WHO recommends postponing routine dentist visits in areas with high community transmission of COVID-19.

The World Health Organization recommended postponing routine dental visits in areas with community transmission of COVID-19 in new guidelines released last week. 

Many dental procedures can generate aerosols, or tiny solid or liquid particles that contain disease-causing pathogens. If dentists were unknowningly treating coronavirus infected patients, aerosols laden with SARS-CoV-2, the virus that causes COVID-19, could contaminate other surfaces, or infect staff or other patients if inhaled.

To minimize the risk of COVID-19 spreading in dental care settings, WHO recommended that patients avoid seeking non-emergency oral care, such as routine check-ups or aesthetic treatments. Routine visits can resume once community transmission is controlled, and only clearly traceable clusters of infection are present in the community

In the meantime, service providers can offer phone or virtual consultation services for patients experiencing mild symptoms, including prescription of analgesics and antibiotics.

However, patients should still seek their dentist’s care in the case of dental emergencies, such as severe swelling, bleeding or intense pain. Seeking emergency oral care at the dental office can free up general emergency rooms for those with COVID-19 specific complications. Patients should call their clinics ahead of time, and confirm that they do not have COVID-19. 

Dental Workers Should Take Extra Precautions

Healthcare workers should take extra precautions to wear proper protective equipment and adhere to cleaning and hygiene protocols. Dental workers should wear respirators and full protective gear when performing aerosol-generating procedures. 

The guidance has encouraged installation of exhaust fans and whirlybirds or high-efficiency particulate air (HEPA) filters to purify the air and maintain safe ventilation throughout the clinic. It warned against warned using air recirculation devices such as split conditioners, which can disperse droplets or aerosols containing the virus throughout a room. 

Appointments should be adequately spaced out, and patients should arrive alone, wear a mask, and keep at least 1 metre apart from other patients in the waiting room. 

Before starting any procedure, the patient should gargle with 1% hydrogen peroxide or 0.2% povidone iodine for 20 seconds and spit in a disposable cup instead of spittoon. All surfaces should be cleaned, and instruments should be sterilized and disposed after each clinic visit. 

WHO recommends that patients who have confirmed COVID-19 or COVID-19 symptoms seek care for dental emergencies in care centers trained to safely care for coronavirus patients.

Image Credits: Flickr: locomomo.

Surveillance officer in Lagos tracks down suspected COVID-19 cases and contacts of cases.

This week, the Africa Center for Disease Control (Africa CDC) will be launching a continent-wide antibody study to measure the true extent of the COVID-19 pandemic in Africa, where reported coronavirus cases are much lower than initial dire predictions.

Africa CDC Director John Nkengasong announced the study at a regular Thursday press briefing. Just a week earlier, the number of confirmed cases of COVID-19 in Africa crossed one million, making Africa the last continent (apart from Oceania) to reach the sobering threshold. 

While the continent has a number of lessons for the rest of the world regarding handling COVID-19 and pandemics, its comparatively lower testing rate is raising concerns that  the official figures from the region do not accurately capture the true extent of pandemic. 

At the outset of the COVID-19 pandemic, Microsoft founder, Bill Gates predicted it could claim about 10 million lives in Africa. His wife and co-chair of the Gates Foundation, Melinda Gates, added that without drastic actions, COVID-19 could lead to dead bodies lining the streets of Africa.

But Africa has recorded fewer COVID-19 cases and deaths than other parts of the world. Despite the poor quality of health systems across the African continent, the case fatality rate (CFR) in Africa is among the longest globally, hovering around 2% against Europe’s 6.3%, South America’s 3.4%, North America (3.9%), and a global CFR of 3.7% as at August 7.

Dr Michel Yao, Emergency Operations Manager at WHO’s regional office for Africa, noted that earlier predictions (of doom) were based on the assumption that Africa would experience widespread community transmission, and weak health systems would be overwhelmed by the outbreak.

“That was a bit worrying for us – the idea that the system could be easily overwhelmed and the disease could spread faster. This was taken into consideration for the prediction,” Yao told a press conference on Thursday. 

“We are pleased to see that [the worst] did not happen,” Yao added. 

But other officials were more pessimistic. A WHO Africa technical officer warned that “the peak was yet to come,” in a statement to Al Jazeera.

Early Confinement Measures May Have Helped Slow Virus, But Reopening Led To New Cases

Yao noted that the decision of African countries to quickly implement lockdown measures may have helped slow  down the spread of the virus. 

“African countries had confinement measures earlier – closing schools as well as limitation of movements. All these reduced the spread,” Yao added.

However, widespread food insecurity and economic hardship forced many African countries to reopen their economies, resulting in an increase in cases. The case of South Africa, which now ranks among the top five countries with the highest coronavirus caseload, suggests that the country’s lockdown measures may have failed.

But Yao also  noted that African countries had given themselves time to build up treatment and laboratory capacities while under lockdown.

And even in South Africa, there is gradual decline in the daily number of new cases reported, noted Dr Matshidiso Moeti, WHO’s regional director for Africa.

“It is something that is starting but we need to observe for a little bit longer before we say firmly that this is a trend,” Moeti said last Thursday

Besides South Africa, Moeti noted a number of other countries that are seeing reduction in the number of cases to a similar degree – about 20% fewer cases were reported in the first week of August compared to the second week of July at the time of the press briefing. These countries include Nigeria, Côte d’Ivoire, Cameroun, Republic of Congo, Mauritania, The Democratic Republic of the Congo, the Central African Republic, Botswana, Liberia and Benin Republic. WHO also noted that while there has been a 13% increase in the number of COVID-19 cases in the African Region in the past week, it was lower than the 18% increase recorded during the previous reporting period.

“We still have countries [where] there was an initial increase in cases [after government relaxation of measures]. Now we are starting to see a decline. But the take home is we need to monitor this and just assure ourselves that the decline continues,” Moeti said.

Delays & Shortages in Testing Could Lead To Undercounting Cases

Several African countries have been facing a shortage of testing kits, raising concerns that the continent’s relatively low number of reported COVID-19 cases was due to lack of testing. 

For the first time, donor countries that often come to Africa’s aid are among the worst hit by the pandemic and are therefore prioritising their countries’ citizens, stockpiling PPEs and testing kits. Only 5 countries in Africa have carried out at least 500,000 COVID-19 tests and many have tested less than 1% of their population.

While 5.4% of tests conducted globally test positive for COVID-19, Africa has the second highest positivity rate of all seven continents at 11.6%. 

But the high positivity rate may be due to responders across the continent rationing tests to only those who showed symptoms of disease, who are much more likely to test positive. Moeti also said that the positivity rate has not changed in African countries that are expanding COVID-19 testing, indicating that current testing is capturing most cases in these countries.

“Some countries have increased their testing per capita while maintaining a low positivity rate. They include countries such as Mauritius, Rwanda, Cape Verde and Botswana,” Moeti added.

High Prevalence of SARS-CoV-2 Antibodies in Populations Indicates Higher Spread of Virus Than Testing Positivity Implies

Some countries are finding that many of their citizens are testing positive for antibodies for SARS-CoV-2, the virus that causes COVID-19. This may indicate that the virus has spread to more citizens than the testing positivity rate implies. For example, Mozambique has less than 3,000 confirmed cases of COVID-19 in the entire country, but serological surveys found SARS-CoV-2 antibodies in 5% of households in the city of Nampula and 2.5% of households in the city of Pemba alone. 

Addressing a press conference, Africa CDC director John Nkengasong said “What is important is far fewer people are coming down with the disease. How many people are infected and asymptomatic on our continent? We don’t know that.”

Still, the continent has a relatively lower COVID-19 death rate than expected, even in light of signs of wider spread of the virus. 

With the exception of South Africa, many countries are not observing excess deaths due to respiratory-related symptoms. While death and birth registration lags in Africa compared to other regions of the world, WHO AFRO officials noted that COVID-19 deaths remained low in African countries with efficient death reporting systems, implying that these African countries are seeing a true lower death rate than initially predicted.

Health experts have attributed the lower than expected case-fatality rate to Africa’s comparatively young population, which may withstand the virus better than populations with more older people. COVID-19 death rates are highest in people over the age of 65 years old. 

Collaboration &  Innovative Thinking Help African Countries Leverage Strengths

Another aspect of the African response has been the cooperation seen among various countries, and the coordination role being played by the African Centers for Disease Control (Africa CDC). 

Dr. Ahmed Ogwell Ouma, Africa CDC’s Deputy Director, told Health Policy Watch that the center is supporting African countries in centrally accessing testing kits and consumables including PPEs. It is also assisting in capacity development and risk communication.

With the COVID-19 not ending anytime soon, the WHO and Health Ministers of Rwanda and Niger republic noted that African countries are already taking localised actions that leverage on already existing infrastructure and capacity for the pandemic. 

Moeti mentioned that in Nigeria, advocacy by community leaders encouraged more people to go for testing. In Mauritania, university students are helping to ramp up surveillance while in Kenya, over 79,000 community health workers and 15,000 youth champions have been trained to help raise awareness among 17 million people through household visits and other activities.

Moreover in Zimbabwe, the integration of COVID-19 into polio eradication systems is providing real time information for decision making regarding both diseases. Cote d’Ivoire has also cascaded training to around 10,000 health workers in all of its 113 health districts.

Rwanda is one of the  countries in Africa that is actively deploying innovations to aid its COVID-19 response. Its decision to deploy robots to reduce contacts of health workers with persons that tested positive is already producing results, according to the country’s Health Minister Dr Daniel Ngamije. He revealed that less than ten healthcare workers in the East African country have contracted COVID-19. 

The country is also actively driving the adoption of cashless transactions to prevent possible transmission of the virus from one person to another through cash.

“We came to realise that financial cash transactions were also one of the sources of transmitting the disease. The government encouraged the use of mobile money’s cashless system by facilitating telecom companies to not charge those transactions, reducing the cost of transaction so that people can take advantage of not necessarily doing their transactions by exchanging money but they can do payment or transfer of money using technology,” the Minister said.

He added that the country also embraced digital tools for collecting data, which allow users to reduce the amount of materials and labor required to track down the virus. 

“While we were doing contact tracing, initially we were using some [paper] forms. But those also can be a vector for transmission of the disease, or just bring a lot of work. Then we went through a system of using iPad and mobile phone for collecting information especially when we are doing our contact tracing. We have an app which can be used on the devices. Even when there is no connection, later on the information can be analysed when a person is joining a place where there is connection. This was very helpful for investigation teams,” Ngamije explained.

Decentralisation Allows Countries To Cover More Ground
A surveillance officer visits far flung villages in Lagos to track down COVID-19 cases.

As the pandemic continues its spread and cases continue to rise, Rwanda and several other African countries are decentralising their pandemic response efforts. Over 30 countries have decentralised lab testing capacities, according to the WHO. This means that more testing facilities are emerging thus easing pressure on central facilities. In Nigeria, testing facilities increased from one to over 40. 

Beyond decentralising testing, African countries are also decentralizing case management and treatment. 

“We started with one national referral lab that is able to test COVID-19 in February, today we are with 10 sites in the country where COVID-19 can be tested,” Rwanda’s Health Minister said.

He added the country is already piloting home management of cases in order to decentralise case management. 

“We have started to test home-based management of COVID-19 and we are starting piloting model to see if this can be feasible in some settings in some households – treating COVID-19 at home without necessarily picking the person to isolation center because after 6 months of the pandemic, government is incurring a lot of expenditure and it is a lot of pressure to the health system. We should be anticipating ahead what might happen if there is generalised community transmission. We are already thinking how to manage the scenario,” Ngamije said.

This is a welcomed development for the WHO which has also heralded the introduction of pool testing in Ghana and elsewhere to maximise the limited testing kits and rapidly screening large populations to quickly identify positives.  

New Challenges Emerge As Airplanes Take Flight Over Africa Once More
Checking traveler temperatures at border crossings

With Africa’s airspace opening up and international travel resuming, it is becoming easier to move experts, utilities, PPEs, testing kits and additional around. The WHO is already sending experts to hotspot countries. But there are concerns that this could also lead to the resumption of  importation and exportation of positive cases. In Rwanda, the government said it is making efforts to ramp up testing of travelers. 

“Measures are in place to contain any arrival of imported cases. Even when people are traveling from Rwanda now (because we’ve opened our airspace), we have strict measures to test them before traveling. We are trying to avoid any new imported cases and also avoid exporting cases while we contain transmission of the disease within the country itself,” the country’s Health Minister said.

With major aspects of economies across Africa already reopened, there are concerns that this could make citizens suggest that the pandemic is over. Yao noted that this needs to be addressed and measures need to be enforced. But some cities are already mandating and enforcing the use of face masks and other measures. In Osun state, Nigeria, individuals caught not wearing face masks are being charged and sentenced. Yao noted that for Africa to continue to maintain its good outing with COVID-19 and to start flattening the curve will require encouraging its citizens to continue to abide by the various health advisories. 

“It is not over yet. It is why some of the preventive measures need to be enforced again.  We are noticing in some countries that people are no longer using masks, not observing physical distancing. Countries should continue working. Decentralising is critical, we must be anticipating to avoid a worse scenario,” Yao concluded.

Image Credits: WHO Africa, P Adepoju/HP-Watch, WHO Africa.

Photo Credit: Nenad Stojkovic

Health experts and access advocates warn that rich countries may leave poorer countries in the lurch as states scramble to preorder doses while COVID-19 vaccine candidates enter late stage clinical trials.

The United Kingdom on Friday secured 90 million doses of two promising COVID-19 vaccine candidates, joining a growing group of rich countries buying up doses of promising vaccine candidates before they hit the market. 

It’s “urgent” for the UK government to clarify how it will ensure equitable global access to these vaccines in light of the deals, said Alex Harris, head of Global Policy at the research foundation The Wellcome Trust in a press release. 

“Without this clarity, the risk increases that other rich countries will seek to strike similar bilateral deals, potentially securing significant oversupply, leaving insufficient volumes of vaccine for the rest of the world,” added Harris. 

Access advocates decried the move, accusing the UK of fueling ‘vaccine nationalism’ and joining other rich countries to ‘hoard’ the vaccine before it even hits the market.

“This latest vaccine deal shows the government shows a complete disregard for its own claims about supporting equitable global access to Covid-19 vaccines,” said Heidi Chow, senior campaigns and policy manager at Global Justice Now. “This UK-first approach is fueling vaccine nationalism as rich countries scramble to hoard vaccine supplies, leaving poorer countries without access. The fastest way to end this pandemic is through global collaboration.”

Health experts have generally agreed that a successful COVID-19 vaccine should first be given to healthcare workers, and then to high-risk groups in areas with high transmission of the virus. But many are concerned that the deals being struck between vaccine producers and high-income countries will leave poorer countries with potentially higher numbers of COVID-19 cases without access.

“Instead of accelerating an arms race for access to COVID19 tools by competing with other countries to get preferential access to potential vaccines, the UK should be taking a collaborative approach,” said Diarmaid McDonald, lead organiser for Just Treatment, a patients advocacy group in the UK. 

“If we want to manage this pandemic successfully the UK Government need to be championing global collaboration and coordination,” added Saoirse Fitzpatrick, advocacy manager for STOPAIDS. “This means supporting international efforts to facilitate the sharing of research data to speed the vaccine discovery process, and ensuring that patent monopolies do not drive up the prices of these vaccines and cause supply shortages.”

Countries Scramble to Secure Vaccine Stocks Through Bilateral Deals

The UK signed its latest deals with Novavax and Janssen Pharmaceuticals, a branch of Johnson & Johnson, promising to support clinical trials for both companies’ vaccine candidates. Neither vaccine candidates has entered the last phase of clinical testing before being eligible for regulatory approval. 

Earlier this year, the UK had signed a contract with Sanofi/GSK for 60 million doses of their investigational COVID-19 vaccine, and has also secured deals with the University of Oxford/AstraZeneca and the BioNTech/Pfizer alliance for stocks of their trial vaccines.

The UK deals follow the United States’ announcement of the largest pre-order contract to date of an investigational COVID-19 vaccine. The Trump administration announced Wednesday that it had ordered 300 million doses of Moderna’s investigational COVID-19 vaccine to be manufactured, ready to be deployed if the vaccine shows success in Phase III clinical trials. 

Oxford/AstraZeneca, Moderna, and BioNTech/Pfizer’s vaccine candidates have begun Phase III trials, aiming to enroll around 30,000 volunteers for each trial.

The European Union is also pursuing bilateral deals with pharmaceutical companies to secure doses of the vaccine for Europe. So far, it is in talks with Sanofi/GSK to buy up 300 million doses of their investigational vaccine.

One global initiative, the COVAX facility, aims to secure at least 950 million doses of any successful vaccine for low-income or lower-middle income countries. However, some low and middle income countries are in talks with banks to finance their own bilateral deals with vaccine producers, in an effort to avoid being left behind.

Even the World Health Organization is concerned about the implications of these deals.

“Excess demand and competition for supply is already creating vaccine nationalism and risk of price gouging,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus on Thursday. “This is the kind of market failure that only global solidarity, public sector investment and engagement can solve.”

Image Credits: Flickr: Nenad Stojkovic.

COVID-19 is not transmitted by food or food packaging, says WHO

There is ‘no evidence’ that the SARS-CoV-2 virus can be transmitted in food or on food packaging, said the World Health Organization on Thursday.

WHO’s Executive Director of Health Emergencies Mike Ryan made the comments in response to reports that a dozen frozen chicken wings imported into China’s southern city of Shenzhen tested positive for COVID-19, sparking concern that contaminated food could spur outbreaks of the coronavirus.

So far, China has already tested a “few hundred thousand” food samples for COVID-19, but only ten have tested positive for COVID-19, said the WHO on Thursday. And even though viral genetic material can be found on some surfaces, like packaged food, there is still no evidence that the coronavirus can be transmitted through food, emphasized the Organization.

In early July, China suspended imports of Ecuadorian shrimp for fear that the products could spawn COVID-19 outbreaks, after reports from the port cities of Xiamen and Dalian. And on Wednesday, the virus was identified on frozen shrimp packaging from Ecuador, during a routine inspection by officials in eastern China’s Anhui Province, according to Reuters. But so far, no human cases of coronavirus have been linked to the contaminated food.

“There is no evidence [that] food or the food chain is participating in transmission of this virus”, said Ryan on Thursday, at a regular press briefing. “People should not fear food or food packaging or processing or delivery of food…Our food, from a COVID-19 perspective, is safe.”

WHO Guidance Says Food-borne Transmission “Highly Unlikely” & Virus Can Be Killed By Cooking

It is “highly unlikely” that COVID-19 can be contracted from food or food packaging, states the WHO and the Food and Agriculture Organization of the UN (FAO), in their joint scientific guidance on food safety from early April. 

“We know that the virus can remain on surfaces for some time, but the virus can be inactivated on your hands if you wash your hands”, added WHO’s Technical Lead for COVID-19 Maria Van Kerkhove. “We have no examples of where this virus has been transmitted as a foodborne…viruses can be killed if the meat is cooked.”

Thus, sanitizing food preparation surfaces and cooking meals thoroughly can effectively kill most viruses.

“Coronaviruses cannot multiply in food; they need an animal or human host to multiply,” according to the WHO’s guidance on food safety. “There is no evidence to date of viruses that cause respiratory illnesses being transmitted via food or food packaging.”

Rather, the main drivers of COVID-19 transmission are respiratory droplets or aerosolized particles released from coughing and sneezing, or contact with contaminated surfaces.

Image Credits: Wikimedia Commons: Flixtey.

A doctor explains contraceptives to a young girl at the Sukhbaatar District Health Center, Ulaanbaatar, Mongolia.

Funding for research into sexual and reproductive health issues, ranging from HIV/AIDs to pregnancy prevention, comes from only three major donors, and the global recession caused by COVID-19 may shrink the funding landscape further.

“There’s a clear gap in investment to research and develop new products to meet people’s needs in low-resource settings. With a few funders stepping in to fill this gap, there are missed opportunities to make a real impact on the lives of people in LMICs,” said Nick Chapman, CEO of Policy Cures Research, the group that produces the annual G-FINDER reports.

“Looking to the future, not only are unprecedented funding levels being funneled towards COVID-19, but an impending global recession will undoubtedly have an impact on future development funding commitments and available funding to address other global health issues, like SRH,” added Chapman, in a press release.

The new G-FINDER Sexual & Reproductive Health report released Thursday also found that in 2018, US $1.4 billion of the US $1.7 billion invested in the area went towards HIV/AIDS research, dwarfing the paltry US $71 million that went towards all other sexually transmitted infection research worldwide.

“Strong global advocacy” and “sustained investment” have helped HIV/AIDS stay high on funders’ radars, said Maya Goldstein, lead author on the report.

But issues such as human papillomavirus (HPV) and HPV-related cervical cancer, the fourth most common cancer in the world, received just $52m in R&D funding in 2018. Maternal killers such as postpartum haemorrhage (PPH) and pre-eclampsia, a dangerous hypertensive disorder in pregnancy, received only US $4.4 million and US $12 million respectively in 2018.

The United States National Institutes for Health (NIH), the Bill and Melinda Gates Foundation, and the pharmaceutical industry represent the most significant donors to sexual and reproductive health research. The US NIH funded about two-thirds of the US $1.7 billion total investment.

“There’s a clear need and opportunity for more private and public sector investors to contribute,” said Goldstein. “The magnitude of [the top funders’] investments compared with others signals perhaps too heavy a reliance on a few organisations to support SRH innovation.”

 

 

Image Credits: UNFPA/Andrew Cullen.

Vaping, or the use of electronic nicotine delivery devices that vaporize nicotine-infused liquid, is linked to a dramatically higher risk of getting infected by COVID-19 in teens and young adults, according to a new study by Stanford University researchers.

The study, published in The Journal of Adolescent Health just ahead of International Youth Day on Wednesday, found that teens and young adults who vaped were five times more likely to be diagnosed with COVID-19.

Those who vaped and smoked traditional combustible cigarettes were seven times more likely to receive a positive COVID-19 diagnosis.

“Young people may believe their age protects them from contracting the virus or that they will not experience symptoms of COVID-19, but the data show this isn’t true among those who vape,” said the study’s lead author, Stanford researcher Shivani Mathur Gaiha, in a press release.

“This study tells us pretty clearly that youth who are using vapes or are dual-using [e-cigarettes and cigarettes] are at elevated risk, and it’s not just a small increase in risk; it’s a big one.”

The study analyzed self-reported data from 4,351 people between the ages of 13-24 across the United States. It found that those who had used e-cigarettes or conventional cigarettes in the past were also more likely to experience symptoms of COVID-19, and seek testing. 

The researchers found no relationship between only smoking traditional cigarettes and COVID-19 infection in this study. However, senior author Bonnie Halpern-Felsher, a professor of pediatrics at Stanford, said this may be due to the fact that few teens and young adults exclusively smoke combustible cigarettes in the United States.

“We need the FDA to hurry up and regulate these products. And we need to tell everyone: If you are a vaper, you are putting yourself at risk for COVID-19 and other lung disease,” said Halpern-Felsher.

Image Credits: Flickr: Mike Mozart.

Russia’s speedy approval of a COVID-19 vaccine on Tuesday has drawn widespread criticism from Health Ministers, researchers, and even a Russian pharma industry group. 

However, it has also spurred interest and offers to collaborate on testing the new vaccine in other countries, including from quarters as farflung as Israel and the Philippines.

The Russian COVID-19 vaccine, dubbed Sputnik V, is the first in the world to receive national regulatory approval; it was approved for public use even ahead of its Phase III trial. Additionally, results from earlier clinical trials have not yet been released to the public or the World Health Organization, sparking concerns from many experts that the country is jumping the gun in a bid to showcase Russia’s scientific prowess.

“It is not about being first, it is about having an effective, a tried and with that a safe vaccine,” German Health Minister Jens Spahn told the radio station Deutschlandfunk on Wednesday. “The problem is that we know very little because the Russian authorities are not being transparent. To have trust in such a vaccine I believe it is important to do the necessary testing even in times of pandemic and to make everything public.

“We know that as of now that there has been no Phase 3 testing, so no clinical trials with a broad spectrum of people. And with that it can also be dangerous to start too early.”

Jeremy Farrar, director of The Wellcome Trust, tweeted, “It is wrong to release any vaccine without robust assessment [of] safety & efficacy. This vaccine [has] not been robustly assessed & should not be released outside clinical trials.”  Rapid  release of Russia’s vaccine before testing was completed could jeopardize public trust in vaccines in general, he suggested. 

But the World Health Organization refrained from openly joining the chorus of criticism. A WHO spokeperson told Health Policy Watch that WHO experts were “in touch” with the Russian vaccine’s development team, and stressed that vaccine research protocols should be followed.

“Accelerating vaccine research should be done following established processes through every step of development, to ensure that any vaccines that eventually go into production are both safe and effective,” said the spokesperson.

Russia’s own Association of Clinical Trials Organizations has expressed concerns about the speedy approval, calling the vaccine a “Pandora’s box.”

“The rules for conducting clinical trials are written in blood. They can’t be violated,” ACTO Executive Director Svetlana Zavidova told Bloomberg News. “This is a Pandora’s Box and we don’t know what will happen to people injected with an unproven vaccine.”

Developed by Russia’s Gamelaya Institute, and funded by the Russian Direct Investment Fund, some 67 people were administered the vaccine in small Phase I and Phase II trials, including President Vladimir Putin’s own daughter, although no results or data have been released or shared with the World Health Organization, the latter a protocol followed by other vaccine developers. 

Russia has announced that healthcare workers will be among the first to receive the vaccine, starting in October 2020. However, a Russian Ministry of Health spokesperson told Science Insider that the current registration would not allow the vaccine to be used more broadly until January 2021, presumably after larger clinical trials have been conducted.  

Growing Interest From Other Countries In Testing Russia’s Vaccine

Despite the chorus of criticism, policymakers and experts in some quarters were taking a more positive approach, expressing interest in using or testing the Russian vaccine.

President of The Philippines, Phillippe Duterte told media outlets that he “trusted” the Russian vaccine, and offered to have himself  “publicly injected” to alleviate Filipinos’ fears.

Colorized electron micrograph of SARS-CoV-2 (yellow) attacking a dying cell (red)

The Russian vaccine was also stirring scientific interest in Israel, which has a 1 million strong Russian emigrant community.  

Zeev Rotstein, head of Jerusalem’s Hebrew University’s Hadassah Medical Center said that Haddassah, one of the country’s top hospitals, would collaborate in testing the Russian coronavirus vaccine candidate.

“We are playing a part in conducting safety and efficacy studies,” Rotstein said in an interview with The Jerusalem Post.  He noted that Hadassah, which has a worldwide network, would work in  collaboration with its new branch in Skolkovo, Moscow.  Hadassah became the first foreign medical center to open a clinic in Russia in 2018, at the Moscow International Medical Cluster. 

Israel, which is considered a biomedical powerhouse, should not be so quick to dismiss the Russian coronavirus vaccine, Rotstein underlined, saying that the country should not only  be betting on the success of US vaccine candidates.  In June, Israel signed a pre-order agreement wiht Moderna, the Boston-based firm that just embarked on Phase III trials of a COVID-19 vaccine candidate. 

 “I strongly recommend the authorities in Israel not focus only on the American companies that are manufacturing vaccines and not neglect the ability of Russian scientists,” Rotstein said. “I would have recommended that the foreign minister be in contact with the foreign minister of Russia in order… to not exclude the possibility that the vaccine be allocated to Israel too.

“There are a lot of accusations regarding Russian technology and science,” he added.  “But if you remember, the fact that they called it Sputnik V is to say to the world, ‘Remember who was first in space.’ Russia could be very advanced.”

He was referring to the Russian satellite Sputnik, the first to be launched into orbit in 1957, beating the United States in the early phases of the space race.   

In another interview with Israel’s Radio 103FM, Rotstein suggested that the vaccine was also being administered to a small number of patients at Hadassah via a compassionate use program, though it was unclear how that compassionate use would apply to a vaccine. 

“We expect to hear more information from the mayor of Moscow in a very short period of time,” Rotstein said. “We are in direct contact with our people in Moscow and we are getting information as it is available.”

Israel’s Health Minister Yuli Edelstein, himself a Russian emigrant, was a little more cautious.  He told a press conference on Tuesday that Israel was interested in holding discussions with Russia about its vaccine but only “if we are convinced that it is a serious product then we will try to enter into negotiations 

“We are following vigilantly every report, no matter what country,” Edelstein said. “We have already discussed the reports from the research center in Russia about the vaccine development.

COVID-19 Vaccine Race Takes On Space-Race Era Competition

The naming of Russia’s Sputnik 5 vaccine is yet another reflection of the way in which countries are racing helter-skelter to develop and procure potential vaccines on behalf of their own nations – first and foremost – with far less thought about the need for global solidarity of the kind that WHO has said it critical to beating the pandemic. 

While Russia pursues Sputnik 5, the United States is heavily invested in the COVID-19 vaccine candidate of the Boston-based Moderna, which entered Phase 3 clinical trials in late July after publishing early phase trial results and receiving a large dose of financial support from BARDA, a branch of the US Department of Health and Human Services (HHS).

On Tuesday, HHS ordered 100 million doses of Moderna’s investigational COVID-19 vaccine to be manufactured even as a massive 30,000 person Phase 3 trials was only getting underway. The doses will only be made available if the vaccine is proven to be safe and effective in the Phase 3 trial. 

The procurement contracts have been awarded to Moderna as part of Operation Warp Speed, a US government initiative to deliver 300 million doses of a safe effective vaccine to citizens by January 2021. The US Congress has allocated more than US $10 billion for the initiative. 

On Wednesay, Anthony Farci, director for the National Institute of Allergies and Infectious Diseases (NIAID) which has also invested heavily in the Moderna candidate, expressed “serious doubts” that the Russian vaccine had already been proven to be safe and effective. 

And like the race to space several decades ago, whether or not Sputnik V may already be in orbit, it remains to be seen which vaccine candidate – American, Russian, British – will be the first to land on the moon. 

Image Credits: Coronavirus from US NIH, Sputnik Rendition from Flickr: Kordite – adaptation by G Ren/HP-Watch, NIAID.

More than US $100 billion will be required just to scale-up manufacturing and ensure worldwide distribution of a coronavirus vaccine, said WHO Director-General Dr Tedros Adhanom Ghebreyesus in prepared remarks at a WHO press conference on Monday.

He said that the World Health Organization’s ACT Accelerator consortium has received only 10% of the funding that would be required for scale up and production of a new vaccine, as well as new COVID-19 treatments and diagnostics. 

However, Seth Berkley, CEO of Gavi, The Vaccine Alliance cited a much more modest requirement in an interview with Heidi News last week, republished today by Health Policy Watch. 

In his interview, Berkley said that a new COVID-19 vaccine could be produced and distributed for under $US 50 per dose. The vaccine arm of the ACT Accelerator is thus looking to raise US $2 billion to help secure 2 billion doses of the vaccine for low-income countries that cannot afford to purchase the vaccine themselves, as well as some stock for higher income countries that bet on the wrong vaccine candidate. 

According to Gavi’s documents on the vaccine investment case, some US $18.1 billion would be required to fund the final development, production, and deployment of all 2 billion doses.  

“But here’s the thing,” added Berkley, “the pandemic is costing the world $375 billion a month in lost GDP. If you look at the overall costs, the vaccine bill could be as high as $75 billion. That means that an effective vaccine that would help the economy recover would pay for itself in five or six days.”

GAVI is co-leading the vaccines pillar of the Act Accelerator with WHO and the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI). 

According to the latest update on the ACT Accelerator investments, about US $3.4 billion of the US $31.3 billion required has been pledged to the accelerator overall – or 10% of the requirements for drugs, diagnostics and vaccines. 

WHO, when queried about the discrepancy in data about vaccine investment requirements, did not reply.

The Challenge Will Be Delivering A Vaccine To Those In Need

Whatever the figure might be, it’s clear that the bigger challenge may be not in the vaccine’s development – but in delivery. 

“I believe that we will get COVID-19 vaccines that are both safe and effective, the challenge is going to be scaling up the production, paying for all of that, and preparing national systems to deliver this,” said WHO Health Emergencies Executive Director Mike Ryan. 

“Having an effective vaccine is only part of the answer… You have to have enough vaccine, you have to get enough people access,” he added. 

Some US $3.2 billion from the ACT Accelerator will be required to build up supply chains to safely deliver a vaccine in low and lower-middle income countries, according to the investment case. Upper-middle income countries and high-income countries are expected to cover the costs of distribution through their own national health budgets.

“This [US$ 100 billion] sounds like a lot of money and it is. But it’s small in comparison to the 10 trillion dollars that have already been invested by G20 countries in fiscal stimulus to deal with the consequences of the pandemic so far,” said Dr Tedros.

Dr Seth Berkley (left, during the Ebola outbreak) has led the Vaccination Alliance (Gavi) since 2011. | Gavi / Frédérique Tissandie

To facilitate equitable access to COVID-19 tests, treatments, and vaccines, WHO launched the COVID-19 Access Accelerator (ACT) in April. COVAX is the vaccine component of this initiative. It is led by WHO, the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI) and the Geneva-based Gavi, the Vaccine Alliance (GAVI). Heidi.news spoke with Gavi’s Executive Director, Seth Berkley, to discuss the challenges of what could be the most massive immunization campaign ever conducted.

Why it’s important. A vaccine is probably the only way to halt a pandemic that, according to WHO’s latest data, has led to more than 20 million reported cases and 750,000 deaths. More than 200 vaccine candidates are in development, of which three have entered the final phase of clinical trials. But potential demand by some 7.8 billion people is running headlong into what could be a precariously limited vaccine supply. Will rich countries preemptively snatch up available vaccines, as suggested by the behavior of the United States and some European countries, including Switzerland, which have pre-ordered millions of doses? And what if one of these countries is betting everything on the wrong candidate? These are some of the big questions now on the table.

Heidi.news: A recent article published in Science stated that “vaccine nationalism” threatens the global plan to distribute future COVID-19 vaccines equitably. Do you share the same concern?

Seth Berkley: Yes, we do. That’s why we’re building the COVAX mechanism. We have had the experience of the “swine” flu in 2009. So a small group of rich countries bought the entire stockpile of vaccines with only a few donations here and there. This could happen again. We may end up in a situation where about 30 countries have all the vaccines and 170 countries do not have access, at least initially. We know that vaccines will be a limited commodity for the next 12 to 18 months. The challenge is to stop the pandemic. It has to be seen as a global public health issue. People need to understand that in a pandemic situation we are only safe if others are safe. With an infection spreading at the speed of light, this solidarity is the condition for the economy, trade, exchanges, to resume.

HN: The United States and Europe are ordering hundreds of millions of doses of potentially effective vaccines in advance. Does that mean that we will not have the equitable access that you are advocating?

SB: Advance orders are a necessary mechanism for vaccine manufacturers to make the investment possible. Normally we have a global production capacity of about 1.5 billion vaccines that we need to continue to produce. That means huge investments for the new COVID-19 vaccines, which may require two doses. And, we don’t know which of these vaccines will be effective. In any case, we do know that there will not be enough vaccines, to begin with. So we need an equitable, but also effective, way to distribute it globally. This means first vaccinating the groups of people most at risk, namely health workers, who make up 3% of the world’s population, and the elderly (17%). And we need to do this at the global level, which is what COVAX is all about.

Seth Berkley announces the launch of the COVAX facility at a 4 June 2020 virtual event

HN: How does it work?

SB: The COVID-19 vaccine global access facility (COVAX Facility) consists of two parts. The COVAX Advance Market Commitment (AMC) is modeled on what Gavi usually does for other vaccines in developing countries. It is intended to enable the purchase and delivery of vaccines for developing countries based on funds from donors in rich countries. The AMC will provide guarantees to manufacturers to create sufficient global production capacity before vaccines are licensed. It will then purchase vaccines and help deliver them to 92 countries, representing half of the world’s population.

The second mechanism is the financing of vaccines for upper-middle and high-income countries. It is a pooled fund set up by contributing countries to guarantee them doses of various vaccines. There will probably be between 12 and 15 vaccines selected. This fund functions as insurance by providing access to a wide range of vaccines, including those for which there have been no specific pre-orders. Therefore, if the candidate in which a country has invested fails, it will still have access to other vaccines for about 20% of its population.

The advantage of such a global program is that it allows production capacities to be optimized.

“Health care workers should be the first to be vaccinated.”

HN: How did you choose which people to vaccinate first?

SB: Health care workers should be the first to be vaccinated. Not only are they the most at risk, but they are essential to the proper functioning of the healthcare system. Older people are a challenge because we know they develop a weaker immune response than younger people. In addition, there are fewer elderly people in developing countries and there is little experience in vaccinating this segment of the population. Vaccine adjuvants can be used to better treat the elderly, but their effectiveness also remains to be demonstrated. Finally, we need to ensure vaccines for minority groups who are most at risk and dense urban areas in developing countries.

Healthcare workers should be vaccinated first, says Berkeley

HN: Do you think the cost of vaccines could be a barrier?

SB: We don’t know the final price, mainly because of the unknown manufacturing and dosage. But COVID-19 vaccines are likely to be cheap. With a single-digit price, maybe double-digit for some, but under $50 a dose. Most people will be able to afford these prices. But here’s the thing: the pandemic is costing the world $375 billion a month in lost GDP. If you look at the overall costs, the vaccine bill could be as high as $75 billion. That means that an effective vaccine that would help the economy recover would pay for itself in five or six days.`

Two billion dollars for two billion doses

HN: How much funding are you looking for?

SB: The goal is to raise $2 billion to have 2 billion doses available by the end of 2021. That’s 950 million doses for COVAX AMC, 950 million doses for high- and upper-middle-income countries, and 100 million doses for humanitarian and emergency situations, to prevent some outbreaks from getting out of control. The vaccine portfolio will be actively managed and adjusted.

HN: How many countries have signed up to date?

SB: As far as COVAX is concerned, 78 countries have declared their interest in this mechanism. Some of them publicly, such as Switzerland, the European Union, South Korea, Argentina, Brazil, and Canada. Together, they represent 1.6 billion people. These countries now have until the end of August to conclude legally binding agreements. As far as the AMC is concerned, we have raised almost $600 million. This allowed our board to formally approve the mechanism on July 30.

HN: Are you sure that one of these vaccines will be effective?

SB: Between Gavi, CEPI, and the Gates Foundation, we have already identified 16 or 17 eligible vaccines. But the truth is that we do not yet know if they will be effective and safe. Preliminary data is promising. Antibodies against the spike protein, which allows the virus to enter cells, are being produced. But we don’t know how effective these antibodies will be in neutralizing the coronavirus. And there are still many questions about the right dosage, the manufacturing, among others.

HN: Are you concerned that the anti-vaccine movement will derail the public health objective of vaccination?

SB: This is a concern that exists only in the developed world. And it doesn’t help to have political leaders who don’t follow science-based recommendations. But at the end of the day, there are only a small number of people who are anti-vaccine. Probably the same number of people who would get vaccinated at all costs. The challenge is to convince everyone in between.

HN: As an epidemiologist and director of one of the world’s leading vaccination organizations, how are you coping with the pandemic period?

SB: It’s a very difficult time. I wouldn’t say I’m working 24/7, but 20 hours a day, seven days a week is probably close to reality. Our work at Gavi is critical, so we’re motivated. We had our funding summit recently. Normally, I would have had to travel all over the world for that. This time we did it online via video conferences with 42 heads of state. They committed $11 billion to our next programme.

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Seth Berkley and GAVI

Founder of the Global AIDS Vaccine Initiative (IAVI), Seth Berkley co-leads the COVAX initiative to provide equitable and effective access to future COVID-19 vaccines. Trained in medicine at Harvard and in epidemiology at the Center for Disease Control (CDC), Berkeley has been Executive Director of Gavi, the Vaccine Alliance (GAVI), since 2011. Over the past two decades, GAVI, a private-public partnership, has facilitated vaccination of more than 760 million children in developing countries, preventing more than 13 million unnecessary deaths. During the COVID-19 pandemic, Gavi provided medical equipment to health workers and supported screening initiatives.

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Health Policy Watch is partnering with Geneva Solutions, a new non-profit journalistic platform dedicated to covering Genève internationale. In the midst of the Coronavirus pandemic, a special news stream is published at heidi.news/geneva-solutions, providing insights into how the institutions and people in Geneva are responding to this crisis. The full Geneva Solutions platform and its daily newsletter will launch 24 August. Follow @genevasolutions on Twitter for the latest news updates.

Image Credits: Gavi / Frédérique Tissandie, Government ZA.

Photo Credit: Jon Osborne

A World Health Organization spokesperson on Friday said that the Organization is not well-positioned to make specific recommendations about when, where, and how travelers should be tested or quarantined for COVID-19 as countries reopen aviation, deferring the policy question to national governments.

“Some of it is really dependent on what your national authorities ask of you. WHO provides guidance to governments, but then the governments will have their own recommendations as to when you should be tested or retested, how soon before travel you need to have taken your test, etc. So some of those [questions] are not really on our plate to be able to answer,” WHO spokesperson Nyka Alexander said at live-streamed WHO Q&A on international travel.

Instead, the agency recommended travelers keep abreast of quarantine and testing policies in their countries of origin and destination countries.

“The limitations or the restrictions are changing every day because of the evolution of the outbreak,” said Carmen Dolea, head of the WHO International Health Regulations Secretariat. “People that decide to travel need to be to keep themselves abreast of all these changes… so they can plan their accordingly.”

In the early months of the global health emergency, senior WHO officials, including Drector General Dr Tedros Adhanom Ghebreyesus and Emergencies Executive Director Mike Ryn repeatedly advised countries against imposting any travel restrictions at all.  But as the virus spread across the planet, most countries took unilateral action, locking down all but essential aviation.

Now, the patchwork of traveler quarantine and testing policies emerging across countries as skies reopen has still left many people confused and sometimes in a lurch, as countries abruptly change policies without notice.  However, in the last meeting of WHO’s COVID-19 emergency committee, experts abstained from issuing any specific recommendations about how to safely resume aviation, saying only that countries should periodically review restrictions to ensure that they are well founded.

In July, the European Union sought to devise a coherent regional approach, opening travel between all countries of the EU region and compiling a “safe list” of other nations, like Canada and New Zealand, which have low levels of infection and whose nationals can also freely enter the EU.  Travelers from countries on the so-called  “green list”, which is being updated regularly,  are not required to undergo additional COVID-19 testing before or after arrival, nor are they required to quarantine.

However, as the summer wore on, it became apparent that even a spot on the safe list isn’t enough to guarantee ease of travel, as different countries that were part of the zone began to steer their own course anyway.

On July 26th, United Kingdom citizens vacationing in Spain had their return plans abruptly changed after the UK removed Spain from its “safe” country list – meanting that UK citizens returning from holidays in Spain would have to quarantine at home for two weeks upon landing.

Different Approaches To Traveler Quarantine And Testing

Other countries, such as France, are now requiring travelers from countries outside the safe list to arrive with proof of a negative COVID-19 test taken 2-3 days before arrival, take a test upon entry into France, or undergo a mandatory 2 week quarantine.

Germany has required all travelers from risk areas with more than 50 per 100,000 infections to quarantine for two weeks upon arrival, unless they have a signed doctors note indicating they have tested negative for COVID-19 in the 48 hours before landing. Germany has also announced they will be requiring travelers from risk areas to take mandatory COVID-19 tests upon arrival in the near future.

The United Kingdom has continued with its blanket two week mandatory quarantine for travelers from non-safe countries, despite pressure from the airline industry to move towards a traveler testing approach.

Heathrow Airport Chief Executive Officer John Halloway-Kane said in a letter to the UK Prime Minister that the havoc caused by the Spain flip-flop reiterates the need for the UK to embrace passenger testing.

Halloway-Kane wants the UK to take a “test upon arrival” approach. Passengers would be required to take a coronavirus test on arrival, quarantine for 8 days and then take a second test to determine whether they picked up an infection during flight.

That would at least reduce the amount of time that returning travelers have to quarantine.  But in the currently volatile atmosphere, even adding passenger testing to the equation may not diminish the changeability of travel policies. Countries make their safe entry lists based on the epidemiological situation in the country of origin. If a spike in cases in the country of origin occurs, the entry requirements for travelers can still change quickly, as was the case recently with Spain.

As a result, many governments are simply recommending that their citizens avoid traveling altogether unless it is essential. And if they do, they need to keep up with changing travel requirements as much as possible. Switzerland recommends travelers contact a country’s embassy on the day of travel to determine whether entry is still possible.

WHO also is recommending that people avoid non-essential travel, particularly for people with pre existing conditions or above the age of 65.  In a radical departure from its earlier resistance to the public wearing of face masks, WHO has now become an enthusiastic proponent of the use of masks, particularly in closed environments like planes, trains and buses, as well as stores.

And, in fact, the Organization kicked off a new #WearAMask challenge on social media channels Friday.

The campaign, designed to promote wider public use of the masks in settings where COVID-19 is a risk, asks people to promote photos of their own reusable cloth masks. Such masks should be made of three-layers of fabric, including a knit or woven cotton inner layer, a polypropolene filter layer, and a water-resistant polyester or polyester-cotton blend outer layer for optimal efficacy, and can be easily made at home.

 

Image Credits: Flickr: Jon Osborne.