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EU Agencies Doubtful About Need for 2nd COVID Booster

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On Wednesday, European health agencies said it was too early to decide whether to allow the use of a fourth dose or a “second booster” dose of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) mRNA-based COVID-19 vaccines, Comirnaty and Spikevax, in the general population in Europe.

The European Centre for Disease Prevention and Control and EMA’s COVID-19 task force, however, did agree that a fourth dose of these vaccines may be given to adults 80 years of age and above.

However, these agencies said that there was no evidence suggesting that the vaccines' protection against severe disease eventually fades in healthy adults 60 to 79 years of age with normal immune systems. Accordingly, it was not clear if there was an immediate need for a fourth booster for this population.

Nonetheless, if the present situation changes for the worse in Europe, the health agencies may consider allowing a fourth dose for the older adult population.

For adults below 60, there is also no evidence to suggest that protection afforded by vaccines against severe disease is waning, leading to a need to provide a second booster shot.

The first booster dose or “third” dose of Comirnaty and Spikevax are currently authorized for adults 18 years of age and older in the EU.

COVID infection rates have been rising in several European countries from early March due to the Omicron variant and probably BA.2, an Omicron subvariant, after curbs were lifted. However, there is not much evidence to show that a fourth COVID shot can restore protection against severe disease. It has also been argued that repeated booster doses may not be a practical or a sustainable global strategy, especially when there are several unvaccinated people in low-income nations.

A second booster dose of Pfizer/BioNTech and Moderna’s mRNA-based COVID-19 vaccines was authorized by the FDA late last month for older adults and some immunocompromised people.

The second booster dose of Pfizer/BioNTech and Moderna’s vaccine can be given to people 50 years of age and older at least four months after they have taken the first booster dose of any authorized or approved COVID-19 vaccine.

Additionally, the FDA authorized a second booster dose of Pfizer/BioNTech’s vaccine for certain immunocompromised individuals 12 years and older and Moderna’s vaccine for individuals 18 years of age and older with the same certain kinds of immunocompromise.

The FDA said that emerging evidence showed that additional booster doses of mRNA-based COVID-19 vaccines improved protection levels and were also quite safe.

Pfizer/BioNTech and Moderna’s first booster doses were granted EUA for all adults 18 years of age and older in November 2021. Later, Pfizer’s EUA was extended to allow its use in individuals 16 and 17 years of age and thereafter in adolescents 12 to 15 years of age.


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