MILAN (Reuters) – The European Medicines Authority intends to speed up the evaluation of any COVID-19 vaccines modified to protect against variants of the virus, the head of the COVID-19 working group for the Reuters agency said on Friday.
Marco Cavaleri, chairman 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 changes to the new can be tested on smaller groups.
“We are working on updated guidelines, assuming that we cannot request large phase III studies. This will allow us to go faster “, said Cavaleri.
“We will ask for much smaller tests, with a few hundred participants, rather than 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 tested their COVID-19 vaccines against several more rapid, more infectious variants of the new coronavirus.
Variants in Brazil (known as P.1.), The United Kingdom (known as 20I / 501Y.V1 or B.1.1.7) and South Africa (known as 20I / 501Y.V2 or B .1,351) have already spread around the world, putting more pressure on governments struggling to tame the pandemic that has killed nearly 2.5 million people.
These are the three major variants that concern scientists, their spread increasing the risk that the newly developed COVID-19 vaccines will be updated or modified to be effective against some variants and that people may need one or more booster shots.
STREAMLINING
Last week, the US Food and Drug Administration said it was considering a rapid review process to quickly change the new COVID-19 booster photos if variants against which vaccines do not provide protection appear.
Vaccine manufacturers Pfizer and BioNTech, as well as AstraZeneca and Moderna, whose COVID photos have been authorized for emergency use in Europe, said they were preparing for the possibility of variants that could require changes to their vaccines.
Normally, an EMA approval requires extensive studies with a large number, starting with safety and ending with effectiveness.
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 transmit all the preliminary data again “, said Cavaleri.
He added that the EMA is also aware that in the near future it may not be possible to conduct placebo clinical trials for categories such as the elderly due to the launch of the current COVID-19 vaccines.
“In this case, we could think of a head-to-head comparison with an already approved vaccine,” he said.
Cavaleri also said that Reuters Johnson & Johnson will submit the formal application for vaccination in the coming days.
“Probably as early as 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 COVID vaccines.
Regarding the Sputnik V vaccine in Russia, he said that the agency is in constant contact with the company that produces it.
“There is constructive cooperation. If there are no problems with the answers we receive about the production phase, the ongoing review could begin in a few weeks, ”he said.
The EMA is also in contact with Chinese vaccine companies, especially Sinovac Biotech, but the Chinese vaccine process is a few steps behind the Russian one, he said.
Reported by Emilio Parodi, edited by Kate Kelland and Kirsten Donovan