EXCLUSIVE EU to decide on Pfizer booster on October 4 – document

BRUSSELS, September 29 (Reuters) – The European medicines regulator will decide on Monday whether or not to approve Pfizer’s COVID-19 booster vaccine (PFE.N), but it is unlikely to give precise indications on who should receive it, according to an internal document and two officials.

If the European Medicines Agency (EMA) gives its backing to the jab, the 27-member bloc would join the United States, Britain and Israel who have already been given the green light to deploy boosters, even if they do not There is no consensus among scientists that they are needed.

“On October 4, the EMA will issue an opinion on the need for Pfizer boosters for the general population,” EMA chief Emer Cooke told EU lawmakers at an internal meeting on Tuesday, according to the account. rendering of the discussion viewed by Reuters.

The EMA was not immediately available for comment.

The EMA publicly announced that it would decide to recall Pfizer in early October, but never gave a specific date.

More than a dozen EU countries have already started administering boosters without official EMA support. Read more

The official approval will provide legal protection for those countries and may prompt others to launch a recall program to tackle the more infectious Delta variant during the winter months.

Two EU officials familiar with EMA decision-making processes said next week’s decision will focus on the safety and effectiveness of the recall, and will be broad in scope, meaning it won’t will not accurately state the age or risk groups that should receive it.

This would be in line with EMA decisions on vaccine recalls for other diseases, such as tetanus.

The approach would also be consistent with previous EMA decisions during the pandemic – for example, it largely left it up to member states to decide whether to restrict vaccines in the face of potential side effects. Read more

The general guidance would allow states to tailor the use of boosters to their national needs, without risking administering them beyond instructions authorized by the EMA – which would increase their legal risks.

In August, the EMA said there was not enough data to recommend the use of boosters, and the World Health Organization called for the boosters to be stopped until more people around the world have been vaccinated. Read more

“There is no need for boosters for the general population, but there is a diminishing effect, especially for the elderly,” Cooke told EU lawmakers, according to the minutes of Tuesday’s internal meeting. .

The broad guidelines could amplify the differences between EU states. Who gets a recall in the area is already fragmented. In Austria, Hungary and the Czech Republic, authorities are aiming for a wider deployment, while in other states only certain more vulnerable people would benefit from recalls. Read more

The European Commission has repeatedly warned that different national vaccine policies can increase hesitation.

The broad approach of the EMA would also be different from that of other major Western countries.

The United States Food and Drug Administration (FDA) last week recommended the Pfizer recall for people 65 years of age and older, all people at high risk for serious illness, and others regularly exposed to the virus.

In the UK, boosters are given to all adults aged 50 and over, healthcare workers and anyone at high risk of COVID-19 or in close contact with people with compromised immune systems Read more.

MANY REPLACEMENT DOSES

Scientists are divided over whether boosters are needed, as it is not yet clear how long the protection lasts in people who have been fully vaccinated, the European Center for Disease Prevention and Control (ECDC) said. .

However, EU states have already purchased additional booster vaccines.

They agreed in May to purchase at least 900 million doses of the vaccine from Pfizer and BioNTech (22UAy.DE). This came after the EU had already obtained more than enough vaccines for its entire population from Pfizer and other vaccine makers.

Under the contract, EU governments are required to purchase the 900 million snapshots, mostly from next year, and could order another 900 million until 2023.

Since almost 75% of the adult EU population has already been fully vaccinated, most additional doses of Pfizer would likely only be needed if given as a booster.

An alternative would be to give them away or sell them to the poorest nations who do not yet have enough doses. Some of the vaccines could also be deployed on children or be used against potential new variants. Pfizer has agreed to sell the modified EU snapshots if necessary.

But the decision of when a new variant may be predominant and whether the existing vaccine is not effective against it requires a complex procedure that makes it difficult to force Pfizer to provide an updated version, two people familiar with the drug told Reuters. the contract.

Pfizer has not commented on the contract with the EU, but company boss Albert Bourla has said he can develop updated versions of his COVID-19 vaccine in less than 100 days, if new variants appeared.

Report by Francesco Guarascio @fraguarascio and Emilio Parodi; Editing by Josephine Mason, Elaine Hardcastle

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