Vaccines

Adding v-safe active monitoring to VAERS passive reporting produced "most comprehensive" program, and affirmed COVID-19 vaccine safety.

Here is a rundown of the most popular stories we covered this past week.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met today to discuss how to proceed with informing future COVID-19 vaccine strain composition and booster decisions.

After the US Food and Drug Administration (FDA) fully authorized the Pfizer-BioNTech mRNA vaccine, series-completing second doses increased substantially. However, first vaccine doses were actually administered at lower rates after the approval.

New data coming from Israel shows the Pfizer-BioNTech COVID-19 vaccine did offer some protection initially, but waning immunity occurs rapidly.

A new study found people who staunchly oppose COVID-19 vaccines were more likely to have experienced adverse childhoods, making them distrustful from a young age.

A pair of new studies in the Journal of the American Medical Association add to growing evidence that COVID-19 vaccines are safe during pregnancy, showing no increased risk for adverse outcomes among women who were vaccinated during pregnancy and their babies.

Here is a rundown of the most popular stories we covered this past week.

One day after the FDA approved second booster shots for certain vulnerable populations, the National Institute of Health (NIH) announced they have begun enrolling adult US participants in a phase 2 clinical trial to evaluate a second COVID-19 booster dose.

2 doses of the Pfizer-BioNTech vaccine reduced Omicron hospitalizations by 68% in children 5-11 and by 40% in adolescents 12-18 years old.

The Pfizer-BioNTech and Moderna mRNA vaccines were found to produce different antibody and killer T-cell responses, suggesting a “mix and match” booster approach may provide the best protection against COVID-19.

New policy appears inconsistent and, on the surface, unfair, expert says.

The new action by the federal agency now means the additional booster shot can be administered to people 50 years and older.

The federal agency is expected to provide the EUAs prior to their next VRBPAC meeting on April 6.

Check out the important stories we covered this week.

The company is developing a single combination vaccine to cover SARS-CoV-2, influenza, and respiratory syncytial virus (RSV) as well as another candidate for endemic human coronaviruses.

This designation of the company’s respiratory syncytial virus (RSV) vaccine candidate, PF-06928316, will help to expedite its development and review.

The findings are significant given that a second booster dose may soon be recommended.

COVID-19 vaccines were less protective against symptomatic infection from the Omicron COVID-19 variant than the Delta variant.

Recent booster shots of mRNA vaccines prevented severe infection, hospitalization and death during the Omicron wave of the pandemic, despite a higher rate of breakthrough infections than was seen during the Delta wave, a new study found.

Check out these important stories we covered this past week.

The submission is for a fourth dose of its Spikevax (mRNA-1273) vaccine in adults 18 years of age and older.

A study of over 8 million participants found no correlation between COVID-19 vaccination and developing neurological conditions. However, a risk of some neurological conditions was increased after COVID-19 infection.

A recent JAMA article discussed the role of caregiver vaccination status in pediatric hospitals and ethics of exclusion.

Pfizer’s COVID-19 pill Paxlovid, which includes nirmatrelvir and ritonavir, reduced the risk of hospitalization and death by 89% among adults at high risk for severe disease, recently published phase 2/3 trial data show.

The application is based on 2 Israeli studies for the additional shot for people 65 years and older.

In children and adolescents, the Pfizer-BioNTech vaccine was only mildly effective against symptomatic and asymptomatic COVID-19 infections. Broken down by variant, Omicron infections were more likely to occur and more likely to be asymptomatic.

This study comes just weeks after the company announced another HIV vaccine trial.

With 3 vaccine candidates, the National Institutes of Health (NIH) is launching one of the first trials to examine the safety and efficacy of mRNA technology in HIV vaccination.

In a nationally televised interview, Pfizer Albert Bourla said it is necessary to fend off waning protection.