Tuesday, 30 November, 2021
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European Medicines Agency approves Pfizer booster for 18-years and older

The European Medicines Agency has approved the administering of booster shots of the Pfizer-BioNTech COVID-19 vaccine for people 18 and older.

The EMA said the booster doses “may be considered at least six months after the second dose for people aged 18 years and older”.

AP News reports that the agencyʼs human medicines committee issued the recommendation after studying data for the Pfizer vaccine that showed a rise in antibody levels following boosters given at about six months after the second dose, in people from 18 to 55.

The agency also supports a third dose of either the Pfizer-BioNTech or Moderna vaccine to people with severely weakened immune systems at least 28 days after their second shot: this decision followed studies showed that a booster jab increased peopleʼs ability to produce antibodies against the virus that causes COVID-19 in organ transplant patients with weakened immune systems.

“Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients,” the agency said in a statement.

AP said the EMA recommendations go to the European Commission for approval and then to health authorities in all 27 EU nations, whose national health authorities decide on vaccination strategies. Some countries already have begun administering booster shots.

Numerous studies have shown that the Pfizer-BioNTech and Moderna vaccines remain strongly protective months after people receive their second dose, dramatically cutting the risk of hospitalisation and death.

The World Health Organizationʼs chief had urged wealthy nations not to use booster doses this year, saying there is no scientific data proving them necessary, and that COVID-19 vaccines would be put to better use in developing countries, where many people still have not received their first jabs.

The United States government launched a campaign last month to offer boosters of Pfizerʼs COVID-19 vaccine to millions of Americans even as federal health officials stressed the real problem remains getting first shots to the unvaccinated.

Pfizer-BioNTech said in a statement it doesn’t “expect the introduction of booster doses in the US and EU, if authorised, to impact the existing supply agreements in place with governments and international health organisations around the world”.

The coronavirus pandemic has killed at least 4.8 million people around the world, adds AP.

 

AP News article – EU regulator OKs Pfizer vaccine booster for 18 and older (Open access)

 

See more from MedicalBrief archives:

 

CDC panel backs third Pfizer and Moderna shot for the immunocompromised

 

WHO’s vaccine head on why the rush for COVID booster jabs is premature

 

100m COVID vaccines will expire in rich countries by Christmas

 

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