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J&J, Moderna COVID-19 Booster Jabs Near FDA Authorization

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Johnson & Johnson (JNJ - Free Report) announced that the FDA’s Vaccines and Related Biological Products advisory committee (VRBPAC) unanimously voted in favor of emergency use authorization (EUA) to the booster dose of its single-shot COVID-19 vaccine for adults aged 18 and older and who have completed at least two months after the initial dose.

J&J’s EUA amendment request to include a booster dose of its COVID-19 vaccine was backed by data from several clinical studies including the phase III ENSEMBLE 2 study. Data from the ENSEMBLE 2 study showed that a booster dose given 56 days after the first jab led to 94% protection against symptomatic (moderate to severe/critical) COVID-19 in the United States and 75% protection globally. Meanwhile, the “second” or booster shot provided 100% protection against severe/critical COVID-19 — at least 14 days post-final vaccination. The booster dose increased antibody levels four to six times higher than the levels observed after the first vaccination.

Last week, Moderna’s (MRNA - Free Report) mRNA-based COVID-19 vaccine, mRNA-1273’s booster dose was also recommended by the VRBPAC for an EUA from the FDA. The advisory committee unanimously voted for emergency use of Moderna’s COVID-19 booster jab for people aged 65 years or older, and in adults aged 18 or older who at high risk of severe COVID-19 or whose exposure to COVID-19 puts them at a risk of complications or severe illness. The booster dose of mRNA-1273 will be administered to individuals who have completed the initial two-dose regimen at least six months ago.

Although the positive recommendation from the VRBPAC does not signify an FDA authorization for booster doses of J&J and Moderna’s COVID-19 vaccines, the FDA generally considers the recommendation from its advisory committee while making an approval/authorization decision. We expect the booster dose of both vaccines to be authorized and made available for administration shortly.

Shares of J&J have gained 2.5% so far this year compared with the industry’s increase of 8%.

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Moderna’s booster dose of mRNA-1273 boosted neutralizing titers significantly compared with the level achieved in the phase III COVE study. The boost in neutralizing titers was seen across all age groups, notably in the age group of 65 and above (older adults). Data from an additional analysis showed that the booster dose significantly increased geometric mean titers for all the variants of concern.

We note that the booster dose of mRNA-1273 is already authorized for use in certain immunocompromised adults.

Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) COVID-19 vaccine, Comirnaty, was the first to receive an EUA from the FDA for a booster dose last month for use in elderly and high-risk adults like healthcare workers and others. The committee recommended that the third jab should be given at least six months after the primary two-dose series.

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