Covid-19 roundup: CDC advisors find likely link between mRNA vaccines and rare cases of heart inflammation; NIH launches new vaccine study in pregnant volunteers
The FDA will update the fact sheets for the Pfizer/BioNTech and Moderna Covid-19 vaccines, after the CDC advisory group ACIP found that rare cases of heart inflammation in adolescents and young adults are likely linked to the shots, Reuters reported.
According to the CDC’s website, there have been more than a thousand reports of heart inflammation following mRNA vaccination since April. These cases are rare, according to the agency, given the hundreds of millions of doses administered. Most have been mild, and individuals often recover on their own or with minimal treatment, several public health figures said in a joint statement.
“In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe,” they said in the statement. “We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated, as the benefits of vaccination far outweigh any harm.”
Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, said that data from one safety monitoring system suggests 12.6 cases of heart inflammation per million 12- to 39-year-olds in the three weeks following the second shot, per Reuters.
“We’re observing this in the younger age groups, mainly in people in the teens and early 20s, and observing it more in males, compared to females,” he said, according to Reuters. “This effect largely kind of disappears once you get into these older age groups – individuals 50 and over.”
The CDC has advised those getting the shots to be on the lookout for chest pain, shortness of breath, and a fast-beating, fluttering or pounding heart.
NIH launches new vaccine study in pregnant volunteers
Although tens of thousands of pregnant or breastfeeding people in the US have already received a Covid-19 shot, the NIH is launching a new study to evaluate the shots in this group, according to NIAID director Anthony Fauci.
The study, dubbed MOMI-VAX, will enroll up to 750 pregnant participants and 250 who have given birth in the last two months who have received or will receive any Covid-19 vaccine authorized in the US. Currently, that includes the Pfizer/BioNTech, Moderna and J&J jabs.
Researchers will then measure vaccine safety, the development and durability of antibodies against SARS-CoV-2, and the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.
“The results of this study will fill gaps in our knowledge and help inform policy recommendations and personal decision-making on COVID-19 vaccination during pregnancy and in the postpartum period,” Fauci said in a statement.
The participants and their babies will be monitored for one year. So far, the vaccines appear safe in pregnant and postpartum populations, the NIH said.
Pregnant people with Covid-19 are more likely to be hospitalized and admitted to the ICU, according to the NIH. They are also more likely to require ventilation, and die from the illness. And severe Covid-19 during pregnancy may put the infant at risk for complications like preterm birth, the agency said.
Pfizer and BioNTech are conducting their own Phase II/III study in pregnant people, and dosed the first of 4,000 participants in February. That trial will vaccinate volunteers during 24 to 34 weeks of gestation, with two doses of the vaccine or placebo given 21 days apart.