MILAN (Reuters) – European drug regulator plans to speed up evaluations of any COVID-19 vaccine that is modified to protect it against virus variants, the head of the agency’s COVID-19 working group said on Friday and Reuters.
Marco Cavaleri, chairman of the vaccine evaluation team of the European Medicines Agency (EMA), said that long-scale trials such as those needed to evaluate the first COVID-19 vaccines should not be necessary, since that modifications of new variants can be tested in smaller groups.
“We are working on updated guidelines, assuming we can’t ask for big phase III trials. That will allow us to go faster,” Cavaleri said.
“We will ask for much smaller tests, with a few hundred participants, instead of 30,000 to 40,000,” he told Reuters. He said the EMA will focus primarily on immune response data.
Drug manufacturers, including Pfizer, Moderna and AstraZeneca, have been testing their vaccines against COVID-19 against several more contagious and rapidly spreading variants of the new coronavirus.
Variants that emerged in Brazil (known as P.1.), In Britain (known as 20I / 501Y.V1 or B.1.1.7) and in South Africa (known as 20I / 501Y.V2 or B.1.351) have already spread around the world, accumulating more pressure on governments struggling to domesticate the pandemic that has killed nearly 2.5 million people.
These are the three main variants that scientists are concerned about, as their spread increases the risk that newly developed COVID-19 vaccines will need to be updated or adjusted to be effective against some variants and that people may need a or more booster shots.
COURSE TRAINING
Last week, the U.S. Food and Drug Administration also said it is studying a rapid review process for the rapid modification of new COVID-19 booster shots if variants appear against which vaccines do not offer protection.
Vaccine manufacturers Pfizer and BioNTech, as well as AstraZeneca and Moderna, whose COVID features have been authorized for emergency use in Europe, have said they are preparing for the possibility of variants appearing that may require modifications to their vaccines.
Typically, an EMA approval requires extensive studies in large numbers, 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. Ultimately, without pharmacists having to re-submit all preliminary data,” Cavaleri said.
He added that the EMA is also aware that in the near future it may no longer be possible to conduct clinical trials with placebo for categories such as the elderly, due to the launch of current COVID-19 vaccines.
“In this case, we could think of a face-to-face comparison with an already approved vaccine,” he said.
Cavaleri also told Reuters that Johnson & Johnson will file its formal vaccine application in the coming days.
“Probably already next week,” he said, noting that the EMA has been conducting a continuous review of the vaccine for some time. “In mid-March it is reasonable for the EMA decision,” he said.
The EMA, he added, has so far been in contact with about 50 pharmaceutical companies working on vaccines against COVID.
Regarding the Sputnik V vaccine in Russia, he said the agency is in constant contact with the company that produces it.
“There is constructive cooperation. If there are no issues with the responses we receive on the issue of the production phase, the ongoing review could begin in a matter of weeks, ”he said.
The EMA is also in contact with Chinese vaccine companies, particularly Sinovac Biotech, but the process for the Chinese vaccine is a few steps away from the Russian one, he said.
Report by Emilio Parodi, edited by Kate Kelland and Kirsten Donovan