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FDA Statement on Vaccines


26 Feb 2021

Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.


Caring for the Caregivers — Covid-19 Vaccination for Essential Members of the Health Care Team


12 Feb 2021

As U.S. states have developed guidelines for Covid-19 vaccination, some have moved to include “paid or unpaid caregivers (including parents or foster parents) of medically fragile children or adults who live at home” in Phase 1 vaccine allocation.


Necessity of 2 Doses of the Pfizer and Moderna COVID-19 Vaccines


03 Feb 2021

Two doses of the Pfizer and Moderna COVID-19 vaccines are necessary to confer adequate immunity. The new vaccines for coronavirus disease 2019 (COVID-19) are highly effective, but controversy exists about whether a second dose should be delayed in order to immunize more people. The second dose is necessary and should be given.


Did you have COVID-19? You could be reinfected by new variants


03 Feb 2021

People who already were infected with COVID-19 could face reinfection if the new coronavirus variants become the dominant strains, Dr. Anthony Fauci said Monday.


Coronavirus is in the air — there’s too much focus on surfaces


02 Feb 2021

Catching the coronavirus from surfaces is rare. The World Health Organization and national public-health agencies need to clarify their advice.




Articles


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.




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.




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