Pregnant, Breastfeeding Moms Can Opt For Shot, Though It Was Not Tested
Though Pfizer has not yet tested its vaccine on people who are pregnant or breastfeeding, the FDA allowed them under the emergency use authorization -- deciding that the benefits of COVID immunization likely outweigh the possible risks. Other news on expected side effects are reported.
The New York Times:
Pregnant And Breastfeeding Women May Opt To Receive The Vaccine
In its emergency authorization of the Pfizer-BioNTech vaccine on Friday night, the Food and Drug Administration took an unexpected step, leaving open the possibility that pregnant and breastfeeding women may opt for immunization against the coronavirus. The agency authorized the vaccine for anyone 16 and older, and asked Pfizer to file regular reports on the safety of the vaccine, including its use in pregnant women. (Mandavilli, 12/11)
Philadelphia Inquirer:
The COVID-19 Vaccine Wasn’t Tested In Pregnancy, But Experts Say It’s Still Worth Considering If You’re Expecting
As health-care workers prepare to receive Pfizer’s COVID-19 vaccine starting this week, a Centers for Disease Control and Prevention committee has recommended that pregnant workers — a group typically excluded from vaccine trials — still be allowed to decide with their doctors whether to receive the vaccine. The majority of health-care workers are women, and Johns Hopkins University researchers noted in STAT News last week that an estimated 330,000 in this workforce “will be pregnant or breastfeeding as initial doses of vaccine are being distributed.” Even more could become pregnant in the weeks between administration of the two doses of vaccine required for full protection from the virus. (Whelan, 12/14)
People with a history of allergic reactions should talk to their doctors —
Stat:
CDC Says People With History Of Severe Allergic Reaction Can Get Covid-19 Vaccine
The Centers for Disease Control and Prevention on Sunday said people who have experienced severe reactions to prior vaccines or injectable drugs can still get the Pfizer/BioNTech vaccine for Covid-19, but should discuss the risks with their doctors and be monitored for 30 minutes afterward. The guidance is a shift from a prior proposal laid out Saturday that would have recommended against vaccination for that group of people. (Ross, 12/13)
Stat:
Experts Grapple With Covid-19 Vaccine Guidance On Severe Allergies
An independent advisory committee to the Centers for Disease Control and Prevention voted overwhelmingly on Saturday to recommend use of the Covid-19 vaccine made by Pfizer and BioNTech. But the meeting also revealed an apparent divide in thinking on whether the vaccine should be given to people with a history of severe allergic reactions to other medicines, a determination that could prevent hundreds of thousands of people from receiving it. (Ross, 12/12)
The Washington Post:
Coronavirus Vaccines Can Have Side Effects. That Typically Means They’re Working.
The new coronavirus vaccine appears to be stunningly effective — blocking serious illness entirely in randomized trials — and it has passed strict safety reviews and won emergency authorization from regulators in the United States and several other countries so far. But news bulletins in the past week provided a reminder that this remains a revolutionary pharmaceutical agent that will be scrutinized in the months ahead as shots go into arms. Among the unknowns: To what extent does the vaccine prevent infection vs. simply preventing clinical illness? (Achenbach, 12/13)
And CDC advisers agreed that the vaccine is safe for 16-year-olds —
NPR:
CDC Advisers Agree With FDA: COVID-19 Vaccine Is OK For Public Use
An important federal advisory committee at the Centers for Disease Control and Prevention has added its vote of support for the Pfizer-BioNTech COVID-19 vaccine. In an emergency meeting Saturday, the CDC's Advisory Committee on Immunization Practices voted to recommend the first COVID-19 vaccine for use for people 16 or older in the U.S, expressing hope that the vaccine would help curb the spread of the disease that has killed more than 295,000 people in the U.S. (Huang, Simmons-Duffin and Wroth, 12/12)
The Hill:
CDC Director Accepts Advisory Panel's Recommendation, Clearing The Way For Vaccinations To Begin
The director of the Centers for Disease Control and Prevention (CDC) has signed off on an advisory panel's recommendation to use Pfizer and BioNTech’s COVID-19 vaccine in people 16 and older, clearing the way for inoculations to begin. “As COVID-19 cases continue to surge throughout the U.S., CDC’s recommendation comes at a critical time. Initial COVID-19 vaccination is set to start as early as Monday, and this is the next step in our efforts to protect Americans, reduce the impact of the COVID-19 pandemic, and help restore some normalcy to our lives and our country,” Robert Redfield said in a statement on Sunday. (Budryk, 12/13)
