EMA Approves Expanded COVID Vaccine Manufacturing Capacity For Europe; India Interrupts COVAX Vaccine Deliveries To Low Income Countries
Medicines & Vaccines 26/03/2021 • &
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.

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