European Medicines Agency and FDA seek an aligned strategy against COVID-19

SARS-CoV-2 will continue to mutate, and at a faster rate if the vaccines do not reach all corners of the planet, although it may one day become endemic.

Faced with an uncertain future, drug agencies are mobilized to seek “long-term” joint strategies, to the detriment of “continuous” reinforcements and “reactive” responses.

In the coming days, the conclusions of a meeting between regulators from around the world, which was co-chaired on Wednesday by the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA), in which everyone discussed what the global regulatory response to the virus should be.

Participants, including experts from the World Health Organization (WHO) and the European Commission, reviewed the available evidence on the effectiveness of vaccines against the omicron variant, seeking “an alignment of key regulatory requirements to support the development of a possible vaccine adapted” to this variant.

Experts from South African and Israeli drug regulators also shared their views at the meeting.

“This is not just about the regulatory response to omicron, but also about setting the stage for a more strategic discussion about what types of vaccines might be needed in the long term to adequately manage COVID-19,” he noted the day before (Thursday) EMA Director General Emer Cooke.

But these decisions, he emphasized, are not just a matter for drug regulators, but rather “the collaboration of all actors in this space” is needed, including those responsible for decision-making in public health at the national level, regional and global.

The emerging data so far regarding the spread of omicron suggests two things: vaccines are losing effectiveness in protecting against contagion and mild COVID-19, but still provide high protection against developing severe disease, death and hospitalization due to COVID-19.

European citizens are now receiving booster doses with the same composition approved since December 2020, and it has not yet been confirmed that it is necessary to modify the vaccines available against COVID-19 in the European Union (Pfizer-BioNTech, Moderna, AstraZeneca and Janssen), but the EMA already has a defined protocol in case of need.

“When looking at the regulatory requirements for any vaccine variant, there was broad agreement that clinical data is needed to approve a new updated vaccine,” the EMA noted.

The agency could take “three or four months” to approve an adapted vaccine, which could arrive “at least in April or May” depending on the clinical studies carried out with the new preparation, confirmed Marco Cavaleri, head of Vaccination Strategy. .

But it’s also not “yet obvious that a purely omicron-adapted vaccine is the best strategy, especially if we look long-term this year or next,” he warned.

For the EMA, it is important that there is a dialogue about the choice of the composition of the vaccine, to ensure that there is a strategy that is not only reactive after changes in the virus, but also tries to anticipate what the next move will be and devise a proper approach to prevent future variants that will emerge anyway, says Cavaleri.

The EMA insists that “we have to think about how we can move from the current and still pandemic framework, to a more endemic one”, which – still unconfirmed – could be the scenario towards which COVID-19 could potentially walk in the future.

One of the strategies is to “synchronize vaccination with the arrival of the (cold) season depending on the hemisphere, similar to what already happens with the flu vaccine” in the fall, says Cavaleri, in defense of a vaccination ” more spaced out in time.

“If we have a strategy where we give boosters every, say, four months, we will probably end up having problems with the immune response, which will not be as good as we would like. So we should be careful not to overload the immune system with repeated immunization,” he summarized this week.

While that strategy is being pursued, the EMA urges you to take the potential hospital burden of omicron seriously and not relax because preliminary data shows it could cause mild COVID-19. “We cannot forget that we are still in a pandemic,” concluded Cavaleri.