 

To date, COVAX has been supplied with 28 million AstraZeneca vaccine doses produced by SII, and was expecting an additional 40 million doses in March, and up to 50 million doses in April, according to the Gavi statement. 

The announcement set no new date for the deliveries, saying only that, “COVAX and the Government of India remain in discussions to ensure some supplies are completed during March and April.”

Pfizer & Moderna Sites Approved 

Among the other sites to now have received formal EMA approval, are a Pfizer facility in Marburg, Germany, which began production in February of both active substances and finished vaccine products – joining three other Pfizer manufacturing sites in the EU. EMA storage guidelines of the Pfizer vaccine were also relaxed, allowing the transport and storage of vials between -25 to -15˚C, instead of the previous requirement of -90 to -60˚C, based on updated evidence that the vaccine’s ultra-cold requirements are less extreme than previously thought. 

Meanwhile, the EMA approval of an expansion in Moderna’s vaccine manufacturing site in Visp, Switzerland, will enable the company to fulfill a major new order for an additional 150 million doses of the mRNA vaccine to the bloc, purchased in February, and due to be delivered in the third and fourth quarters of 2021.  That is in addition to 160 million Moderna doses already purchased earlier, a Moderna spokesperson said, noting that the deliveries of a total of 310 million Moderna doses for 2021 remain on track. The EU also has the option to purchase an additional 150 million doses for delivery in 2022, Moderna has said. The vaccines are being produced in Visp by the Swiss-based company Lonza, with which Moderna forged a partnership in 2020.

Moderna’s active vaccine ingredient has been produced at the Visp site since mid-December; that is then sent to Spain or France for “fill and finish”.  Swissmedic, Switzerland’s regulatory agency, also granted approval to the expansion of the Visp site 15 March.  A total of 6 million Moderna vaccine does are to be delivered to the Swiss Confederation in the first six months of 2021, out of a total contract of some 13.5 million doses – an agreement that is separate from the EU purchase.   

India Retains Vaccines As New COVID Wave Threatens Country 

India’s decision to temporarily curtail exports by the Serum Institute, the world’s largest COVID vaccine manufacturer, comes on the heels of a new COVID infection wave. 

Some 47,474 new infections and 225 daily new confirmed deaths were recorded on Thursday, a sharp increase from two weeks ago – bringing India up to 11.8 million total cases and 160,949 total deaths. The spike in cases is likely due to the relaxation of restriction and public health measures over the past couple weeks, experts said. 

Only 3.4% of the population has received at least one dose of a COVID-19 vaccine. Over 55.5 million doses have been administered in a country of 1.3 billion, a rate which is much slower than in the United Kingdom, US, and Israel. 

India’s Pivotal Export Role Means Big Ripple Effect For Delays 

India has exported over 60 million doses of the AstraZeneca COVID-19 vaccine to 77 countries, including supplying 28 million doses to COVAX, which have been distributed to over 50 countries.

But now, the Indian government is reportedly keeping the majority of the 2.4 million doses that SII produces daily to expand its domestic immunization campaign. Vaccinations will open to those over the age of 45 in early April, with the goal of inoculating 300 million people by August, according to the government.

In a press briefing on Thursday, John Nkengasong, director of the Africa Centres for Disease Control and Prevention, noted the supply interruptions, saying that he “truly feels helpless that this situation is going to significantly impact our ability to fight this virus.”  

John Nkenkasong, Director of the Africa Centres for Disease Control, appealed for equitable distribution of COVID-19 vaccines on Thursday, saying there was no need for a vaccine war.

However the Serum Institute site is not the only one in the AstraZeneca network, and hopes are that vaccines from elsewhere can still be recruited to fill the supply chain to low-income countries in need. 

“AstraZeneca, which uses a novel supply chain network with sites across multiple continents, is working to enable initial supply to 82 countries through COVAX in the coming weeks,” noted the Gavi statement. 

At least 10 African countries have yet to receive any COVAX vaccines whatsoever – along with another 10 other low-income countries elsewhere in the world. 

Impact of Tightening Export Restrictions on Global Vaccination Campaigns

Beyond the COVAX facility, SII is critical in the broader global supply chain of AstraZeneca’s vaccine. India exported five million doses to the UK, four million to Brazil, seven million to Bangladesh and three million to Saudi Arabia in January and February through direct commercial deals.  

The delays in India’s vaccine deliveries could thus disrupt vaccination campaigns globally and may even cause some campaigns to temporarily halt, as in the case of Nepal. Nepal received a total of 2.3 million doses from India between January and March, partly through COVAX, commercial deals, and a donation from India.

Nepal suspended its vaccinations on 17 March due to an insufficient supply of doses. India’s export restrictions “will affect us and the entire world,” said Jhalak Sharma, chief of Nepal’s National Immunization Program. 

“Many countries around the world, poorer ones in particular, are counting on India,” said Olivier Wouters, assistant professor of health policy at the London School of Economics, in an interview with the New York Times.

Indian government officials have so far refuted claims that India has imposed a vaccine export ban, as such, although officials have also conceded that “everything other than India is on hold for the time being; India is the priority.”

New Rules Allow States To Block Export Requests To Countries With High Vaccination Rates – LMICs Exempted

Earlier this week, the European Commission tightened rules by which member states reject vaccine export requests, under an emergency mechanism that will be in place for the next six weeks. 

However, low- and middle-income countries that are part of the COVAX’s “Advance Market Commitment” list would be exempted from the export restrictions, as the EC affirmed its commitment to “international solidarity…[and] humanitarian aid.” 

While the decision to authorise or reject export requests will still be left up to member states, the rules specifically allow states to block shipments to countries that have a higher vaccination rate than the EU – which only has 10% of its population vaccinated. 

Countries may also weigh export requests in light of the epidemiological situation in the destination country, and whether the destination country for the doses restricts its own exports of vaccines or raw materials. 

The policy is expected to affect the UK the most, although Israel and Canada could also be impacted by the stricter export rules – Canada depends on the EU for almost its entire vaccine supply. 

Since December, a total of 77 million doses have been exported from the EU and the UK has received 21 million of these doses, Ursula von der Leyen, President of the European Commission, highlighted at the virtual Euro Summit on Thursday. 

“While our Member States are facing the third wave of the pandemic and not every company is delivering on its contract, the EU is the only major OECD producer that continues to export vaccines at large scale to dozens of countries,” said von der Leyen in a press release on Wednesday. 

“We want to make sure that Europe gets its fair share of vaccines,” and that exports don’t “risk [the] security of supply in the European Union,” said von der Leyen at a joint press conference with Charles Michel, President of the European Council, on Thursday.

“With this mechanism we have a certain leverage, so we can engage in discussion with other major vaccine producers,” said Valdis Dombrovskis, European Commissioner for Trade, at a press briefing. 

UK Issues Mild Reaction – Member States Stop Short of Backing New Regulations

A spokesperson for the British government responded to the new rules, saying: “We are all fighting the same pandemic – vaccines are an international operation…And we will continue to work with our European partners to deliver the vaccine rollout.”

At the Euro Summit on Thursday, EU leaders emphasized that they would not damage supply chains essential for the production and distribution of vaccines, despite the vaccine shortage crisis.

“Regarding the export regime we said we had absolutely no desire to disturb the global supply chain, but also that we of course have an interest in ensuring that the companies that have made contracts with us remain truly loyal to those contracts,” Angela Merkel, the German Chancellor, told reporters. 

“We are, as the EU, the part of the world that is not only supplying itself but also exporting to the wider world – unlike the US, unlike Britain,” she added.

The move to expand restrictions was criticized by pharma executives. 

“Should it really come to export restrictions, that would be a ‘lose-lose’ situation for everyone, also for the members of the European Union,” said Sabine Bruckner, the Swiss country manager for Pfizer. 

A statement by the European Council, which represents EU member states, issued a diplomatically worded statement that avoided endorsing the new European Commission policy – saying only that “accelerating the production, delivery and deployment of vaccines remains essential and urgent to overcome the crisis.”

-Updated 29.03.2021

Image Credits: AstraZeneca, AstraZeneca.

WHO Director-General Dr Tedros Adhanom Ghebreyesus

COVAX has run out of COVID-19 vaccines to supply the last 20 countries in the world that have not yet started vaccinations, and it urgently needs a donation of 10 million doses from either manufacturers or countries that have piiled up surplus doses, according to World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus.

While 36 countries have not yet started vaccinations, 16 of these are due to receive COVAX deliveries within the next two weeks, Tedros told the WHO bi-weekly pandemic briefing on Friday.

“That leaves 20 countries who are ready to go and waiting for vaccines. COVAX is ready to deliver, but we can’t deliver vaccines we don’t have,” said Tedros, who set a global target of vaccination drives in all countries within the first 100 days of 2021.

He blamed “bilateral deals, export bans, vaccine nationalism and vaccine diplomacy” for causing delays in “tens of millions of doses” for COVAX. 

“COVAX needs 10 million doses immediately as an urgent stop-gap measure so these 20 countries can start vaccinating their health workers, and older people within the next two weeks.”

Although the WHO director refrained from mentioning any countries by name, India’s Serum Institute, the world’s largest vaccine manufacture, has interrupted planned deliveries to COVAX in March and April of tens of millions of AstraZeneca doses, diverting the vaccines to domestic use following a new spike in cases in the country. The suspension of deliveries was confirmed by Gavi, The Vaccine Aliance on Thursday.  (see related story).

‘Plenty’ of Countries That Can Afford to Donate

Appealing for donations of vaccines that have WHO emergency use listing (EUL) from manufacturers and countries, Tedros said that “there are plenty of countries who can afford to donate those with little disruption to their own vaccination plans”.

Only Pfizer, Moderna and AstraZeneca have WHO EUL. Four vaccines at different stages in the process of being assessed for EUL, and “at least one” was expected to be approved by the end of April, according to Tedros.

So far, 177 countries have started vaccinations, and COVAX has distributed more than 32 million vaccines to 61 countries in a single month. 

WHO’s COVAX representative, Bruce Aylward, acknowledged that political leaders were under incredible pressure from their citizens to deliver vaccines but stressed that “it’s the right thing to do to make sure everyone has access to vaccines”.

“We also have an economic reason to get to the world’s economy going, and we also have a health security reason because of variants,” stressed Aylward.

Criminals, Corruption and Fake Vaccines

The Director-General also warned of the danger of criminals exploiting the “huge global unmet demand for vaccines” and urged people not to buy vaccines outside government-run vaccination programmes as these could be “sub-standard or falsified”.

“A number of ministries of health, national regulatory authorities, and public procurement organisations have received suspicious offers to supply COVID-19 vaccines,” warned Tedros.

“We’re also aware of vaccines being diverted and reintroduced into the supply chain, with no guarantee that cold chain has been maintained. Some falsified products are also being sold as vaccines on the internet, especially on the dark web,” he warned.

WHO’s technical lead on COVID-19 Maria Van Kerkhove

Maria van Kerkhove, WHO’s Technical Lead on COVID-19, said that there had been a 15% increase in COVID-19 cases in the past week, with all six WHO regions showing increases.

She stressed that while “we might be tired of the pandemic, it is not finished with us”, and that masks, hand-washing and our “mixing patterns” were the only measures that could keep us safe in the face of the global shortage of vaccines.

“Fifteen months in, people want this to be over, but we still have to put in the work. All of us have a role to play here in reducing transmission and this includes during holidays,” stressed Van Kerkhove, referring to the looming Passover and Easter holidays.

“All of us want to spend time with our families and travel around and, and there are safe ways to be able to start to do this, but we need to think about what each of us are doing every day. We will get to a point where this pandemic will be over. I promise we will get there, but we need to put in the work now to drive transmission down,” she stressed.

 

Kenya’s capital, Nairobi and four other counties go into lockdown as COVID-19 cases surge

NAIROBI – Kenya has suspended parliament and banned church gatherings in its capital, Nairobi, and four other counties as the country records its highest number of COVID-19 deaths since the pandemic started last year and amid a surge of positive cases.

President Uhuru Kenyatta on Friday announced partial lockdown and instituted new curfew measures to start from 8pm to 4.00am, the suspension of county assemblies and the closure of bars in Nairobi as the country experiences a third wave of the deadly virus.

The four counties affected by the lockdown are Kiambu, Nakuru, Machakos and Kajiado.

He said the number of confirmed COVID-19 cases had increased to 15,916 on 21 March, up from 4,380 in January. The  positivity rate has jumped from 2.6% to 22% in the same period. The lockdown was necessary to avert a health crisis.

“This tells us that our rate of infection has gone up 10 times between January and March 2021. Indeed, it is a clear indication of a new trend, that now Kenya is squarely in the grip of a third wave of the Pandemic,” said Kenyatta, adding that the peak is likely to flatten by mid-May.

Data shared by the Ministry of Health on Friday showed that 1,463 people tested positive for COVID-19, from a sample size of 8,976 tested in the last 24 hours – 26 deaths had been reported in the last 24 hours.

A total of 1,080 patients are currently admitted in various health facilities countrywide, while 3,825 patients are on Home Based Isolation and Care.

Some 121 patients are in intensive care units, 35 of whom are on ventilatory support and 77 on supplemental oxygen, nine patients are on observation, 81 patients are on supplementary oxygen with 68 of them in the general wards and 13 in the High Dependency. Kenya has one of the highest cumulative incidence rates among the African Union member states in the Eastern region.

Strict Lockdown Regulations

Kenyatta said the spike in new cases called for urgent and drastic measures and that lockdown was crucial to avert a national health crisis. Some of the lockdown rules include:

  • Suspension of gatherings at places of worship in the five counties;
  • Banning of the sale of alcohol and suspending the sale of alcohol at bars and restaurants;
  • Meetings or events including social gatherings are limited to 15;
  • Funeral, cremations and other interment ceremonies, must be conducted within 72 hours of confirmation of death; and limited to 50 mourners and
  • People travelling to Kenya must be in possession of a negative COVID-19 PCR Certificate, acquired no more than 96 hours prior to arrival; with the PCR Certificate also having been validated under the Trusted Travel platform for those travelling by air.

Spike in New Cases Likely Drive by Two Variants

Kenya’s increasing COVID-19 cases are likely driven by the highly transmissible variants of concern B.1.1.7 and B.1.351 detected in January, according to a report released by the Africa Centres for Disease Control on 23 March.Scientists say although there are increased cases of variants the lack of adherence to COVID-19 protocols is also leading to increased infections.

Professor Joachim Osur, technical advisor for programmes at AMREF Africa, says Kenya was experiencing high infection rates among communities. He said hospitals are getting overwhelmed, Intensive Care Units (ICU) in hospitals are full, not everyone needing ICU care is getting it and the number of deaths is steadily increasing.
“I think the reason is that we stopped taking precautions,” said Osur, adding that people started behaving irresponsibly when schools, churches and markets re-opened.

“I am worried that schools are running and children who are super spreaders are infecting the older populations,” said Osur.

More Surveillance Needed To Curb Further Infections

“It has to be a systematic analysis to see that the variant has evolved over time,” says  John Nkenkasong, head of Africa CDC.

“Unfortunately Kenya is not technologically competent enough to be monitoring the strains of the virus we have and the mutations that are happening. So, we are unable to know at this point if it is the variants but it could be a reason,” said Osur. “Mutations happen everyday but it is possible that we have more than one variant and it is possible that they are more aggressive.”

Earlier this week Nkenkasong said additional resources and efforts are required to track the virus through surveillance. He said vaccinations should continue. “We do not think the situation in Kenya has evolved to a threshold past where the vaccine should not be used,” he said.

The vaccine uptake in Kenya has been slow with only 640, 000 people vaccinated so far. On 3 March Kenya received 1 million Oxford/AstraZeneca vaccines from the COVAX facility.

“These simple public health measures are what will save us but people are not taking them seriously. The responsibility relies on individuals- more community education is needed on what this virus is and what it should be done to the community,” said Osur.

Image Credits: US news.

Last Ebola patients leave a treatment centre in the Democratic Republic of Congo this week, marking the countdown to declaring the end of the pandemic.

(Geneva Solutions) – As Guinea and the Democratic Republic of Congo discharge their last Ebola patients, following the most recent outbreak, new research points to the virus’ long lasting ability to lurk within the body. So while the 42 day countdown begins to the day when both countries can declare that the current outbreak is over, preparedness remains key to heading off future infections everywhere in the region, warns the International Federation of Red Cross and Red Crescent Societies (IFRC).

With no more confirmed cases and the discharge of the last Ebola patient from a health centre in DRC’s Katwa city on Monday, followed by the discharge of the last Ebola patient in Guinea, on Tuesday night, the latest outbreak of Ebola virus in central and west Africa ma now have ended.

However, global health officials warn that vigilance needs to remain high.  That is particularly true, in light of the recent evidence that the Guinea outbreak was apparently triggered by an Ebola survivor who carried the virus unknowingly for five years before transmitting it to someone else.

The Republic of Guinea was one of the countries at the center of West Africa’s Ebola virus epidemic that raged from 2014-2016 claiming 11,000 lives.  The DRC faced a major outbreak in 2018, that concluded a year later, but has been followed by others. During the most recent DRC outbreak in February, 12 cases were confirmed leading to six deaths – while 1,737 people were vaccinated against the virus, according to the WHO – with IFRC teams on the ground providing key support.

“The main objective of the Red Cross’ intervention on the ground, over the past two years or so, is to ensure Ebola is contained, and does not spread to other areas and across borders into countries such as South Sudan and Rwanda,” Dr Balla Conde, who is managing the IFRC response on the ground with a team of 100 health workers, told Geneva Solutions.

In the case of Guinea, the outbreak declared on 14 February 2021 in the N’Zerekore region led to 14 confirmed cases, leaving five people dead.   However, the even more worrisome aspect of the current Guinea outbreak was its apparent source – a survivor of Guinea’s previous 2014-2016 outbreak who appears to have harbored the virus for as long as five years, before infecting someone else.

“”Patient O” in 2021 Guinea Outbreak Harbored the Virus for Five Years.

The new research findings about “Patient O” of the 2021 outbreak in Guinea hold serious implications for the longevity of one of the world’s most deadly pathogens.

The discovery was made in the course of contact tracing and genetic sequencing of virus strains in Guinea’s present-day patients, which linked those cases back to strains prevalent in 2014 and a recovered patient from that time, according to three independent studies released. Given the lengthy interval between the two events this comes as a “shock” to virologists.  It had been previously believed that the outbreak was transmitted by an animal such as a bat.

“This is absolutely stunning,” Dr Angela Rasmussen, a virologist at Georgetown University in Washington DC, wrote on Twitter, adding. “This is bad for a whole host of reasons, including the further stigmatization of Ebola virus disease survivors.”

Previously, the longest reported duration of virus persistence in an EVD survivor was 531 days, reported on in 2016. That case involved  a 56-year-old survivor whose seminal fluid contained the virus 17 months after the onset of the disease.  According to the reports, he sexually transmitted the virus to someone else in early 2016, triggering further infections in Guinea, one of which was carried back to Liberia.

While it is rare for survivors to harbour and transmit the virus after such a long period, scientists now understand that the virus can remain in the body for a sustained period of time in places such as the eyes, spinal cord and testes – which are not easily reached by immune defences.

Naomi Nolte, IFRC emergency communication coordinator, called the new research findings “worrying” – although she emphasised that the findings remain preliminary.

The overriding message, she said, is that people must “remain vigilant, keep physical distancing, disinfect spaces and ensure that people have all the right information.”

Teaching community workers about Ebola surveillance

 

Potential for EVD Sexual Transmission Could Stigmatise Ebola Survivors.

Reports linking some of the episodes of virus resurgence to sexual transmission could wind up stigmatising  Ebola survivors, warned Gwen Eamer, public health expert in emergencies at the IFRC.

“Although the findings of the virus sticking around for a long time may be true, it is important that we do not jump to conclusions that it is due to sexual transmission as this has very real impacts on survivors,” said Eamer.

Surveilance Key to Containment

Meanwhile, IFRC officials said that they are supporting local health systems by building capacity for community-based disease surveillance. In these cases, trained community volunteers seek out and report cases of people whose symptoms appear to meet EVD definitions, and take blood samples to confirm suspected cases.

Such training is vital as many common illnesses, including influenza, malaria, typhoid and cholera have similar symptoms of vomiting, and fever to Ebola.

Another pillar of preparedness is ensuring safe and dignified burials – since the Ebola virus is also very easily transmitted after the person has died of the disease.

“We know from the previous outbreak in Guinea and neighbouring countries that burials and funerals were key drivers of transmission, because of traditional burial practices that involve touching the body,” said Eamer.

To ensure “safe and dignified burials, we provide the team with personal protective equipment,” said Eamer, adding that the teams actively support the family, while “adapting funeral rituals ensuring that the dignity of the deceased remains intact, taking into account the mental health, social, cultural and religious perspectives.”

There is a higher level of trust today between communities and Red Cross field workers – something that represents a very positive shift from the 2013-2016 Ebola epidemic – and makes it easier for the organization to do it’s work, adds Nolte.

She adds that Covid-19 also has highlighted to policymakers the importance of preparedness for other highly contagious viruses, e.g. Ebola, which pose “perpetual” threats to countries’ economies and societies.

However, the new research findings have also renewed calls for more widespread EVD immunisation campaigns across larger parts in West and Central Africa.

That would require more funding, including some 8.5 million Swiss francs that the Red Cross says it needs for the Ebola response – which has only garnered less than a one million so far.

“We really don’t want to wait for another humanitarian shock like we had during the last outbreak in Guinea in 2013-2016 or are in DRC between 2018 and 2020,” said Nolte.

  • Updated on 25 March, 2021
Originally published in Geneva Solutions. Health Policy Watch Watch is collaborating with Geneva Solutions, a non-profit platform for constructive journalism covering International Geneva

Image Credits: WHO African Region, Geneva Solutions .

european commission
Katalin Cseh a Hungarian MEP associated with the  Renew Europe Group.
EP Plenary session – Preparation of the European Council meeting of 25 and 26 March 2021 and Digital Green Certificate

European Parliament members (MEPs) expressed overwhelming support for a coronavirus-related “Digital Green Certificate” to ease travel within the European Union, voting by a more than two-thirds majority to accelerate approval by the summer.  

But parliamentarians also warned that all efforts to recover from COVID-19 will be void unless Europeans are vaccinated more quickly. 

“We need to speed up vaccination – that is the only light at the end of the tunnel,” said Katalin Cseh a Hungarian MEP associated with the  Renew Europe Group, on the opening day of a two-day debate at the European Union Summit  happening today and tomorrow on the “Digital Green Certificate”.

“We need to increase production capacities to set up more ambitious targets for deliveries to work together with manufacturers, and also to ramp up production,” said Cseh. 

“Only vaccines can offer us a way out of the crisis; we need to do our utmost to help boost vaccine production and ensure more transparency, predictability, and supply of the vaccines, so that we can speed up the vaccination campaigns across the EU,” said Ana Paula Zacarias of Portugal. 

The majority of the MEPs who took the floor said the Digital Green Certificate proposed by the European Commission on 17 March, would support the much-needed recovery of the travel and tourism sector. 

With 468 votes in favor, 203 against, and 16 abstentions, MEPs took advantage of an urgency procedure (Rule 163), which allows for faster parliamentary scrutiny of the Commission’s proposals. The MEPs will next mandate negotiations over the proposal, to be considered during the parliament’s next plenary session (26 – 29 April). 

Certificate To Offer Proof of COVID Vaccination, Recovery Or Negative Test Result
digital green certificate
The stages of the Digital Green Certificate System in practice.

The certificate would be free of charge, in digital or paper format, with a QR code to help ensure security and authenticity.  It would offer proof that a person has either been vaccinated, received a negative test result, or recovered from COVID-19, and has antibodies. 

Other key provisions are that the certificate will be recognized in every EU member state, and it will pave the way for the establishment, or re-establishment, of  full freedom of movement inside the EU during the COVID-19 pandemic. 

“The Commission will build a gateway to ensure all certificates can be verified across the European Union, and will support member states in the technical implementation of certificates,” said Commission Vice-President Maroš Šefčovič. Šefčovič said the Commission aims to have the system in place by June. 

MEPs Call For Legal Action Over AstraZeneca Vaccine Delays & Unreported  Doses 
AstraZeneca vaccine

In terms of speeding up Europe’s vaccine rollout, the MEPs focused most of their fire on the recent AstraZeneca delays in vaccine deliveries. 

Concerns over the failure of the company to meet its EU commitments have been compounded by the  recent discovery of almost 30 million undelivered AstraZeneca doses stashed  in an Italian factory. 

During the debate,  several MEPs speakers called for legal action against the manufacturer.  

Iratxe Garcia Perez, Group of the Progressive Alliance of Socialists and Democrats in the European Parliament, Spain, called the reports about AstraZeneca’s undelivered doses “the straw that broke the camel’s back.” 

“We’re not talking about the fact that they are not complying with their commitments and the contracts. Basically, they’re laughing at us in our faces,” she said. 

The AstraZeneca vaccines were discovered by Italian police in a raid of a factory in Anagni, a town near Rome.  Italian government officials were reportedly unaware of the vaccine stash until the EU’s internal market commissioner, Thierry Breton, launched an investigation, and then tipped off Italian police, according to the Italian newspaper La Stampa. 

Some EU sources said that the jabs had initially been bound for the UK – before being  blocked by Italy after the country introduced new rules on vaccine exports, EU sources told the paper. 

However, in a statement on Wednesday, AstraZeneca said that 16 million of the vaccine doses were simply awaiting quality control to be disbursed to EU countries.  

Another 13 million doses were manufactured outside of the EU, and then brought to the plant for the “fill and finish” process of putting the vaccine into vials, the company said. These doses are awaiting shipment to low and middle-income countries, in the framework of the WHO co-sponsored COVAX global vaccine rollout initiative, which is supported by the EU. 

“It is incorrect to describe this as a stockpile. The process of manufacturing vaccines is very complex and time consuming. In particular, vaccine doses must wait for quality control clearance after the filling of vials is completed,”  the company said.  

Garcia Perez and other MEPs, however, blamed  AstraZeneca for still moving too slowly on the EU vaccine deliveries. 

“[We] have to act firmly and take actions against a pharmaceutical company because they are undermining the prestige of other companies that are meeting their obligations. So I would urge the Commission to get down to work and do something about this flagrant attack against the commitments that the company undertook, “ said Garcia Perez. 

Independence From Pharma, Though Not Through Export Ban 
Martin Schirdewan, of The Left Group in the European Parliament, Germany.

Although several MEPs called for legal action against AstraZeneca to restrain it from exporting vaccines to the UK and elsewhere in the world, others warned that an export ban could result in further delays in Europe’s vaccine rollout. 

“Export bans can lead to retaliatory measures and that could lead to lower production of vaccines in the EU. We could end up in the worst possible situation where nobody benefits,” said Martin Schirdewan, of The Left Group in the European Parliament, Germany.

Schirdewan, however, called on the European Commission to “give up all contracts with the pharmaceutical companies and release the patents to produce the vaccines.” 

“We have made ourselves dependent on the pharmaceutical companies. We have made ourselves dependent on a market that regulates nothing, shown clearly by AstraZeneca stockpiling 29 million doses in Italy that have just been accidentally discovered.” 

“Let’s create a joint European strategy that we can use to combat the virus. Let’s coordinate healthcare, let’s deal with the social and economic consequences of this pandemic for our populations.” 

 

Image Credits: Jan Van De Vel, European Commission, gencat cat/Flickr, Alexis Haulot.

rapid antigen test
A new study suggests that administration to travelers of a rapid antigen test upon arrival at their destination, may be just as effective as quarantine requirements, to stop imports of COVID-19 cases.

A new study published by a consortium of UK-based airline industry interests suggested that administration to travelers of a rapid antigen test upon arrival at their destination, may be just as effective as quarantine requirements, to stop imports of COVID-19 cases.

The study, which reviewed case studies of airport testing procedures elsewhere, claims that a single on-arrival antigen test is as effective as a ten-day-self isolation period in reducing imported cases of COVID-19, while testing after five-seven days of quarantine may catch as many as 90% of cases. Specifically, it found that: 

  • Air passenger testing after five days of quarantine in Iceland is between 83% and 90% effective. 
  • Testing after seven days in Toronto and Paris is between 84% and 90% effective. ​
  • Single tests on arrival in Canada (Toronto-Pearson Airport), France (Paris-Charles de Gaulle Airport), Jersey and Iceland detected between 54% and 76% of infected travellers.

“Real world evidence supports a significant reduction in current UK 14-day quarantine policy,” claimed the studies authors who also disputed a previously published Public Health England (PHE) paper that  had concluded  airport testing would identify only ‘7%’ of virus cases.

The study was prepared for a consortium of British airlines interests, including Virgin Atlantic, Heathrow Airport, and the International Airlines Transportation Association. 

“We believe that international travel can safely restart at scale, using a risk-based, phased easing of testing requirements and border restrictions, that follows the scientific evidence,” Virgin Atlantic’s chief executive Shai Weiss said, upon publication of the review.

Britain has currently banned all foreign travel, except for essential work, education, or health reasons. The ban, along with the current quarantine requirement, was supported by the PHE paper. The new study finds that this significantly underestimates the effectiveness of passenger testing.  

The study has been submitted to Britain’s Global Taskforce, which is set to review how and when travel should restart on 12 April. 

Image Credits: Wikimedia Commons: Nemo.

 

African health officials appeal for more COVID vaccines after current supplies run out in some countries

About 10 African countries have yet to receive any doses of a COVID vaccine, while at least one country, Rwanda, has already run out of the doses that it received through the WHO co-sponsored COVAX facility, said WHO’s African Regional Office on Thursday, citing this as evidence of the vaccine inequalities that continue to mark the battle against the pandemic.  

“It is unfair. I believe that some high income countries are looking to vaccinate their entire populations while others, including most countries in our region, are struggling to reach a significant proportion of at-risk populations,” said Dr Richard Mihigo, Immunization and Vaccines Development Program Coordinator at WHO’s African Regional Office, speaking at a WHO/AFRO press briefing on Thursday.

Under the COVAX initiative, countries are supposed to receive some 20% of their COVID-19 vaccine needs, with the shipment of the doses officially beginning in Accra, Ghana, just weeks ago.  So far, some 7.7 million doses have been administered in 32 African countries through COVAX or national initiatives, the WHO African region officials said.  And some 44 countries have received vaccines through COVAX or other channels.  

At the same time, however, some 10 countries have not received any vaccines at all, and have no idea when the next shipments will be, while other countries are already running out of the doses that they received. 

Rwanda Already Used Its COVAX Vaccine Supplies

Rwanda, for instance,  received about 240,000 doses of the Oxford/AstraZeneca COVID-19 vaccine through the WHO co-sponsored COVAX Facility on March 3. It received a further 103,000 doses of the Pfizer vaccine, as the first African country to administer the vaccine that requires ultracold storage. 

But only 20 days after it commenced vaccination, Rwanda has already administered all of its doses. Rwandan government officials said they did not know when the next shipment will be received, especially since the new guidelines that prioritise India and Europe over the rest of the world, delay vaccine deliveries to Africa. Rwanda has a population of about 13 million and needs to vaccinate 7.8 million people to achieve herd immunity.

“When the COVID vaccine was made available, we already had a programme that was built from the community to national level, so we just plugged into the existing system, and that made it easier and faster to make it happen,” said Dr Sabin NSanzimana, director of the Rwanda Biomedical Centre, at the WHO briefing, describing the country’s experience. “And the thing is that, deploying a vaccine rapidly, without waiting is the best way you can actually stop the progression of this virus.”

However, that success has now been tinged with anxiety as Rwanda awaits more vaccine doses to arrive.

And while countries like Rwanda are rapidly and impressively vaccinating their people against COVID-19 with the very limited doses available, they are largely helpless regarding getting additional doses, said Dr John Nkenkasong, Director of the Africa Centres for Disease Control and Prevention. 

Speaking at a back-to-back Africa CDC briefing, Nkenkasong urged global leaders to pursue equitable access to vaccines, saying:  “There is absolutely no need, absolutely no need for us as a world, as humanity, to go into a vaccine war to fight this pandemic. We’ll all be losers. 

John Nkenkasong, Director of the Africa Centres for Disease Control has appealed for equitable distribution of COVID-19 vaccines, saying there was no need for a vaccine war.

“I remain hopeful that the power of humanity will prevail,”  Nkenkasong added, “I strongly believe that we should continue to be our neighbour’s keeper and the only way we do that is to exercise that strong sense of solidarity and coordination and with common wisdom. I remain hopeful that wisdom will prevail over time.”

Worries That Serum Institute Doses Will Be Kept In India or Diverted To  European Union   

Officials also are worried about the news that AstraZeneca vaccine doses produced by the Serum Institute of India, Africa’s main vaccine supplier either directly and through COVAX, may be kept in India or diverted to the European Union. 

The Oxford/AstraZeneca vaccine is the main vaccine that African countries are receiving through the COVAX  initiative – as well as through bilateral deals. And most of those doses are produced by the Serum Institute. 

In February, however, Adar Poonawalla, CEO of vaccine producer, Serum Institute of India (SII), announced his company had been directed to prioritise the needs of India, currently undergoing a surge in COVID cases. 

“SII has been directed to prioritise the huge needs of India and along with that balance the needs of the rest of the world. We are trying our best,” Poonawalla said on Twitter.   

That was confirmed by a GAVI announcement Thursday, which stated that some 90 million doses due to be supplied to COVAX in March and April may not be delivered – as a result of the Indian government’s decision to divert doses domestically.  

In addition, Africa CDC officials fear that Africa COVID-19 vaccines produced in Europe could also be threatened by new guidelines issued by the European Commission that limit the export of coronavirus vaccines to countries outside the bloc. The guidelines stipulate that the EU countries may curb the exportation of vaccines for six weeks to destinations with fewer COVID cases or higher vaccination rates – although the restrictions explicitly exclude exports to low-income countries that are participating in COVAX. 

Ursula von der Leyen, president of the European Commission, justified the guidelines and said the world is in the crisis of the century and the commission is not ruling anything out. 

“I’m not ruling out anything for now, because we have to make sure that Europeans are vaccinated as soon as possible. Human lives, civil liberties and also the prosperity of our economy are dependent on that, on the speed of vaccination, on moving forward,” Leyen said.

Threats to Africa’s vaccine plans

Also speaking at today’s briefing, Anthony Costello, Professor of Global Health and Sustainable Development, University College London, supported the call for speedier delivery of vaccines to Africa and said the continent’s plan to vaccinate 60% of its citizens by mid-2022 can only be achieved if there is quick access to doses of the vaccines. 

While expecting access to improve before the end of 2021, Costello said the continent needs to vaccinate about 35% of its citizens before the end of the year and this would require about 800 million doses of COVID-19 vaccines.

“If you’re going to reach a 60% target of vaccinating the continent by the middle of next year, which I think is the aim, then, in this year, if you want to reach 35% of the African population, you’re going to need 800 million doses. Let’s say the population of Africa is 1.2 billion, you’re probably going to need to vaccinate 727.5 million people by the middle of next year, that’s going to mean you’ll need almost 1.5 billion doses (of Oxford/AstraZeneca COVID-19 vaccine), so that’s a huge challenge,” Costello said.

Costello expressed confidence that Africa’s health infrastructure  was adequate to ensure a speedy roll-out if the doses became available. “I’m pretty confident that Africa can get there because I think the immunisation infrastructure in Africa is generally not bad. The figures have come up dramatically over the past 10 or 15 years. I think Africa’s public health structure is often better than Europe, to be honest,” he said.

Earlier this month, Africa CDC also announced plans to hold a major conference in April to discuss the local production of vaccines, as one avenue to address the continent’s vaccine shortages. 

Speaking at the time, William Kwabena Ampofo, Chairperson of African Vaccine Manufacturing Initiative, called for a “roadmap” to increase vaccine production that will facilitate immunization of childhood diseases and enable Africa to control outbreaks of highly infectious pathogens

 

Image Credits: Johnson & Johnson, WHO African Region .

3D print of a spike protein on the surface of SARS-CoV-2, enabling the virus to enter and infect human cells.

NEW DELHI – Scientists have sequenced a new “double variant” of the coronavirus first identified  in India – along with a handful of other variants of concern that are appearing during the second biggest wave of the virus since the pandemic began.

The new double variant, bearing two significant mutations in the coronavirus spike protein, dubbed E484Q+L452R, could be associated with higher infectivity and with a capacity to evade antibodies, government experts have warned. Alone or together, the mutations E484Q and L452R “have been found in about 15-20% of samples and do not match any previously catalogued VOCs”,said the Ministry of Health and Family Welfare in a press release, 

The two variants both appear to “confer immune escape and increased infectivity”, the Ministry said; immune escape refers to the ability of a variant to evade immunity conferred by a prior infection. 

The government also said that there is not yet sufficient evidence to establish a link between the new mutation and the surge of COVID-19 cases occurring now in some states of India. India reported 53,476 new cases in the last 24 hours, of which 31,855 are from Maharashtra.  “The variants of concern and a new double mutant variant..have not been detected in numbers sufficient to either establish a direct relationship or explain the rapid increase in cases in some states,” the press statement issued by India’s Ministry of Health and Family Welfare.

The double mutation has been found mostly in the Western state of Maharashtra which is seeing a massive surge in COVID-19 cases. Several cities in Maharashtra including Mumbai and Pune had massive number of cases in the first wave of the pandemic last year. However, since mid-February, the state has seen a massive spike of cases yet again. 

“We have seen this double mutant E484Q+L452R in 206 samples in Maharashtra and a varied number in Delhi. In Nagpur, we found a substantial number of samples with this mutation- about 20%. But, the data so far does not show that the surge is related to this mutant,” said Dr Sujeet Kumar Singh, Director of India’s National Centre for Disease Control, speaking at a press conference on Wednesday.

Nagpur is one of the cities in Maharashtra which saw the beginning of the surge of  Covid-19 cases in India from mid-February. 

Variant of ‘Interest’, Not Yet ‘Concern’ According to WHO Criteria

Speaking at the press briefing, however, Singh also downplayed the significance of the double mutation at this point. 

He said that according to WHO criteria, the double mutation could be called a “variant of interest”, but it has not yet been  established as a “variant of concern” in the same way as the variants first identified in the United Kingdom, Brazilian and South Africa – also circulating in India. 

The WHO has established three classifications for the identification of SARS-CoV2 mutations, including variants under investigation, variants of interest and variants of concern. 

Singh said that further investigations of the Indian mutations are underway. “Only when the variant has public health impact, increases severity of the disease does it become cause of concern,” explained  Singh of the classifications. 

In an interview with Health Policy Watch, Dr Shahid Jameel, chair of the scientific advisory committee of the Indian SARS-CoV-2 Consortium on Genomics (INSACOG), echoed that message. The consortium is a group of 10 laboratories that carry out genomic sequencing and analysis of circulating COVID-19 viruses. The consortium tests international travellers, their contacts, and   community samples. It has so far tested more than 10,000 cases.

“We do not need to worry about the double mutation, but we have to be concerned,” Jameel said. “Both these mutations allow the virus to infect better and evade antibodies. But we do not know how much it will affect the surge on the ground.” 

Variants of greatest concern are typically associated with a higher viral load,  increased transmissibility and  also “immune escape” – referring to variants that can evade immunity conferred by a prior infection. 

The Genomic Consortium is primarily concerned with variants that carry mutations in the characteristic spike protein of the coronavirus, which eases the virus’s way into cells, allowing it to infect individuals with COVID-19. On that spike protein, one region of greatest interest is the “receptor binding domain”, said Jameel.  

In the cases of mutations that facilitate “immune escape”  changes occur in that receptor binding domain, Jameel explained: “In the [spike protein’s] receptor binding domain, there is a path called the ‘receptor binding motif’. It contacts the cell, and from there the virus is able to enter the cell. However, antibodies [built from previous infection or immunization] can prevent its binding to the cell. 

“If the virus changes the process slightly, so that it is not recognised by antibodies it is able to enter cells more effectively,” said Jameel.

Another variant associated with “immune escape” -N44OK- also has been found in the country’s southern states of Kerala and Telangana. This variant, however, has also been reported in 16 other countries including the United Kingdom, Denmark, Singapore, Japan and Australia. 

Sequencing Is Simple – Linkage to Community Spread Is More Difficult

“While sequencing is simple, linking the sequences to community spread depends on various reports and the kinds of samples taken,” said Jameel. “To link it epidemiologically is time consuming and difficult. The mutant strain will be figured out in time, but the important thing is to stop the spread of the virus,” said Jameel.

Even in Nagpur, the cases are spreading in areas of the city that were relatively unaffected in the first wave last year, and that the population in these areas were susceptible to the virus.

A nation-wide survey showed only one out of 5 people have been exposed to the virus. But in cities such as Mumbai, Pune, Delhi the sero-surveillance shows high levels of high levels of sero-positive cases, of more than 50%.

“The most important thing to remember is that viruses will not mutate if they are not allowed to replicate. Therefore, we have to only suppress the chain of transmission to stop mutations of the virus. Testing, quarantine, and containment will limit the spread of the virus,” said Dr Vinod Paul, chairperson of India’s Covid-19 task force.

Mutations Will Not Affect India’s Vaccination Drive

These variants should  not, however, impact India’s vaccination drive, other government officials have said . “It is well established by research studies in literature and published literature, that both the vaccines that are available in our country are effective against both the UK and Brazil variants. The research regarding the South African variant is ongoing at the moment,” Balram Bhargava, director general of Indian Council of Medical Research (ICMR), said.

More than 50 million people have been vaccinated with one dose so far in the country. Much has been said about the slow pace of vaccination in the country covering only about 3% of the population. 

In the first drive of vaccination which started in January, the government only allowed healthcare workers to take the vaccine. In March, the government started the vaccination drive for people above 60 years old and people above 50 years old with co-morbidities. It has now announced that those who are 45-years and more are eligible for the vaccine.

Covid-19’s Second Wave in India

Since mid-February COVID-19 cases have been steadily rising in India. From an average of about 12,000 cases a day at the time, more than 40,000 are getting reported in the last few days.

Just six states in India – the western states of Maharashtra and Gujarat, the central state of Chhattisgarh, the northern state of Punjab and the southern states of Kerala and Karnataka –  have accounted for some 80.63% of the new cases reported in the last 24 hours, said India’s Health Ministry.

Along with any locally emerging variant, another major concern is the high number of samples identified with the UK variation (B.1.1.7) in the northern state of Punjab. The Punjab government said that 81% of the samples examined between January and early March have been found to be from that coronavirus lineage. The explanation for that is likely to be international travel – insofar as the UK is home to a large Punjabi diaspora. 

In the press conference, Singh attributed the rise in cases to the large number of people that were not infected in the first wave, and have not been vaccinated either, and so they are still  susceptible to COVID-19. With a year of the pandemic, pandemic fatigue has set in and people are perhaps lax about COVID appropriate behaviour, he said. 

Image Credits: Flickr – NIAID.