MILAN (Reuters) – European drug regulator plans to accelerate reviews of COVID-19 vaccines modified to protect against variants of the virus, head of the agency’s COVID-19 task force told Friday to Reuters.
Marco Cavaleri, chair of the vaccine evaluation team at the European Medicines Agency (EMA), said there should be no need for long-term large-scale studies such as those needed to evaluate the first COVID-19 vaccines, as adaptations for new variants can be tested on smaller groups.
“We are working on updated guidelines, assuming we cannot request large Phase III trials. This allows us to go faster, ”said Cavaleri.
“We will call for much smaller studies, with a few hundred participants, instead of 30,000 to 40,000,” he told Reuters. He said the EMA would focus primarily on immune response data.
Drug makers, including Pfizer, Moderna and AstraZeneca, have tested their COVID-19 vaccines against several fast-spreading, more contagious variants of the new coronavirus.
Variants that emerged in Brazil (known as P.1.), Great Britain (known as 20I / 501Y.V1 or B.1.1.7) and South Africa (known as 20I / 501Y.V2 or B.1.351) are already spread around the world, putting more pressure on governments struggling to curb the pandemic that killed nearly 2.5 million people.
These are the three main variants that concern scientists, as their distribution increases the risk that newly developed COVID-19 vaccines will need to be updated or modified to be effective against some variants, and that people may need one or more booster shots.
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Last week, the U.S. Food and Drug Administration also said it is considering a rapid review process for the rapid turnaround time of new COVID-19 booster shots if variants emerge that the vaccines do not protect against.
Vaccine manufacturers Pfizer and BioNTech, as well as AstraZeneca and Moderna, whose COVID injections are approved for emergency use in Europe, have said they are preparing for the possibility that variants will emerge that may require modifications to their vaccines.
Normally, an EMA approval requires extensive, high-volume studies, starting with safety and ending with efficacy.
“We will also try to streamline regulatory procedures by doing something similar to what happens with flu vaccines. In short, without the drug manufacturers having to resubmit all the preliminary data, ”said Cavaleri.
He added that the EMA is also aware that in the near future it may no longer be possible to conduct clinical trials of placebo for categories such as the elderly, due to the roll-out of the current COVID-19 vaccines.
“In that case, we could consider a direct comparison with an already approved vaccine,” he said.
Cavaleri also told Reuters that Johnson & Johnson will be filing a formal application for a vaccine in the coming days.
“Probably next week,” he said, noting that the EMA has been reviewing the vaccine for a while. “Mid-March is reasonable for the EMA’s decision,” he said.
The EMA, he added, has so far been in contact with about 50 pharmaceutical companies working on COVID vaccines.
Regarding the Russian vaccine against Sputnik V, he said the agency is in constant contact with the company that produces it.
“There is constructive collaboration. If there are no issues with the answers we get in terms of the production phase, the ongoing evaluation can begin within weeks, “he said.
The EMA is also in contact with the Chinese vaccine development companies, particularly Sinovac Biotech, but the process for the Chinese vaccine is a few steps behind Russia’s, he said.
Reporting by Emilio Parodi, edited by Kate Kelland and Kirsten Donovan