BioPharma, Pharma

Covid news roundup: Boosters for kids, breath diagnostic, a vax approval & more

Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid news, a vaccine developer won marketing authorization in Europe while another one faces a regulatory setback.


Covid-19 booster shots could be coming soon for children ages 5 to 11. Pfizer and BioNTech released clinical data for their messenger RNA vaccine from a study in children ages 5 through 11, and based on those preliminary results the companies said they plan to seek emergency authorization for a third shot in this age group.

The booster data come less than six months after the FDA authorized the Pfizer/BioNTech vaccine for children 5 to 11. That 10 microgram shot is a smaller dose than the 30 microgram version of the vaccine that is approved for adults.

A Phase 2/3 study is evaluating a booster dose in 140 children. Those study participants received a third shot about six months after the second dose of the initial two-shot regimen. The early results showed a six-fold increase in neutralizing antibodies against the original, unmutated version of SARS-CoV-2, the companies reported on April 14. A subgroup of 30 blood samples from the study were tested against the omicron variant. According to the preliminary results, levels of neutralizing antibodies increased 36-fold against that variant.

When Pfizer and BioNTech reported the latest pediatric data for their Covid vaccine, they said they expected to submit an application for emergency authorization for boosters in children in coming days. They added that they plan to share the data with the European Medicines Agency and other regulatory bodies around the world soon.

More than 10,000 children younger than 12 have participated in clinical trials evaluating Pfizer and BioNTech’s Covid vaccine. The companies reported that in this most recent cut of data, the vaccine continued to be well tolerated with no new safety signals observed. The number of U.S. children who could receive a booster from the Pfizer and BioNTech vaccine remains small. According to the Centers for Disease Control and Prevention, just 3% of children age 5 to 11 are fully vaccinated.

The past week saw other developments in Covid-19 vaccines, drugs, and diagnostics. Here’s a recap of the news.

—More than 400 tests and sample collection devices have FDA emergency use authorization for Covid-19. The agency has authorized the first one that works by analyzing breath. The InspectIR COVID-19 Breathalyzer, developed by a company named InspectIR Systems, isn’t for home use. The instrument is about the size of a piece of carry-on luggage and the test must be administered by a healthcare professional. It uses mass spectrometry to analyze breath samples and produces results within three minutes.

The FDA said the InspectIR diagnostic was evaluated in a study enrolling 2,409 people, including those with and without symptoms. The sensitivity of the diagnostic, meaning the percentage of positive samples that were correctly identified, was 91.2%. The diagnostic’s specificity, which is the percentage of negative samples correctly identified, was 99.3%. The FDA said a follow-up study focused on the omicron variant yielded similar results.

—A Covid-19 vaccine developed by Valneva was granted conditional marketing authorization in the U.K. for adults 18 to 50 years old. The vaccine, VLA2001, is comprised of whole inactivated particles of SARS-CoV-2 combined with two adjuvants that boost the immune response. It’s the only vaccine of this type that has entered clinical trials in Europe.

—Regeneron Pharmaceuticals faces a delay for its application seeking regulatory approval for its Covid-19 antibody drug as a treatment non-hospitalized patients and as for prophylactic applications in certain people. The FDA extended its review of the drug, REGEN-COV, by three months; a decision is now expected by July 13. According to the Tarrytown, New York-based company, additional discussion about prophylactic use required the submission of additional data, which requires additional time to review. No new clinical studies were requested.

The Regeneron drug combines two antibodies, casirivimab and imdevimab. The drug cocktail was granted emergency use authorization in late 2020; its ineffectiveness against newer variants led to agency to revoke that authorization. Meanwhile, the company continues clinical development of next-generation antibodies hoped to be effective against currently circulating variants of concern.

—The FDA placed a clinical hold on a Phase 2/3 test of Ocugen’s Covid-19 vaccine Covaxin. The move follows the company’s voluntary pause in dosing while it evaluates the World Health Organization’s call to suspend supplies of the vaccine after the agency found manufacturing deficiencies at Indian company Bharat Biotech, which developed the vaccine. Malvern, Pennsylvania-based Ocugen has exclusive U.S. rights to Covaxin.

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