On May 27th local time, Robert F. Kennedy Jr., Secretary of the U.S. Department of Health and Human Services (HHS), announced that routine COVID-19 vaccination will no longer be recommended for healthy children and pregnant women.
The U.S. Centers for Disease Control and Prevention (CDC) previously recommended that all infants 6 months and older should be vaccinated against the new coronavirus.
Just a week ago, the U.S. Food and Drug Administration (FDA) announced that the agency plans to limit the use of the new crown vaccine to the elderly, children and adults with underlying medical conditions.
The FDA last week released new regulatory guidance for future COVID-19 vaccine boosters, setting stricter approval standards for vaccination of healthy Americans.
The FDA said that vaccines developed against new variants need to be re-approved before they can be marketed. Previously, the FDA usually approved the new crown vaccine for vaccination in all Americans every year based on simple test results (indicating that the vaccine can induce a strong enough antibody response).
According to a recent paper published in the New England Journal of Medicine, the FDA recommends using different evidence standards to approve vaccines based on the risk of patients developing severe illness after being infected with the new coronavirus.
The FDA stated in the paper: "The FDA's new management philosophy for the COVID-19 pandemic reflects a balance between regulatory flexibility and a commitment to gold standard science. The FDA will approve vaccines for high-risk groups while requiring reliable gold standard data for low-risk groups."
If the new strain vaccines from Pfizer and Moderna are considered products that need to be re-submitted for marketing verification, then there may not be an upgraded version of the COVID-19 booster vaccine available in the United States this fall.
The new requirement would also mean higher costs for pharmaceutical companies and could limit the number of people who can receive new vaccines each year.
In this regard, BMO Capital Markets analyst Evan Seigerman said in a report released last week that if the new guidelines are widely implemented, revenue for COVID-19 vaccine manufacturers such as Pfizer , BioNTech and Moderna may decline slightly.
The FDA's vaccine advisory committee will meet Thursday to make recommendations on which strains should be included in the next round of vaccinations.
Earlier this month, the FDA limited use of the newly approved Novavax COVID-19 vaccine to people 65 and older and teenagers and adults with at least one medical condition that could cause severe illness.
So far this year, Moderna's stock price has fallen by more than 35%; Pfizer's stock price has fallen by more than 11%; and BioNtech's stock price has fallen by nearly 14%.
Experts say that although the number of COVID-19 hospitalizations and deaths in the United States and around the world has dropped significantly, the virus is still spreading.
Currently, the United States is closely monitoring the spread of Omicron's latest variant, LP.8.1, which accounts for 70% of COVID-19 cases in the United States as of May 10.

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