Search results
Sep 13, 2023 · FDA Commissioner Dr. Robert Califf wrote on X, formerly Twitter, on August 25 that clinical trial data from other bivalent mRNA COVID-19 boosters was taken into account for the new boosters.
- 58 sec
Sep 13, 2022 · No, if you want human clinical trial data specifically on the bivalent BA.4/5 booster, you’re gonna have to wait a little while. According to a company announcement on August 31, the human ...
- Overview
- New data finds bivalent boosters may result in more protection, especially for people over 55
- New bivalent boosters found safe
- Long track record of safety
- Scientists monitor vaccine effects
•Pfizer and BioNTech announced in a press release that bivalent booster shots result in far more antibodies to fight SARS-CoV-2, according to study results.
•The FDA has authorized new COVID-19 bivalent boosters for children as young as 5.
•The new COVID-19 boosters were authorized before being tested on humans, but experts say that they are still safe.
•With the COVID-19 vaccines, there is already a long track record of safety to support the new boosters.
Pfizer and BioNTech said in a press release that people who received their bivalent booster shots had far higher levels of antibodies to fight SARS-CoV-2, than people who received previous booster shots.
The companies announced the findings from phase 2/3 studies, but those findings were not yet peer-reviewed.
According to the data published by Pfizer and BioNTech, in people over age 55 the bivalent booster shot was linked to an over 13-fold increase in antibody levels compared to pre-booster levels.
The traditional monovalent booster shots led to a 2.9 fold increase in antibody levels in people over age 55 compared to pre-booster levels.
The bivalent shot was found to lead to a 9.5 fold increase in antibody levels for adults aged 18 to 55, compared to pre-booster levels.
“These data demonstrate that our BA.4/BA.5-adapted bivalent vaccine works as conceptually planned in providing stronger protection against the Omicron BA.4 and BA.5 sublineages,” Dr. Ugur Sahin, CEO and Co-founder of BioNTech said in the statement. “In the next step and as part of our science-based approach we will continue to evaluate the cross-neutralization of the adapted vaccine against new variants and sublineages. Our goal is to provide broader immunity against COVID-19 caused by SARS-CoV-2, including Omicron and other circulating strains.”
The new data from Pfizer and BioNTech comes one day after a study from the U.S. Centers for Disease Control and Prevention found that the new bivalent boosters had a similar safety profile as previous COVID-19 vaccines.
In an effort to get ahead of the rapidly-changing coronavirus, the U.S. Food and Drug Administration authorized these bivalent boosters before data from clinical trials in people was available.
Since the FDA’s initial authorization of the bivalent vaccines, several new coronavirus subvariants have emerged around the world. Dr. Ashish Jha, head of the White House COVID task force, said Oct. 11 during a press briefing that the administration is “carefully monitoring” these strains, including “ones that evade some of our treatments.”
However, because these subvariants all arose from existing Omicron strains, the “updated bivalent vaccines should provide a much higher degree of protection than the original prototype vaccine would have,” said Jha.
The FDA said in a statement in August that it based its decision for the bivalent vaccines on the “totality of available evidence.”
This includes animal studies on the BA.4/5 boosters, clinical trials of bivalent BA.1 boosters, clinical trials of the original vaccines and boosters, and ongoing monitoring of the safety of the current vaccines.
Dr. Mohammad Sobhanie, an infectious disease physician at The Ohio State University Wexner Medical Center in Columbus, Ohio, pointed out that Moderna and Pfizer-BioNTech used the exact same technology to develop the BA.4/5 bivalent boosters as they did their original COVID-19 vaccines, as well as the BA.1 bivalent boosters.
He compared this change to how the seasonal flu vaccines are updated each year to match the influenza strains that are expected to be in circulation. Unless vaccine makers use new technology to produce the flu vaccines, no additional clinical trials are needed.
With the COVID-19 vaccines, there is already a long track record of safety that can be used to support the safety of the BA.4/5 bivalent vaccines.
In the United States alone, over 640 million doses of the mRNA COVID-19 vaccines have been given, including over 26.3 million doses of the bivalent vaccines, according to the CDC
In addition, “there’s nothing dramatically new that’s in the [BA.4/5 bivalent] vaccine, other than that they’ve changed what it’s targeting,” said Sobhanie. “So the safety profile should be similar to that of the original vaccines.”
This vaccine target is the spike protein of the coronavirus, which the virus uses to infect cells. The spike protein of the Omicron and other variants differ from that of the original form of the virus, on which the first vaccines were based.
Even with the FDA authorizing updated vaccines, data show that the original vaccines continue to provide strong protection against severe illness, especially when people have received both the primary series and at least one booster.
“The current vaccines are still holding up,” said Sobhanie. However, “if these updated boosters can prevent more [COVID-19] hospital admissions and deaths, that’s definitely a plus.”
With the bivalent BA.4/5 booster, the United States has a chance to roll out a vaccine that matches the currently circulating version of the virus.
“Hopefully, if you can get vaccinated against these [BA.4 and BA.5], then it should provide protection against infection,” said Sobhanie. “This is something that is pretty useful as we head into the fall and winter months, when people are more likely to gather indoors.”
The inclusion of the original formulation of the vaccine in the booster provides a hedge against a variant similar to the original strain arising.
However, scientists don’t know for certain how much protection the updated boosters will offer.
- Shawn Radcliffe
Sep 7, 2022 · Fast Facts. Boosters that target the omicron variant were approved without specific human data on the new vaccine formulation. The Food and Drug Administration fast-tracked the process, but...
- Rebecca Sohn
Feb 7, 2023 · Bivalent booster vaccines against SARS-CoV-2 were 37% more effective than older booster shots at reducing the risk of severe COVID-19. The increased protection against hospitalization or death was seen regardless of age or whether people had previously received a different booster.
Feb 13, 2023 · The bivalent boosters are designed to address both the original strain of the virus and the more contagious omicron variants that have emerged since. In fact, even as newer variants—like BQ.1, BQ.1.1, and XBB.1.5 —become dominant in the U.S., the bivalent boosters are continuing to protect against severe disease, hospitalization, and death.
Oct 14, 2022 · The omicron-adapted COVID-19 booster made by Pfizer and BioNTech is safe and effective in older and younger adults, based on new clinical trial data reported by the drugmakers. The study...
