European Medicines Agency rules against second COVID-19 booster jab 

Despite the EU’s vaccine rollout program being slow initially, Europe now has a high vaccination rate. So far, more than 70% of Europeans have been fully vaccinated, and over 50% have received a booster dose. 

However, the EU’s medical authority, the European Medicines Agency (EMA) has stuck to its view that additional COVID-19 boosters shouldn’t be given at this time. The agency says that there’s not enough evidence to justify a second booster dose. 

Earlier this week, the Head of the EMA’s Biological Health Threats and Vaccines Strategy team said in a statement, “You have seen statements from some vaccine developers to stress the need for a second booster shot. 

I want to reiterate that from a regulatory point of view, there is not yet enough evidence either from clinical trials or from real-world evidence supporting our recommendation on the need for a second booster shot in the general population.”

Studies have shown mixed results when it comes to second booster doses for younger adults, although for the elderly and the immunosuppressed, they have shown benefits like reduced hospitalisations and lower death rates. 

While the EMA is still collecting evidence on the best way to go forward with vaccinations, some EU countries have already started offering second booster doses to some groups, like the elderly and those with severely weakened immune systems. 

These groups are much more vulnerable than younger adults and are more likely to develop severe COVID-19. 

In Italy, extra doses are already available for immunosuppressed people, and in Hungary, anyone that has a doctor’s recommendation can get a fourth shot. 

Pfizer and BioNTech have already applied for authorisation for the fourth dose in other countries, including the US. The companies are confident that an additional dose is needed. 

The application is based on data from Israel. “Data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness,” the company says.

It continues to say that “an additional booster dose of the Pfizer-BioNTech vaccine administered at least four months after an initial booster dose could restore antibody titers to peak post-third dose titer levels, improve protection against both infection and severe disease in individuals 60 years of age and older in Israel, and have a similar safety profile to that of previous doses”.  

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