There is — still — plenty of news about COVID-19 and new drugs, therapies and FDA applications. Here’s a look.
There is — still — plenty of news about COVID-19 and new drugs, therapies and FDA applications. Here’s a look.
J&J Requested Booster Shot Authorization
Johnson & Johnson submitted data to the FDA to authorize a second booster shot for its one-shot COVID-19 vaccine. In this circumstance, the company indicated it had left who should get the booster up to the FDA and the U.S. Centers for Disease Control and Prevention (CDC).
“We’re describing the data to them,” Mathai Mammen, Head of Global Research and Development for Janssen, a J&J company, told CNN. “The process is not that we asked for a very specific interval — we’re providing them data and we’re going to be presenting to the committee. They’ll take all that into consideration when they ultimately decide on an appropriate interval.”
The FDA’s Vaccine and Related Biological Products Advisory Committee is scheduled for October 14 and 15 to consider Moderna and J&J’s booster dose requests.
Pfizer-BioNTech Vaccine 90% Effective Against Hospitalization/Death Up to 6 Months After 2nd Dose
A new study from Pfizer and the Kaiser Permanente Southern California health system found that the Pfizer-BioNTech COVID-19 vaccine was still 90% effective at protecting against hospitalization and death up to six months after the second dose. They analyzed more than 3.4 million people from Kaiser Permanente between December 2020 and August 2021. The research was published in The Lancet.
The data also demonstrated that the vaccine’s effectiveness waned over time, going from 88% to 47% six months after the second dose, “probably primarily due to waning immunity with time rather than the delta variant escaping vaccine protection.”
Model Suggests Natural COVID-19 Immunity Drops Fast
Researchers with the Yale School of Public Health and the University of North Carolina at Charlotte published a study in The Lancet Microbe that suggests that protection after natural infection is short-lived.
“Reinfection can reasonably happen in three months or less,” said Jeffrey Townsend, the Elihu Professor of Biostatistics at the Yale School of Public Health and lead author of the study. “Therefore, those who have been naturally infected should get vaccinated. Previous infection alone can offer very little long-term protection.”
The researchers analyzed data about reinfection and immunological numbers from the close viral relatives of SARS-CoV-2 that cause “common colds” as well as data from SARS-CoV-1 (SARS) and Middle East Respiratory Syndrome (MERS). Using evolutionary principles, they modeled the risk of COVID-19 reinfection over time. Their model has similarities to reinfection risks over time between COVID-19 and endemic coronaviruses, which is to say, coronaviruses that cause colds or other illnesses.
Ottawa Paper Near and Dear to Anti-Vaxxers Retracted Due to Major Error
Researchers at The University of Ottawa Heart Institute retracted a study posted on a preprint server after noting a major error. They had falsely calculated heart inflammation (myocarditis) as 1 in 1,000 for Moderna’s and Pfizer-BioNTech’s vaccines. Many anti-vaxxers began supporting and distributing the study as proof that the vaccines were dangerous.
In the retraction, the authors wrote, “During the process of open peer review on MedRxiv, we quickly received a number of messages from reviewers concerned that there was a problem with our reported incidence of myocarditis post mRNA vaccination. Our reported incidence appeared vastly inflated by an incorrectly small denominator (i.e., number of doses administered over the time period of the study). We reviewed the data available at Open Ottawa and found that there had indeed been a major underestimation, with the actual number of administered doses being more than 800,000 (much higher than quoted in the paper).”
FDA Authorized LabCorp’s At-Home COVID-19/Flu Test Kit
The FDA approved LabCorp’s at-home test kit for COVID-19 and influenza A and B. With the kit, people can swab their nose and mail in a sample. They will get the results approximately one to two days after LabCorp receives the kit. The test was first developed by Roche and authorized in September 2020. The authorization is only for people who meet criteria as evaluated by a healthcare provider, including COVID-19 symptoms or possible exposure to someone with COVID-19. No price has been announced, although earlier LabCorp at-home test kits for COVID-19 ran $119.
Antibody Tests for COVID-19 Don’t Tell You Much
Some people are getting antibody tests to determine if, either from natural infection or from being vaccinated, they have developed enough antibodies against SARS-CoV-2, the virus that causes COVID-19, to be immune to infection or reinfection. The CDC and FDA have advised against using antibody tests in this manner, and the Infectious Disease Society of America agrees.
At issue is that although the tests may indicate the presence or possibly the level of antibodies against SARS-CoV-2 in the bloodstream, nobody really knows what number provides protection against the disease. It’s not totally worthless. It can tell you if someone with symptoms had an earlier, undetected COVID-19 infection. But most people taking antibody tests are trying to see if they have waning immunity.
Alan Wells, director of clinical labs at the University of Pittsburgh Medical Center, said, “For a normal person, knowing your level eight months later [after their initial vaccine dosages] is of relatively little value.”
