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Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11


07 Oct 2021

WASHINGTON — Pfizer and BioNTech said on Thursday morning that they had asked federal regulators to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States.


The Latest on COVID-19 Boosters


28 Sep 2021

More than 180 million Americans, including more than 80 percent of people over age 65, are fully vaccinated against the SARS-CoV-2 virus responsible for COVID-19. There’s no question that full vaccination is the best way to protect yourself against this devastating virus and reduce your chances of developing severe or long-lasting illness if you do get sick. But, to stay ahead of this terrible virus, important questions do remain. A big one right now is: How soon will booster shots be needed and for whom?


FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations


23 Sep 2021

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in: individuals 65 years of age and older; individuals 18 through 64 years of age at high risk of severe COVID-19; and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19


The Most Common COVID-19 Booster Shot Questions, Answered


23 Sep 2021

The Food and Drug Administration has authorized Pfizer COVID-19 booster shots for people over the age of 65 and other at-risk Americans. The agency’s decision was the latest twist in the ongoing debate about when coronavirus booster shots would be necessary — and for whom.


Covid Live Updates: Extra Dose of J. & J. Vaccine Raises Protection, Company Says


21 Sep 2021

In a clinical trial, researchers found that two doses of the vaccine delivered 94 percent efficacy against mild to severe Covid-19.




Articles


The US Regulatory System and COVID-19 Vaccines The Importance of a Strong and Capable FDA


15 Feb 2021

For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has been a frustrating journey from one disappointment to the next: late access to testing, insufficient staff and inadequate funding for contact tracing, jumbled communications, and, at the end of 2020, a chaotic launch of vaccination efforts.




COVID-19 Vaccination in Pregnant and Lactating Women


08 Feb 2021

Pregnant women with severe or critical coronavirus disease 2019 (COVID-19) infection are at increased risk for preterm birth and pregnancy loss.




Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination


04 Feb 2021

We recently reported the results of a phase 1 trial of a messenger RNA vaccine, mRNA-1273, to prevent infection with SARS-CoV-2; those interim results covered a period of 57 days after the first vaccination.




How the Novavax Vaccine Works


03 Feb 2021

The Maryland-based company Novavax has developed a protein-based coronavirus vaccine called NVX-CoV2373. The vaccine produced strikingly high levels of antibodies in early clinical trials.




Evaluation of Cloth Masks and Modified Procedure Masks as Personal Protective Equipment for the Public During the COVID-19 Pandemic


19 Jan 2021

Severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2), the cause of coronavirus disease 2019 (COVID- 19), is a transmissible virus that infects the upper and lower respiratory tract, leading to a high viral titer in saliva and respiratory secretions.




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