ニュース

【ワシントンAFP=時事】米食品医薬品局(FDA)は20日、新型コロナウイルスワクチンの追加接種を65歳以上、または深刻な基礎疾患がある人に制限する方針を示した。65歳未満で基礎疾患のない個人に関しては、ワクチンを製造する製薬会社に新たな臨床試験の実 ...
健康な成人と子どもを対象とした新型コロナウイルス感染症のブースター接種について、米規制当局は今後、新たな臨床試験で安全性と有効性が確認されることを承認の条件とする。コストのかかる新要件が追加され、将来的にはワクチン接種対象者が絞られる可能性もある。
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded ...
The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at ...
The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...
Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which ...
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
The shift was a marked departure from previous FDA guidance, which recommended an annual COVID vaccine for everyone 6 months ...
For groups younger than 65 or without specific chronic conditions, postmarketing trials will be needed to open access.
The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the ...
The FDA will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...
In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people ...