US FDA approves updated COVID shots ahead of fall and winter
Adds Novavax response in paragraph 11
By Mariam Sunny and Manas Mishra
Aug 22 (Reuters) -The U.S. Food and Drug Administration on Thursday approved updated COVID-19 vaccines made by Pfizer PFE.N and Moderna MRNA.O targeting a recent variant of the disease, in time for a fall vaccination campaign.
The updated shots target the KP.2 variant that was circulating earlier this year. They are expected to be available across the country in the coming days, the companies said.
The health regulator had asked vaccine manufacturers in June to target the variant, if feasible.
The latest vaccines are designed to more closely target currently circulating variants and better protect against the disease's severe symptoms. The older shots targeted a variant that is no longer circulating.
"Vaccination continues to be the cornerstone of COVID-19 prevention," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
KP.2 is no longer dominant but is still related to other variants currently circulating in the United States. Health regulators hope to protect against circulating variants by targeting closely related forms such as KP.2.
The FDA cleared the use of Moderna's shot, branded as Spikevax, and Comirnaty, which is jointly developed by Pfizer and BioNTech 22UAy.DE, in both children aged six months and older, and adults.
The shots for children below 12 years are cleared under the agency's emergency use authorization pathway.
The regulator did not approve a more traditional protein-based shot made by Novavax NVAX.O, which can offer an alternative to people skeptical of the mRNA vaccines made by Moderna and Pfizer.
Novavax said it was working "productively" with the FDA and expects to have authorization in time for peak vaccination season.
The company told Reuters it has been manufacturing the updated shots in anticipation of authorization for months.
Novavax's vaccine is developed in moth cells and takes months to manufacture. In 2023, for instance, the company said it needed six months to bring an adequate supply of the vaccine to the market.
The approvals come at a time when COVID-19-related hospitalizations and deaths have increased over the past three months in the United States. Demand for the shots, however, has fallen sharply since the peak of the pandemic.
Reporting by Manas Mishra, Mariam Sunny and Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar
Related Assets
Latest News
Disclaimer: The XM Group entities provide execution-only service and access to our Online Trading Facility, permitting a person to view and/or use the content available on or via the website, is not intended to change or expand on this, nor does it change or expand on this. Such access and use are always subject to: (i) Terms and Conditions; (ii) Risk Warnings; and (iii) Full Disclaimer. Such content is therefore provided as no more than general information. Particularly, please be aware that the contents of our Online Trading Facility are neither a solicitation, nor an offer to enter any transactions on the financial markets. Trading on any financial market involves a significant level of risk to your capital.
All material published on our Online Trading Facility is intended for educational/informational purposes only, and does not contain – nor should it be considered as containing – financial, investment tax or trading advice and recommendations; or a record of our trading prices; or an offer of, or solicitation for, a transaction in any financial instruments; or unsolicited financial promotions to you.
Any third-party content, as well as content prepared by XM, such as: opinions, news, research, analyses, prices and other information or links to third-party sites contained on this website are provided on an “as-is” basis, as general market commentary, and do not constitute investment advice. To the extent that any content is construed as investment research, you must note and accept that the content was not intended to and has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such, it would be considered as marketing communication under the relevant laws and regulations. Please ensure that you have read and understood our Notification on Non-Independent Investment. Research and Risk Warning concerning the foregoing information, which can be accessed here.