CDC Advisory Panel To Discuss Vaccine Safety, Guillain-Barré Syndrome

Bloomberg: CDC Vaccine Panel To Discuss J&J’s Covid Vaccine, Guillain-Barré Syndrome
Covid-19 vaccine safety, including the possible risks from a rare immune-system disorder, will be the focus of an advisory panel meeting scheduled by the U.S. Centers for Disease Control and Prevention on July 22. The announcement by the CDC comes a day after the fact sheet for Johnson & Johnson’s Covid-19 shot was revised by federal regulators to warn about a “small possible risk” for Guillain-Barré Syndrome, in which the immune system attacks the nerves. The Advisory Committee on Immunization Practices, or ACIP, includes medical and public health experts that advise the agency on vaccine use and safety. (Rutherford, 7/13)

Fox News: CDC 'Keenly Interested' Whether COVID-19 Booster Vaccines Linked To Higher Risk Of Side Effects, Expert Says
People seeking a COVID-19 booster vaccine dose in hopes of greater protection are doing so as the evidence relating to safety remains unclear, top experts said. A journalist questioned Dr. Jay Butler, deputy director for infectious diseases at the Centers for Disease Control and Prevention (CDC) and Dr. Andrew Pavia, pediatric infectious diseases specialist at University of Utah School of Medicine, over potential safety concerns behind a third dose, noting some fully vaccinated people have sought out booster shots on their own. (Rivas, 7/13)

Axios: The Debate Begins Over The Timeline For COVID Vaccine Boosters 
Conflicting statements from Pfizer and the Biden administration were just the beginning of what will likely be a contentious debate over if and when vaccinated Americans need another shot to protect them against the coronavirus. Making decisions based on emerging science is difficult on a good day. But until global supply outpaces global demand for the vaccine, how to allocate doses will remain a life-or-death decision. (Owens, 7/13)

Stat: Vaccine Developer Sees Booster Shots As Key To Exiting Covid-19 Pandemic
The world will not get the Covid-19 pandemic under control without using booster shots for messenger RNA vaccines, one of the key figures involved in the development of the Pfizer and BioNTech vaccine said Tuesday. Ugur Sahin, co-founder and CEO of BioNTech, insisted booster shots are going to be necessary, despite caution from some experts. “At the end of the day it really matters that we get this pandemic under control. And we will not get it under control without boosting. That’s my strong opinion,” Sahin said. (Branswell, 7/13)

In other vaccine-development news —

CIDRAP: Pfizer COVID Vaccine Shows 78% Efficacy In Pregnancy
Two doses of the Pfizer/BioNTech COVID-19 vaccine were safe and 78% effective in preventing infection in pregnant women in a real-world study in Israel. Led by researchers at Maccabi Healthcare Services in Tel Aviv, the retrospective, observational study was published yesterday in JAMA. It involved analyzing data on 15,060 women in a pregnancy registry of a large, state-mandated healthcare system who were vaccinated with a first dose from Dec 19, 2020, to Feb 28, 2021. (Van Beusekom, 7/13)

CNBC: Fauci Says He Would Be 'Astounded' If Pfizer, Moderna And J&J Covid Vaccines Don't Get Full FDA Approval
White House chief medical advisor Dr. Anthony Fauci fully expects the coronavirus vaccines from Pfizer, Moderna and Johnson & Johnson will receive full approval from U.S. drug regulators, he told CNBC on Tuesday. “The data are about as good as it gets. ... I would be astounded if these vaccines, namely the mRNA and the J&J, didn’t get full approval,” Fauci said on “Squawk Box.” All three Covid vaccines are currently authorized for distribution in the U.S. on an emergency basis, but none of them have received full approval from the Food and Drug Administration yet. Full approval would allow the drugmakers to market the shots directly to consumers and give employers more flexibility in mandating them. (Stankiewicz, 7/13)