Brussels will shorten deadlines to authorize vaccines against new strains of Covid-19

Von der Leyen casts doubt on Sputnik: “How can they offer millions of doses to the EU and not vaccinate in Russia?”

President Ursula von der Leyen, during the press conference this Wednesday

The appearance and multiplication of new highly contagious variants Covid-19, like the British or South African, has become the main cause of concern for the European Union in the third wave of the pandemic. Especially for the risk that these strains are resistant to already licensed vaccines, whose deployment is proceeding at a much slower rate than anticipated due to the general shortage of doses.

For all these reasons, the President of the Commission, Ursula von der Leyen, has launched this Wednesday a preparedness plan against the threat of coronavirus mutations. An initiative that also serves to respond to the criticism of the capitals and the European Parliament against her for the setbacks in the vaccination strategy. And also to correct some of the errors that the president herself has recognized.

The main novelty of the plan is that the Community Executive will present in the coming weeks a legislative proposal to speed up approval times for tailored antigens to the new variants. The European Medicines Agency (EMA) has received multiple criticism for its delay in approving vaccines against Covid-19 compared to the United Kingdom or the United States.

The headquarters of the European Medicines Agency (EMA) in Amsterdam

The headquarters of the European Medicines Agency (EMA) in Amsterdam

Von der Leyen has defended that the three or four extra weeks that the EMA has taken are “an essential investment in confidence and security“. At the same time, he announces that from now on the EU will go faster. His argument is that now the vaccines against Covid-19 are already known, so the EMA will be able to approve any adaptation based on a lower volume of supplementary data. However, it has not clarified what new deadlines are being handled.

In any case, the European Medicines Agency will send laboratories a series of guidelines on the data requirements for new vaccine versions, so that they know in advance the applicable criteria. The certification of new or adapted plants will also be facilitated. Finally, Brussels is considering creating a new procedure for the emergency authorization of vaccines, in which the Member States would assume shared responsibility.

The doubts about Sputnik

Von der Leyen has taken advantage of the press conference to present the plan to sow doubts about the Russian vaccine Sputnik V, which some Member States (in particular Hungary) see as a solution to the current shortage of vaccines in the EU. The president stressed that the manufacturer still has not submitted an authorization request to the EMA: the Budapest Government has approved it at its own risk and expense.

“If they send the request, they have to present an entire data set and pass the entire scrutiny process, like any other vaccine “, has related Von der Leyen. The other great difficulty for the Russian vaccine to be used in the EU is that “they are not producing in Europe.” “There should be an inspection procedure in the manufacturing plants, because one of the crucial points is to have a stable, high-quality production process.”

Why the European Union will not use the Russian Sputnik vaccine

Why the European Union will not use the Russian Sputnik vaccine

But also, the community Executive it is not clear that the doses that Sputnik promises exist or can be manufactured in the short term, which is when they would be needed. “Overall, I have to say that we still wonder why Russia is theoretically offering millions and millions of doses while they are not making sufficient progress in vaccinating their own population. This is also a question that I think needs to be answered ”, said the president.

Detect mutations

The second pillar of Von der Leyen’s plan against mutations is to detect, analyze and evaluate new variants. Brussels will allocate 75 million euros to have specialized tests and support genomic sequencing in Member States. The goal is to sequence at least 5% of positive tests in order to identify new strains, monitor their spread, and examine their impact on transmissibility.

In addition, the Commission has set aside a further € 150 million for enhance research and data sharing on mutations. To do this, a network of clinical trials on Covid-19 will be launched, in which 16 Member States and five associated countries have already shown interest, including Israel and Switzerland.

The third pillar aims to accelerate the production of vaccines against Covid-19 in the EU. Brussels intends to close new advance purchase contracts with laboratories or update existing ones to support the adaptation of vaccines to new variants. Something that has already been done with the new contracts signed with Pfizer-BioNTech and Moderna.

Ursula von der Leyen and Thierry Breton, during the press conference this Wednesday

Ursula von der Leyen and Thierry Breton, during the press conference this Wednesday
Etienne Ansotte / CE

In addition, Von der Leyen has created a working group led by the Commissioner for the Internal Market, the French Thierry breton, whose objective is to collaborate with manufacturers to help them solve bottlenecks in the manufacturing process.

Breton has assured that AstraZeneca, which has cut its supply to the EU in the first quarter from 100 to 40 million doses, has already improved the performance of its plant in Belgium by 50%, which he blamed for the delays. But it has not yet been clarified how many doses this laboratory will be able to deliver in the coming months.