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FDA Authorizes Novavax’s Updated Covid Vaccine for Fall Rollout

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The U.S. Food and Drug Administration (FDA) has authorized Novavax’s updated protein-based Covid vaccine for emergency use in individuals aged 12 and older. This move clears the way for the vaccine to compete with Pfizer and Moderna’s shots in the upcoming fall and winter seasons.

The newly authorized Novavax vaccine targets the Omicron subvariant JN.1, which was prevalent in the U.S. earlier in the year, though it currently only accounts for 0.2% of cases. Despite the variant’s decline, Novavax assures that their vaccine provides robust protection against related strains that are now more dominant in the U.S., including KP.2.3, KP.3, KP.3.1.1, and LB.1.

Unlike the mRNA vaccines from Pfizer and Moderna, which can be rapidly updated, Novavax’s vaccine uses protein-based technology, a tried-and-tested method used in other vaccines like those for hepatitis B and shingles. This makes it an attractive alternative for individuals seeking non-mRNA options.

“We expect our updated vaccine to be broadly available across thousands of U.S. locations, including retail and independent pharmacies as well as regional grocers,” said Novavax CEO John Jacobs in a statement. The news boosted Novavax’s shares by over 8%.

This FDA approval follows last week’s green light for new mRNA vaccines from Pfizer and Moderna, which target a different offshoot of JN.1 called KP.2. Public health officials see the Novavax shot as a valuable option for those hesitant to use the newer mRNA technology.

However, it’s uncertain how many Americans will seek the new vaccines this fall, given that only around 22.5% of U.S. adults received the latest Covid boosters that were released last year.

Moderna Stock Plummets 20% After Lowering Guidance on EU Sales and U.S. Vaccine Market Challenges

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Moderna experienced a significant 20% drop in its stock price on Thursday after reporting second-quarter results that, while beating revenue expectations, prompted the company to sharply reduce its full-year sales forecast. The biotech firm now anticipates 2024 product revenue between $3 billion and $3.5 billion, down from its previous estimate of $4 billion.

The revised guidance is attributed to lower-than-expected sales in Europe, heightened competition in the U.S. vaccine market, and potential delays in international revenue. Moderna’s newly approved respiratory syncytial virus (RSV) vaccine, mRESVIA, began shipping in the U.S., but faces stiff competition from existing RSV vaccines by Pfizer and GSK.

Moderna CEO Stephane Bancel highlighted the increased competition for both RSV and Covid vaccines and noted difficulties in securing new contracts with European governments due to tight budgets and existing agreements with Pfizer and BioNTech. The ongoing conflict in Ukraine is also putting strain on government finances.

Despite the current challenges, Bancel expressed optimism for a recovery, projecting sales growth in 2025 and a break-even point by 2026, driven by new product launches.

For the second quarter, Moderna reported:

  • Loss per share: $3.33, better than the expected loss of $3.39
  • Revenue: $241 million, exceeding the $132 million forecast

Revenue from Moderna’s Covid vaccine fell 37% year-over-year, contributing to the company’s net loss of $1.28 billion. However, Moderna achieved a reduction in costs, including a significant drop in sales expenses and a 19% decrease in selling, general, and administrative costs. R&D expenses rose by 6% to $1.2 billion due to increased personnel costs.

Despite these setbacks, Moderna’s stock has risen nearly 20% this year, reflecting confidence in its pipeline and messenger RNA technology. The company is advancing 45 products in development, including a combination vaccine for Covid and flu, and a personalized cancer vaccine with Merck.