FDAは、追加接種の有効性に関するデータが不十分であることと、ワクチン接種の推奨に対する国民の信頼が低下していることを理由に、来シーズンのCOVID-19ワクチンの承認に対するアプローチを再検討している。 FDA長官のマーティ・マカリー博士は、新たな ...

Leaders at the FDA, HHS and elsewhere are putting guardrails around COVID-19 boosters, which could mean delayed shots or ...

Overall, the hazard ratio for in-hospital mortality at 28 days was 0.73 (95% confidence interval, 0.56 to 0.96) compared to ...

Vinay Prasad, named to lead the FDA agency tasked with regulating vaccines and gene therapy, has made controversial comments ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

The head of the U.S. Food and Drug Administration on Tuesday reportedly raised doubts about the need for COVID booster shots ...

While incidence of community-associated and healthcare-associated community-onset MRSA bacteremia declined during the ...

Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.

Novavax said on Thursday discussions with the U.S. health regulator on its COVID-19 shot are ongoing and a pathway to ...

His answer marks a change from during the Biden administration, when FDA officials backed plans to routinely update the COVID-19 vaccines each year. Last year, the FDA issued guidance on what ...

The new FDA vaccine chief, Dr. Vinay Prasad was an outspoken critic of the agency's response to the pandemic, including the ...

Meanwhile, health secretary Robert F. Kennedy Jr. and his lieutenants have sent multiple signals in recent weeks that they ...