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.
Moderna's stock surged after the biotech company partnered with Carsgen to study a new cancer vaccine regimen using mRNA technology, giving Moderna a second opportunity in the field of cancer vaccines.
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.
The U.S. Centers for Disease Control and Prevention expects a new booster vaccine to be available next month, but its effectiveness against the highly mutated Pirola variant is uncertain.
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 vaccine has shown a strong immune response against the highly mutated omicron variant BA.2.86, suggesting that the vaccine will still be effective against newer variants of the virus.
The US FDA has approved new COVID booster shots from Pfizer and Moderna to address the omicron subvariant XBB.1.5, which could be available in the coming days pending CDC clearance.
The Centers for Disease Control and Prevention (CDC) is preparing to recommend COVID-19 booster shots for all Americans above 6 months of age, although not all vaccine experts agree on the necessity or benefits of these additional shots.
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 CEO Stéphane Bancel asserts that the positive data on the company's influenza vaccine and their plans to launch 15 products in the next five years demonstrate that they are not solely a Covid vaccine company.
Moderna's market cap took a hit after Pfizer's announcement that only 24% of eligible Americans will receive a COVID-19 booster shot, but analysts still project a positive outlook for the next five years with the company's expansion into other areas such as oncology and rare diseases. The target price for Moderna stock is $166.25 per share, indicating a potential upside of 59.67%.
The FDA has authorized Novavax's updated Covid vaccine for emergency use in individuals aged 12 and older, providing an alternative to mRNA shots from Pfizer and Moderna.
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.
Moderna is developing new refrigerator-stable vaccines that are easier to administer and do not require the same freezing conditions as previous COVID-19 vaccines, making them more accessible for use globally.
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 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.
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.
