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FDA Approves Updated Covid-19 Vaccines


The Food and Drug Administration (FDA) has given its approval for the updated Covid-19 vaccines developed by Pfizer and Moderna. This development paves the way for the vaccines to be made available at pharmacies as early as this week.

CDC Recommendation Pending

The final step in the regulatory process involves a recommendation from the Centers for Disease Control and Prevention (CDC), which is expected to be issued after a meeting of the CDC’s vaccine advisors on Tuesday.

Expanded Age Group Coverage

Targeting New Variant

The updated shots specifically target a variant known as XBB.1.5, which is currently not prevailing in the U.S. According to data provided by the companies, the vaccines also generate neutralizing antibody responses against EG.5.1 and BA.2.86, both of which are prevalent U.S. variants.

Hospital Admissions on the Rise

Recent reports from the New York Times indicate that the number of daily hospital admissions for Covid-19 positive cases is increasing in the U.S., rising by 29% in the past two weeks. It is important to note that these numbers are still lower than previous peaks during the pandemic.

Transition to a Commercial Market

This year’s rollout of Covid-19 vaccines signifies a significant shift toward a commercial market model. Previously, all vaccine doses were purchased by the federal government. It is now revealed that Pfizer and Moderna have set list prices for the shots between $110 and $130 per dose, though most insurance plans are expected to cover the costs without imposing copayments.

Covid-19 Vaccine Projections in the US

Relatively few Americans are expected to choose to take the Covid-19 vaccines produced by Moderna and Pfizer. Initially, both companies projected that the U.S. Covid-19 vaccine market would consist of 100 million doses this year. However, Moderna recently revised their projection to a range between 50 million and 100 million doses in early August. Pfizer has also been working to manage expectations.

If these estimates hold true, the number of Americans receiving the Covid-19 vaccines would be significantly lower than those who receive influenza vaccines each year. In the previous flu season, manufacturers distributed 173.4 million doses of flu vaccines in the U.S. By late April, approximately 47.4% of Americans had been vaccinated for the flu.

As a result of these developments, both Moderna and Pfizer, along with their partner BioNTech, have seen declines in their stock prices. Moderna stock has experienced a nearly 40% decrease since the beginning of the year, while Pfizer shares have fallen by 33%. Additionally, shares of Pfizer’s partner, BioNTech, have decreased by more than 20%. To address this situation, both companies are considering potential cost-cutting measures for their Covid-19 programs.

Analysts predict that Moderna will incur a loss of $3.92 per share this year and $5.11 per share next year, after having earned $20.12 per share in 2022.

A lingering question is whether the Centers for Disease Control and Prevention (CDC) will recommend the Pfizer and Moderna shots for everyone over the age of six months, as they have done in the past, or if they will provide more specific recommendations for older adults.

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