Infectious Disease

Pfizer-BioNTech seek EUA for fourth dose of COVID-19 vaccine for older adults

March 17, 2022

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Please see the studies for all other authors’ relevant financial disclosures.

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Pfizer and BioNTech announced this week that they are seeking an emergency use authorization from the FDA for an additional booster dose of their COVID-19 vaccine for older adults.

The companies have submitted an application for the EUA for adults aged 65 years or older who have already received a booster dose of any authorized COVID-19 vaccine.

IDN0322Pfizer_FourthDose

Their submission was based on data from Israel that showed an additional dose of the vaccine increases immunogenicity, lowers rates of confirmed infections and lowers rates of severe illness, according to a press release.

One analysis by the Israeli Ministry of Health of more than 1.1 million adults aged 60 years or older with no history of COVID-19 demonstrated a decreased rate of infection and severe illness after a second booster. Rates of confirmed infections were two times lower and rates of severe illness were four times lower among people who received the extra shot at least 4 months after a third dose compared to those who received only one booster dose.

An ongoing trial assessing health care workers aged 18 years or older who had received three doses of the vaccine demonstrated that a fourth dose was safe and boosted antibody levels similarly to levels observed after a third dose, although the companies noted that it did not appear any more effective at preventing infection with the omicron variant. The results were published in The New England Journal of Medicine on Wednesday.

According to the companies, neither study generated any new safety concerns.

References:

Regev-Yochay G, et al. N Engl J Med. 2022;doi:10.1056/NEJMc2202542.

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Amesh A. Adalja, MD

Amesh A. Adalia

In older or high-risk individuals, fourth doses appear beneficial at preventing severe disease. I do not think younger age groups — apart from those with high-risk conditions — benefit much from even third doses. I believe the goal with a virus like this and the vaccines we have should be to prevent severe disease and targeted — not blanket, one-size-fits-all — booster polices are how to achieve it.

I do not think continual boosting is a viable strategy and we must become clear on the goals — it’s not eradication or elimination, but reduction of severe disease. For most people, two shots of the mRNA vaccines are sufficient to protect against severe disease. For the high risk, boosting and Evusheld are necessary.

Amesh A. Adalja, MD

Senior scholar

Johns Hopkins Center for Health Security

Disclosures: Adalja reports no relevant financial disclosures.

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