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COVID-19 Boosters This Fall to Include Omicron Antigen, but Questions Remain About Its Value


11 Jul 2022

Probably many people who watched or participated in the June 28 virtual US Food and Drug Administration (FDA) advisory committee meeting about updating COVID-19 vaccines could agree on 1 point, made by the agency’s Peter Marks, MD, Ph.D: “It is science at its hardest.” More New Online Views 8,944 Citations 0 25 Medical News & Perspectives July 8, 2022 COVID-19 Boosters This Fall to Include Omicron Antigen, but Questions Remain About Its Value Rita Rubin, MA Article Information JAMA. Published online July 8, 2022. doi:10.1001/jama.2022.11252 related articles icon Related Articles Probably many people who watched or participated in the June 28 virtual US Food and Drug Administration (FDA) advisory committee meeting about updating COVID-19 vaccines could agree on 1 point, made by the agency’s Peter Marks, MD, PhD: “It is science at its hardest.” The SARS-CoV-2 Omicron variant is shown as green dots budding from a vero mammalian kidney epithelial cell 36 hours after infection. The SARS-CoV-2 Omicron variant is shown as green dots budding from a vero mammalian kidney epithelial cell 36 hours after infection. Steve Gschmeissner/sciencesource.com The FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss whether to add an Omicron component to boosters for the fall. In order to have enough doses by early October, “we will need to very rapidly move to let companies know what that selection will be,” Marks reminded the panelists. (How many doses will be enough isn’t clear—as of June 30, only 51.1% of fully vaccinated US adults aged 18 years or older had received 1 booster shot, while only 27% of fully vaccinated adults aged 50 years or older, for whom a second booster is recommended, had received 2, according to government data.)


COVID-19 Vaccines for Kids Under 5: What Parents Need To Know


19 Jun 2022

After multiple delays, very young children are finally eligible for COVID-19 vaccination. In mid-June, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Pfizer’s COVID-19 vaccine for children ages 6 months to 5 years, as well as to Moderna's vaccine for kids ages 6 months to 6 years. The Centers for Disease Control and Prevention (CDC) soon after recommended the vaccines, which should become available early next week.


Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age


17 Jun 2022

Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older. For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older.


Using AI to Advance Understanding of Long COVID Syndrome


07 Jun 2022

The COVID-19 pandemic continues to present considerable public health challenges in the United States and around the globe. One of the most puzzling is why many people who get over an initial and often relatively mild COVID illness later develop new and potentially debilitating symptoms. These symptoms run the gamut including fatigue, shortness of breath, brain fog, anxiety, and gastrointestinal trouble.


The E.U. will no longer recommend that masks be required for air travel.


11 May 2022

The European Union will no longer recommend that member states require face masks on planes and in airports, two E.U. agencies announced on Wednesday, ending a guideline that had been in place for nearly two years as countries across the bloc lift Covid restrictions.




Articles


Coverage and Estimated Effectiveness of mRNA COVID-19 Vaccines Among US Veterans


06 Oct 2021

Question What was the COVID-19 vaccination coverage and estimated mRNA COVID-19 vaccine effectiveness (VE) among US veterans in the first 3 months following vaccine rollout? Findings In this case-control study including 6 647 733 veterans, 23% of veterans received at least 1 COVID-19 vaccination during the first 3 months of vaccine rollout. VE against infection was estimated to be 95% for full vaccination; estimated VE against COVID-19-related hospitalization was 91%, and there were no COVID-19–related deaths among fully vaccinated veterans. Meaning These findings suggest that early vaccination rollout for veterans was efficient, and estimated VE was high for this diverse US population.




Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel


15 Sep 2021

Background: On July 30, 2021, the administration of a third (booster) dose of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) was approved in Israel for persons who were 60 years of age or older and who had received a second dose of vaccine at least 5 months earlier. Data are needed regarding the effect of the booster dose on the rate of confirmed coronavirus 2019 disease (Covid-19) and the rate of severe illness. Conclusions: In this study involving participants who were 60 years of age or older and had received two doses of the BNT162b2 vaccine at least 5 months earlier, we found that the rates of confirmed Covid-19 and severe illness were substantially lower among those who received a booster (third) dose of the BNT162b2 vaccine.




Surveillance for Adverse Events After COVID-19 mRNA Vaccination


03 Sep 2021

Question Are mRNA COVID-19 vaccines associated with increased risk for serious health outcomes during days 1 to 21 after vaccination? Findings In this interim analysis of surveillance data from 6.2 million persons who received 11.8 million doses of an mRNA vaccine, event rates for 23 serious health outcomes were not significantly higher for individuals 1 to 21 days after vaccination compared with similar individuals at 22 to 42 days after vaccination.




Variants of SARS-CoV-2


13 Aug 2021

When a virus develops a new mutation, it is called a variant of the original virus. As viruses spread, they constantly change through mutations to their genetic code. Most mutations in the SARS-CoV-2 genome do not affect the functioning of the virus. However, mutations in the spike protein of SARS-CoV-2, which binds to receptors on cells lining the inside of the human nose, may make the virus easier to spread or affect how well vaccines protect people. Other mutations may lead to SARS-CoV-2 being less responsive to treatments for COVID-19.




Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients


11 Aug 2021

In organ-transplant recipients, the standard two-dose vaccination strategy for coronavirus disease 2019 (Covid-19) has suboptimal immunogenicity.1 Both patients and health care providers have questioned whether a third-dose booster in transplant recipients would be safe and enhance immune response.2 We performed a double-blind, randomized, controlled trial of a third dose of mRNA-1273 vaccine (Moderna) as compared with placebo (the protocol is available with the full text of this letter at NEJM.org; ClinicalTrials.gov number, NCT04885907. opens in new tab).




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