By Francesco Guarascio and Emilio Parodi

BRUSSELS (Reuters) – The EU’s drugs regulator will decide on Monday whether to approve Pfizer (NYSE:)’s COVID-19 booster vaccine, but it is unlikely to give precise guidance on who should receive it, according to an internal document and two officials.

If the European Medicines Agency gives its support for the jab the 27 member bloc would be joining the United States of America, Britain, and Israel that have all received approval to use boosters even though scientists are not unanimous.

According to Reuters minutes, Emer Cooke from EMA stated that the EMA would issue an opinion regarding the necessity of Pfizer boosters in the general population on October 4.

EMA did not respond to requests for comment.

Although EMA had publicly stated that it would make a decision on Pfizer’s booster in October, the date has not been given.

Without official EMA support, boosters have been administered in more than a dozen EU nations.

The official approval of these countries will give them legal protection and could encourage others to create a booster program for the less contagious Delta variant in the winter months.

According to two EU officials who are familiar with EMA decision-making processes, the decision next week will concentrate on booster safety and effectiveness. It will also be wide in scope and not specify which risk group or age should get it.

It would also be consistent with EMA’s earlier decisions about vaccine boosters to other diseases like tetanus.

It would be in line with EMA’s prior decisions on the pandemic. It left it to members states to make the decision whether to reduce vaccines or restrict them in light of possible side effects.

This guidance would enable states to adapt the use and dosage of boosters to meet their own needs. Without having to go beyond what EMA has authorized, which could increase legal risks.

The EMA stated in August that there wasn’t enough evidence to recommend boosters. In response, the World Health Organization demanded a halting of boosters until the vaccinations have been completed.

According to the minutes from Tuesday’s meeting, Cooke stated that boosters are not needed for general populations, but that there was a waning effect for elderly people.

Wide guidance may increase differences between EU countries. The region’s rules for who gets boosters are already highly fragmented. Authorities in Austria, Hungary, and the Czech Republic are pushing for a wider roll-out, while other countries only allow those who are most vulnerable to receive boosters.

The EU Commission repeatedly warns that different policies in national vaccine policies can lead to increased hesitancy.

The broad approach taken by the EMA differs from those of major Western nations.

Last week, the U.S. Food and Drug Administration recommended Pfizer boosters for people 65 and over, those at risk of serious disease and other individuals who have been exposed frequently to the virus.

Boosters are now being administered in the United Kingdom to adults over 50, health workers and anyone who is at risk of contracting COVID-19.

MANY SPARE DOSES

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

EU countries have purchased booster vaccines.

The EU states agreed to purchase at most 900 million doses each of BioNTech or Pfizer’s vaccines in May. After the EU had secured enough shots from Pfizer or other vaccine manufacturers, this agreement was made in May.

The contract requires the EU to purchase the nearly 900,000,000 shots mainly from next year and may order an additional 900 million by 2023.

The majority of additional Pfizer shots would be used to boost vaccination rates since 75%+ of EU adult population is already fully vaccinated.

They could be donated or sold to those in need. You could use some of these vaccines against future variants or to treat children with them. Pfizer will sell EU-modified shots, if necessary.

Two people who are familiar with the matter told Reuters that Pfizer cannot force Pfizer into providing an updated version. However, the process of deciding when a new vaccine will be effective and when it may become predominant is complex.

Pfizer declined to comment about the EU agreement, however Albert Bourla (the company boss) said that the company can produce updated COVID-19 vaccinations within 100 days.