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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


Assessment of protection against reinfection with SARS-CoV-2 among 4 million PCR-tested individuals in Denmark in 2020: a population-level observational study


17 Mar 2021

The vast majority of people who recover from Covid-19 remain protective immunity from the virus for at least six months, researchers reported on Wednesday in a large study from Denmark. The study revealed protective immunity to be approximately 80–83% in people younger than 65 years. We found no difference in immunity over the study period. Among those aged 65 years and older, immunity was estimated to be approximately 47%.




SARS-CoV-2 Vaccines


26 Feb 2021

Shortly after SARS-CoV emerged at the turn of the 21st century, the spike (S) protein (particularly in its prefusion [native] conformation) was identified as the immunodominant antigen of the virus. Evaluation of patients with SARS-CoV-2 revealed that binding and neutralizing antibodies primarily target the receptor-binding domain of the S1 subunit.




SARS-CoV-2 Variants of Concern in the United States—Challenges and Opportunities


17 Feb 2021

. SARS-CoV-2, like other RNA viruses, constantly changes through mutation, with new variants occurring over time. Generally, when new variants become more common, they do so because of some selective advantage to the virus.




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.




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