The first Covid-19 vaccine authorized by the FDA for emergency use has become First to receive full regulatory approvalThe marketing name of the vaccine is “Comirnaty”, but although the vaccine originated in BioNTech’s laboratory, everyone still calls it “Pfizer Vaccine”.
The full regulatory approval of the vaccine was the biggest Covid-19 news in the past week, and it was a landmark decision. The approval also revealed the FDA’s concern about the higher risk of inflammation in and around the heart. According to reports, this risk of heart disease is higher in the first week after the second injection and is resolved in most people, but in some cases intensive care is required. The FDA requires Pfizer and BioNTech to conduct post-marketing studies to better understand this risk.
Comirnaty’s approval was the biggest news in a busy week of Covid-19 vaccines, drugs and diagnostic tools. Below is a review of some other major developments.
Pfizer and BioNTech formally apply for approval of booster vaccine
After obtaining the FDA’s full approval of its Covid-19 vaccine, Pfizer and BioNTech started a Rolling application Seek approval of the booster dose with the FDA.Two weeks ago, one The third dose of vaccine received emergency authorization, but only for people with weakened immune systemsThe two companies are supporting their supplementary biologics license application to seek data from the Phase 3 study, which enrolled 306 participants between the ages of 18 and 55. These volunteers received booster injections between 4.8 and 8 months after completing the initial two-dose regimen.
According to Pfizer and BioNTech, the results (not yet published) indicate that the third dose triggered powerful neutralizing antibodies, the level of which was more than three times that after the second dose. The adverse reactions were mild to moderate, consistent with the previous two injections. Pfizer and BioNTech stated that they plan to submit the data to peer-reviewed journals. The two companies also plan to submit data to the European Medicines Agency and other regulatory agencies around the world in the coming weeks.
Moderna completes application for approval of its Covid-19 vaccine
Nearly three months after it began rolling submissions to seek formal approval by the FDA for its emergency-authorized Covid-19 vaccine, Moderna has Complete applicationThe company is seeking approval for the vaccine to be used in adults 18 years of age and older. Moderna’s submission is based on data from a Phase 3 study that recruited more than 30,000 people. In the final data analysis, the vaccine showed 93% efficacy. To date, the company said it has released more than 300 million doses of mRNA vaccines to the federal government.
Johnson & Johnson boasted about boosters, but provided very little support data
Johnson & Johnson is trying to become part of the federal government’s plan to provide Covid booster shots for those who have completed their first vaccination. The pharmaceutical giant reports that some Preliminary clinical data that seems to support the use of additional injectionsThe data has not yet been published and peer reviewed, and little information is provided. Two clinical trials involving more than 2,300 people are ongoing, evaluating vaccines administered in different doses, but the only clinical data J&J pointed out is a sub-study starting with 25 people.
Becton Dickinson obtains EUA for home Covid-19 test
FDA granted Emergency use authorization To the Covid-19 test developed by Becton Dickinson, the test enables people to test at home and get results without having to send anything to the laboratory. The BD Veritor test is a rapid antigen test performed through a smartphone app. Transfer the nasal swab to the test stick. The camera on the user’s mobile device then captures the results, and Scanwell Health’s FDA-approved mobile application uses computer vision technology to analyze and interpret the data. According to BD, the test results can be obtained in about 15 minutes during the entire process.
Brii Bio’s antibody drug portfolio releases positive Phase 3 results
Brii Biosciences publishes encouraging preliminary data Antibody drug combination Test in non-hospitalized patients. The Durham, North Carolina-based biotechnology company stated that its BRII-196 and BRII-198 cocktails had a statistically significant reduction of 78% in the relative risk of the composite endpoint of hospitalization and death compared with placebo. .
The study, sponsored by the National Institute of Allergy and Infectious Diseases, recruited 837 people with Covid infection at high risk of clinical progression. Preliminary results showed that both hospitalizations (12 in the treatment group and 45 in the placebo group) and deaths (1 in the treatment group and 9 in the placebo group) decreased. Brii said that further analysis of patient subgroups may further reveal whether it is helpful to give treatment 5 days or less after the first symptoms appear, and 6 to 10 days after the symptoms appear, this may be a reality. Information about decisions about drug use in the world.
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