Exclusive: EU drug regulator plans to accelerate variant-modified COVID vaccines


MILAN (Reuters) – The European drug regulator plans to speed up evaluations of any COVID-19 vaccine that is modified to protect against variants of the virus, the head of the agency’s COVID-19 working group told Reuters on Friday.

FILE PHOTO: Dr. Bertram Wiedenmann (R) prepares to vaccinate a patient with AstraZeneca’s COVID-19 vaccine at Berlin’s former Tegel TXL airport, amid the spread of coronavirus disease (COVID-19) in Berlin, Germany, on February 10, 2021. Kay Nietfeld / Pool via REUTERS / File Photo

Marco Cavaleri, chair of the European Medicines Agency (EMA) vaccine evaluation team, said there should be no need for large-scale, long trials like those needed to evaluate the first COVID-19 vaccines, as adjustments can be tested. for new variants. in smaller groups.

“We are working on updated guidelines, assuming that we cannot request large Phase III trials. This will allow us to go faster, ”said Cavaleri.

“We will request much smaller trials, 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 been testing their COVID-19 vaccines against several more infectious and fast-spreading variants of the novel coronavirus.

The 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) have already been widespread worldwide, increasing pressure on governments struggling to control the pandemic that has killed nearly 2.5 million people.

These are the top three 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 require one or more injections. reinforcement.

DIFFUSION

Last week, the US Food and Drug Administration also said it is considering a rapid review process for the rapid changeover of new COVID-19 booster vaccines if variants emerge against which the vaccines do not provide protection.

Vaccine makers Pfizer and BioNTech, as well as AstraZeneca and Moderna, whose COVID injections have been cleared for emergency use in Europe, have said they are preparing for the possibility of variants emerging that could require adjustments to their vaccines.

Typically, an EMA approval requires extensive studies with a large number, beginning 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 pharmacists 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 placebo clinical trials for categories such as the elderly due to the launch of current COVID-19 vaccines.

“In that case, we could think of a direct comparison with an already approved vaccine,” he said.

Cavaleri also told Reuters that Johnson & Johnson will submit its formal vaccine application in the coming days.

“Probably next week,” he said, noting that the EMA has been conducting an ongoing review of the vaccine for some time. “Mid-March is reasonable for the EMA’s decision,” he said.

The EMA, he added, has been in contact to date with about 50 pharmaceutical companies working on COVID vaccines.

Regarding the Russian vaccine Sputnik V, he said the agency is in constant contact with the company that produces it.

“There is constructive cooperation. If there are no problems 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 companies developing vaccines, in particular Sinovac Biotech, but the process for the Chinese vaccine is a few steps behind the Russian one, he said.

Reporting by Emilio Parodi, editing by Kate Kelland and Kirsten Donovan

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