Main Topic: Pfizer's updated Covid boosters could be authorized by the FDA by the end of August.
Key Points:
1. Pfizer CEO Albert Bourla stated that the FDA could authorize the updated Covid boosters by the end of August.
2. Pfizer and Moderna requested the FDA to update their shots to target the XBB.1.5 subvariant, as advised by the FDA.
3. Covid hospitalizations are rising in the US, and Bourla expects a new Covid wave to start in the fall.
Main Topic: Global disease experts are monitoring a new variant, BA.2.86, that carries a large number of mutations and may be capable of sidestepping vaccine protection to some degree.
Key Points:
1. BA.2.86 is significantly different from the original Omicron variant and the previously dominant strain targeted by upcoming Covid booster shots.
2. Only a handful of cases of the BA.2.86 variant have been identified globally, but it is being closely monitored by the World Health Organization and the Centers for Disease Control and Prevention.
3. It is uncertain how transmissible BA.2.86 is, but experts believe it is capable of evading antibodies from prior infections and vaccinations. The impact of BA.2.86 on booster shots and case counts is still unknown.
The Centers for Disease Control and Prevention (CDC) expects updated COVID-19 vaccines from Pfizer, Moderna, and Novavax to be available to the public in mid-September, providing a more specific timeline for the arrival of the shots, pending approvals from the FDA and CDC.
The United States is still weeks away from distributing Covid booster shots, despite a 21.6% increase in hospitalizations related to the virus, and the effectiveness of the boosters against new virus variants remains uncertain.
An updated version of the COVID-19 vaccine designed to target the Omicron subvariant XBB.1.5, known as Kraken, is expected to be released earlier than anticipated, potentially by mid-September, as coronavirus cases and hospitalizations rise across California and the US.
The U.S. is experiencing a rise in Covid cases just as new vaccines that protect against the latest variants are almost ready.
Moderna's updated COVID-19 vaccine is likely to be effective against the highly-mutated BA.2.86 subvariant of the coronavirus, according to clinical trial data, providing reassurance for fall boosters and regulators.
Antibodies from prior infection or existing vaccines are effective against the BA.2.86 variant, and the increase in COVID cases in the US is not driven by this variant, according to the CDC.
Two new Covid shots from Pfizer-BioNTech and Moderna have been approved by the FDA and are expected to be available soon as cases continue to rise in some parts of the US, with preliminary research suggesting they offer protection against the dominant variant and other concerning variants.
The FDA has approved updated COVID-19 vaccine and booster shots, targeting new variants, and making them available for Americans as young as 6 months old from Moderna and Pfizer.
Americans can now receive an updated COVID-19 vaccine to reduce the severity of symptoms, protect against current variants, and curb the risk of "long COVID."
Moderna's flu vaccine has demonstrated a stronger immune response against all strains of the influenza virus compared to traditional flu shots, potentially allowing the company to file for accelerated approval in the US by year-end and launch the vaccine for the 2024/2025 season, while also scaling down its COVID-19 vaccine manufacturing to meet lower post-pandemic demand.
Moderna's combination vaccine targeting Covid and the flu, mRNA-1083, has shown positive results in an early to mid-stage study and will move to a final stage trial in adults aged 50 and above with hopes of gaining regulatory approval in 2025, potentially simplifying protection against respiratory viruses that surge during certain seasons.
The FDA has authorized a new Novavax vaccine that uses a protein targeting method to protect against the Omicron variant, providing an alternative option to the mRNA vaccines by Moderna and Pfizer.
Moderna plans to advance a novel vaccine design targeting both flu and COVID-19 into its final stage of development, aiming to simplify annual vaccinations and increase vaccine uptake, with hopes of regulatory approval by 2025.
Moderna, Pfizer, and Novavax are racing to develop a combined flu and coronavirus vaccine, with Moderna reportedly jumping ahead with promising results from its phase 1/2 study.
