EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing bivalent COVID-19 vaccines from Pfizer/BioNTech and Moderna. The boosters target the omicron BA.1 sublineage. Assuming the European Commission follows CHMP’s recommendations, the European vaccine campaign will use bivalent vaccines targeting the original version of the omicron variant. U.S. regulators, by contrast, have backed…
FDA advisory panel to convene to consider second booster dose
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster dose. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster. Pfizer and its partner BioNTech SE (Nasdaq:BNTX)…
CDC panel recommends COVID-19 boosters for teens
CDC’s Advisory Committee on Immunization Practices (ACIP) voted almost unanimously to support the Pfizer-BioNTech COVID-19 vaccine booster for individuals aged 12 to 17. As with adults, the recommendation applies to individuals who received the second dose at least five months in the past. ACIP also recommended that the CDC bolster its suggestion that adolescents between the…
Israel plans to authorize fourth COVID-19 vaccine dose for high-risk populations
Mere months ago, health experts were divided on whether COVID-19 boosters were necessary for the broader public. Then came delta and then came omicron. Now, Israel is moving to become one of the first countries to offer a fourth dose of COVID-19 vaccine to people at least 60 years old and those at high risk…
CDC director recommends boosters for more Americans
CDC Director Dr. Rochelle P. Walensky issued guidelines for COVID-19 boosters, clearing the way for tens of millions of U.S. citizens to obtain a third dose of the Pfizer-BioNTech COVID-19 vaccine. While FDA and the Advisory Committee on Immunization Practices (ACIP) reached broadly similar conclusions regarding booster doses for seniors and high-risk individuals, Walensky went…
Single dose of Janssen’s COVID-19 vaccine offers durable protection, but a booster amplifies it
Drawing from de-identified insurance claims data, Johnson & Johnson (NYSE:JNJ) has announced that a single dose of its Ad26.COV2.S vaccine was 79% effective in preventing COVID-19 infections and is 81% effective in preventing hospitalizations associated with the novel coronavirus. The company also released results from its Phase 3 ENSEMBLE 2 trial, which tested the impact…
U.S. could recommend COVID-19 boosters at five months, according to Biden
Facing the second-largest COVID-19 wave to date, U.S. regulators are mulling providing boosters three months earlier than initially anticipated. People who are fully vaccinated would be eligible for a booster dose five months after receiving the second dose, Biden said, noting that the plan was still tentative. On Aug. 18, U.S. Surgeon General Vivek Murthy…