After the introduction of COVID-19 vaccines, anecdotal evidence linked the administration of the vaccines with herpes zoster (shingles) infection. A new study published in JAMA Network Open, however, debunks that assertion. Reviewing data from more than two million U.S. recipients of COVID-19 vaccine, the study authors concluded that the incidence rate ratio of shingles following COVID-19…
Pfizer and BioNTech get positive CHMP opinion for updated bivalent BA.4/BA.5-adapted COVID-19 vaccine booster
Pfizer (NYSE: PFE) and its partner BioNTech (Nasdaq:BNTX) could potentially win authorization to market a 30-µg booster dose of their omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine after the Committee for Medicinal Products for Human Use (CHMP) backed the vaccine for individuals 12 and older. The European Commission will likely make a final decision on the updated…
HHS and DOD order 3 million doses of Novavax COVID-19 vaccine
Novavax (Nasdaq:NVAX) announced that its protein-based NVX-CoV2373 COVID-19 vaccine could be the first of its type to be available in the U.S., assuming it wins backing from the FDA and CDC. The U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) have secured 3.2 million doses of Novavax’s COVID-19 vaccine.…
Emergent hid quality problems from FDA, House report concludes
A new congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated. Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in…
FDA curtails use of Janssen COVID-19 vaccine over blood clotting concerns
The FDA has decided to limit the use of the COVID-19 vaccine to individuals at least 18 years old who cannot receive other authorized or approved COVID-19 vaccines. The agency also will authorize its use for individuals who would “otherwise not receive a COVID-19 vaccine.” FDA came to the conclusion after reviewing data related to…
Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11. The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between…
Developing nations shun AstraZeneca’s COVID-19 vaccine
A number of developing nations have refused tens of millions of doses of AstraZeneca’s COVID-19 vaccines, according to a report from Reuters. The countries had received doses of the AstraZeneca vaccine from the COVAX initiative, a global project that focuses on ensuring equitable access to COVID-19 vaccines. COVAX has distributed 1.4 billion shots to 144 nations…
Johnson & Johnson pauses COVID-19 vaccine production in Dutch plant
Johnson & Johnson (NYSE:JNJ) has decided to temporarily suspend production of its COVID-19 vaccine in Leiden in the Netherlands to prioritize production of an investigational respiratory syncytial virus (RSV) vaccine, according to The New York Times. The plant will resume production of its COVID-19 vaccine in a matter of months, the paper reported. The company is…
Israeli advisory committee backs fourth dose of COVID-19 vaccine
Israel could be one of the first countries to begin administering a fourth dose of COVID-19 vaccine to individuals over 18 after a positive advisory committee decision. Before the decision becomes binding, the director of Israel’s Ministry of Health, Nitzan Horowitz, must sign off on the recommendation. If implemented, Israeli adults would be eligible for…
CDC panel recommends COVID-19 boosters for teens
CDC’s Advisory Committee on Immunization Practices (ACIP) voted almost unanimously to support the Pfizer-BioNTech COVID-19 vaccine booster for individuals aged 12 to 17. As with adults, the recommendation applies to individuals who received the second dose at least five months in the past. ACIP also recommended that the CDC bolster its suggestion that adolescents between the…