EU drug regulator decides Pfizer vaccine booster in early October


The European Medicines Agency (EMA) aims to decide in early October whether to approve a third dose of the Pfizer-BioNTech COVID-19 vaccine six months after the first two-shot course. review.

“Unless supplementary information is needed, the results of this assessment are expected in early October,” Marco Cavaleri, EMA’s chief vaccine strategy officer, said at a press conference Thursday.

The Cavaleri statement confirmed Reuters’ report on the EMA’s expected review time on this issue earlier in the day.

The U.S. Food and Drug Administration issued a third dose of Pfizer on Wednesday to people over the age of 65, all at high risk for serious illness, and others who are regularly exposed to the coronavirus. Approved.

EU regulators said on September 6 that they began evaluating data submitted by Pfizer and BioNTech for additional doses to people 16 years and older six months after the second dose.

According to EU documents, Moderna will submit data on the booster effect to the EMA this month.

The EMA added that at the latest in early October, already a month after the first two-shot regimen, it would end a review of the use of both Pfizer-BioNTech and Moderna shots in people with weakened immune systems.

“There is growing evidence that this option should be considered for people who are less responsive to COVID-19 vaccination, such as those with immunodeficiency,” said Cavaleri.

In an opinion issued in early September and reissued by the EMA, the European Center for Disease Prevention and Control (ECDC) stated that there was no urgent need to administer booster immunity to fully vaccinated populations. rice field.

However, many EU member states have already decided to administer booster doses without a formal decision by the EMA, despite facing higher legal risks.

Thursday’s EMA acknowledged that doing so might be beneficial.

“With the increasing number of breakthrough cases seen over time, we understand that member states in Europe and other countries want to consider booster options, especially in vulnerable groups. That’s why we’re speeding up reviews, “said Cavaleri.

He added that Pfizer and BioNTech expect to submit data on vaccine use in children aged 5 to 11 years in early October, and similar data from Modana in early November.

Regarding CureVac’s request for vaccine approval, EMA officials said Watchdog should be “in a better position to really understand what the next step for this vaccine is” by the end of the year. June and July CureVac released disappointing test data.

The EU has signed three contracts with Pfizer and BioNTech for a total of 2.4 billion doses.

The latest contract covers a supply of at least 900 million shots, most of which is only needed if boosters are considered necessary or if new viral variants emerge that are ineffective with existing vaccinations. May become.

Over 70% of the EU’s adult population is already fully vaccinated and the block ensures adequate vaccine supply from several manufacturers.

The ECDC states that there is still a lack of important data on booster needs and safety. This is because the period of time the vaccine protects against the virus is not yet completely clear.

Emilio Parody, Francesco Guaracio, Pushkara Alipaca, Ludwig Berger