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FDA Authorizes Pfizer, Moderna's Second COVID Booster Dose

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On Tuesday, the FDA authorized a second booster dose of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) mRNA-based COVID-19 vaccines for older adults and some immunocompromised people.

Moderna’s shares rose 4.4% on Tuesday, while BioNTech’s stock was up 3.6% in response to this positive development. Pfizer was down slightly.

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. Only the Pfizer/BioNTech vaccine is authorized for those as young as 12.

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 had applied to the FDA earlier this month to amend their existing Emergency Use Authorization (EUA) to allow an additional or the “fourth” booster dose of their COVID-19 vaccine. While Pfizer applied for authorization in adults 65 years of age and older, Moderna filed for authorization for all adults aged 18 years and above.

Pfizer and BioNTech and Moderna’s applications were based on safety and efficacy data from real-world studies from Israel when the Omicron variant was widely prevalent. Pfizer/BioNTech said that data from these studies showed that in individuals who were given the fourth shot, the rates of infections were two times lower and rates of severe illness were four times lesser compared to those who only received the third booster shot.

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.

For individuals to be adequately protected, additional booster doses of COVID vaccines are needed as the immunity offered by the third dose eventually fades three to six months after receiving it.

The emergence of BA.2, an Omicron subvariant, in the United States and Europe has triggered fresh concerns of a possible new wave of infections and created a situation of uncertainty. There is not much evidence to show how much benefit the additional booster will give. However, if cases rise later in the year, an additional booster should protect these older adults who are at most risk of severe illness.

Approval of additional booster shots will increase sales for Moderna and BioNTech as both these companies have only one marketed product — their COVID-19 vaccines. Their stocks have declined this year in anticipation that with the pandemic potentially entering the endemic stage, their sales would fall from 2023 onward.

Pfizer, Moderna and BioNTech have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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