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: Moderna's updated COVID-19 vaccine shows efficacy against omicron subvariants.
Key points:
1. Moderna's updated COVID-19 vaccine boosts neutralizing antibodies against omicron subvariants EG.5 and FL.1.5.1.
2. The booster shot is expected to be authorized and rolled out soon.
3. The preliminary trial data aims to reassure concerns about the vaccine's effectiveness against current variants.
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.
Novavax shares have surged over 20% this month due to the increase in COVID cases in the US, driven by the dominant EG.5 variant, although the impact of the highly mutated BA.2.86 strain remains uncertain.
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.
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.
Afrigen Biologics and Vaccines, a South African pharmaceutical firm, has made significant progress in developing an mRNA vaccine against COVID-19, potentially expanding access to vaccines globally and enabling lower-income countries to produce their own mRNA vaccines.
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 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.
Moderna has announced positive results from a Phase 1/2 clinical trial of its combination vaccine, mRNA-1083, against both influenza and Covid-19, revealing strong immune responses and safety, with a Phase 3 trial planned for this year for adults aged 50 and older.
The FDA has approved an updated version of the Novavax COVID-19 vaccine, which is effective against Omicron strains and may have fewer side effects compared to mRNA vaccines.
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, 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.
Vaccine maker Novavax has shipped millions of doses of its updated COVID-19 shots to distributors after receiving clearance from U.S. regulators, with the shots expected to be available at U.S. pharmacies this week.
The European Union regulators have postponed their decision on approving Novavax's variant-specific COVID-19 vaccine due to the need for more information on its potency and consistency among different production sites.
