Covid-19 roundup: Pfizer, BioNTech seek authorization of vaccine for 5- to 11-year-olds; Finland halts rollout of Moderna vaccine in younger men — report
Pfizer and BioNTech have officially asked the FDA to authorize their Covid-19 vaccine for emergency use in children between the ages of 5 and 11 years old, the pharma announced Thursday on Twitter.
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Oct. 26 to discuss the submission. If approved, the Covid-19 vaccine would be the first available to kids of this age group.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” acting FDA commissioner Janet Woodcock said in a statement.
UPDATE: We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12. pic.twitter.com/72Z2HXlkOx
— Pfizer Inc. (@pfizer) October 7, 2021
The news comes just over a week after Pfizer and BioNTech submitted initial data from their pediatric trial to the agency, showing a 10 μg dose given to children between 5 and 11 years old achieved a comparable response to 30 μg doses given to people between 16 and 25. The 10 μg dose was “carefully selected as the preferred dose for safety, tolerability and immunogenicity” in the younger age group, the companies said.
Topline readouts on the vaccine’s performance in children between 2 and 4 years old, and between 6 months and 1 year old are expected by the fourth quarter of this year.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer tweeted on Thursday.
According to the pharma, children under the age of 18 accounted for around 27% of all Covid cases in the US last week. Officials told the Washington Post that an authorization for 5- to 11-year-olds could come between Halloween and Thanksgiving.
Finland halts rollout of Moderna vaccine in younger men over heart inflammation — report
Finland is slamming the brakes on the use of Moderna’s Covid-19 vaccine in younger men over reports of a rare cardiovascular side effect called myocarditis, Reuters reported on Thursday.
Myocarditis refers to inflammation of the middle layer of the heart wall, which can lead to chest pain, an abnormal heartbeat, and shortness of breath. Mika Salminen, director of the Finnish health institute, said an unpublished study in Sweden, Finland, Norway and Denmark showed men under the age of 30 who received Moderna’s shot were at a slightly higher risk of developing the condition.
As a result, Saminen said Pfizer’s vaccine would now be given to men born after 1991, according to Reuters.
It was first reported that Sweden and Denmark had also paused distribution of the vaccine in younger men, but Denmark said on Friday that it was still offering Moderna’s vaccine to men under 18, and that any suggestion otherwise had been a miscommunication.
“The Danish Health Agency continues to assess that both COVID-19 vaccines, both the one from Pfizer/BioNTech and the one from Moderna, are highly effective vaccines that have an important place in the general vaccination programme in Denmark,” the Danish Health Agency said, per Reuters.
A Moderna spokesperson told the news agency that the myocarditis cases were typically mild, and individuals tend to recover in a “short time following standard treatment and rest.”
Myocarditis, the spokesperson pointed out, is also a risk after Covid-19 infection.
The CDC has noted that cases of myocarditis have been reported after vaccination with both the Pfizer-BioNTech and Moderna vaccines, especially in male adolescents and young adults. But the agency has stressed that the benefits of the vaccine far outweigh the risks.
“The known risks of COVID-19 illness and its related, possibly severe complications, such as long-term health problems, hospitalization, and even death, far outweigh the potential risks of having a rare adverse reaction to vaccination, including the possible risk of myocarditis or pericarditis,” the CDC said in a statement.
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