The first Covid-19 vaccine to secure FDA emergency use authorization has become the first one to land full regulatory approval. That vaccine has a marketing name, “Comirnaty,” but everyone still calls it “the Pfizer vaccine” despite that vaccine’s origins in the labs of BioNTech.
Full regulatory approval of the vaccine was the biggest Covid-19 news of the past week, a landmark decision to be sure. The approval also revealed FDA’s concern about a higher risk of inflammation in and around the heart. This heart risk, reportedly higher in the first week following the second shot, resolved in most people but required intensive care in some cases. The FDA is requiring Pfizer and BioNTech to conduct post-marketing studies to better understand that risk.
Comirnaty’s approval was the biggest news in a busy week for Covid-19 vaccines, drugs, and diagnostics. Here’s a look back at some of the other major developments.
Pfizer, BioNTech formally file for approval of booster vaccine
On the heels of landing full FDA approval for their Covid-19 vaccine, Pfizer and BioNTech began a rolling application with the FDA seeking approval of a booster dose. Two weeks ago, a third dose of the vaccine received emergency authorization but only for people with weakened immune systems. The companies are supporting their supplemental biologics license application seeking for the boosters with data from a Phase 3 study enrolling 306 participants ranging from 18 to 55 years of age. Those volunteers received booster shots between 4.8 months and 8 months after completing the initial two-dose regimen.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
According to Pfizer and BioNTech, the results (which have not yet been published) showed that a third dose elicited robust neutralizing antibodies to levels more than three times higher than after the second dose. Adverse reactions were mild to moderate, consistent with the first two shots. Pfizer and BioNTech said that they plan to submit the data to a peer-reviewed journal. The companies also plan to file the data with the European Medicines Agency and other regulatory bodies around the world in coming weeks.
Moderna completes application for approval of its Covid-19 vaccine
Nearly three months after beginning a rolling submission seeking formal FDA approval for its emergency authorized Covid-19 vaccine, Moderna has completed its application. The company is seeking approval of the vaccine in adults 18 and older. Moderna’s submission is based on data from a Phase 3 study that enrolled more than 30,000 people. In the final data analysis, the vaccine showed 93% efficacy. To date, the company said that it has released more than 300 million doses of the mRNA vaccine to the federal government.
J&J boasts about boosters but offers little supporting data
Johnson & Johnson is angling to be part of the federal government’s plan to offer Covid booster shots for those who have completed the first course of vaccination and the pharmaceutical giant reported some preliminary clinical data that appear to support the use of an additional injection of its shot. The data have not yet been published and peer reviewed, and the information provided was scant. Two clinical trials enrolling more than 2,300 are underway evaluating vaccines given at various dosing schedules but the only clinical data that J&J would point to is a sub-study that started out with 25 people.
Becton Dickinson gets EUA for at-home Covid-19 test
The FDA granted emergency use authorization to an Covid-19 test developed by Becton Dickinson that enables people to conduct tests at home and get results without sending anything to a lab. The test, BD Veritor, is a rapid antigen test conducted via a smartphone app. A nasal swab is transferred to a test stick. The camera on the user’s mobile device then captures the results, and an FDA-cleared mobile app from Scanwell Health analyzes and interprets the data using computer vision technology. BD said that the entire process yields test results in about 15 minutes.
Brii Bio’s antibody drug combo posts positive Phase 3 results
Brii Biosciences posted encouraging preliminary data for an antibody drug combination tested in non-hospitalized patients. The Durham, North Carolina-based biotech said that its BRII-196 and BRII-198 cocktail showed a statistically significant 78% reduction in relative risk in the combined endpoint of hospitalization and death compared to a placebo.
The study, which was sponsored by the National Institute of Allergy and Infectious Diseases, enrolled 837 people whose Covid infection was at a high risk of clinical progression. The preliminary results showed a reduction in both hospitalizations (12 in the treatment group compared to 45 in the placebo arm) and deaths (one in the treatment group, nine in the placebo group). Brii said that additional analysis of the subgroups of patients may further show if treatment helps when given in five or fewer days following the first sign of symptoms compared to six to 10 days afterward, which could inform real-world decisions about the use of the drug.
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