Covid-19 roundup: FDA authorizes Pfizer/BioNTech vaccine for 12- to 15-year-olds; Novavax shares sink as company delays vaccine timeline
Back-to-school season could look much different this year, as Pfizer and BioNTech’s Covid-19 vaccine has become the first in the US to be authorized for children as young as 12 years old.
On Monday, the FDA expanded its emergency use authorization for the jab — which was originally OK’d for those 16 years and older — based on efficacy data from 190 adolescents which showed their immune response to the vaccine was at least as good as the response seen in older participants.
Pfizer and BioNTech also conducted an analysis seven days after the adolescents were given their second doses. No Covid-19 cases were found among 1,005 12- to 15-year-olds who received the vaccine, versus 16 cases in the placebo group, suggesting the vaccine was 100% effective.
Side effects experienced by a group of 2,260 adolescents who were tested for safety — pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain — were consistent with older groups, according to the agency. More than half of the participants were followed for at least two months after their second dose, according to the companies.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), told reporters in a media briefing that the doses won’t be administered to 12- to 15-year-olds until Thursday (after the CDC holds an Advisory Committee on Immunization Practices meeting).
“We recognize that the next critical step is having vaccines available for use throughout the pediatric population,” Marks said in a statement on Monday.
Both the Moderna and Johnson & Johnson vaccines are currently authorized for adults 18 years and older, though Moderna said last month that its Phase II/III TeenCOVE study was fully enrolled with about 3,000 participants between the ages of 12 and 17 in the US.
CBER is planning to convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10 to provide a status update on the authorization of Covid-19 vaccines for kids 12 and up, and the data needed to support a BLA or EUA in those younger than 12.
“As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range,” Marks said.
Pfizer will continue to monitor the safety of the vaccine.
Novavax shares sink as company delays vaccine timeline
In its Q1 earnings call, Novavax said it’s now aiming to submit regulatory filings in the US, UK and EU in Q3, versus its previous plans to file in Q2. The company cited the development of qualifying and potency assays to satisfy the CMC portion of regulatory submissions as the primary reason for delay, according to Jefferies analyst Kelechi Chikere.
The company now expects to hit its production target of 100 million doses a month by the end of Q3 and full production capacity in Q4 (rather than Q3). Here, Novavax said sourcing raw materials was its key issue.
“Mgmt remains very confident that they will hit 150M doses per month before the end of the year and expects to maintain that throughout 2022 and beyond,” Chikere wrote.
This isn’t the first time Novavax has pushed back its timeline for full-speed vaccine production. Last month, Reuters reported that supply shortages that include bags used to grow cells have led to a delay in production. Previously, Novavax had said that it expected full-scale production by May or June, and clearance from the US as early as May.
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