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Moderna Submits FDA Approval for Newest COVID-19 Vaccine for Fall

Vials and medical syringes are displayed in front of the logos of the U.S. Food and Drug Administration and the biotech company Moderna.

Pablo Gonchar | Lightrocket | Getty Images

Moderna on thursday Application To gain U.S. Food and Drug Administration biotechnology company approval The latest novel coronavirus vaccine towards autumn.

shot target Omicron subvariant XBB.1.5the nationally dominant virus strain.

Moderna said the application is based on the FDA’s opinion. recommendation Last week, the vaccine maker announced it had updated its jabs targeting XBB.1.5, one of the most immune-evading novel coronavirus strains to date.

moderna and rival Faizand Novavax had already begun development of a vaccine targeting XBB.1 five months before the FDA’s recommendation.

All three companies plan to make the vaccines available to Americans in time for the fall, pending FDA approval.

“The agility of our mRNA platform will allow us to update Moderna’s COVID-19 vaccine, SpikeVax, to rapidly and clinically deliver the XBB variant,” said Stephan Bancel, CEO of Moderna, in a statement. “It’s now possible to target them more precisely.”

The FDA will review efficacy and safety data for the vaccine available to Moderna before deciding whether to approve it this fall.

Moderna announced last week that preclinical data in mice show that a monovalent vaccine targeting XBB.1.5 outperforms its approved bivalent vaccine targeting strains BA.4 and BA.5. suggest that it provokes a stronger immune response to the currently circulating XBB variant.

Clinical trial data in more than 100 people similarly demonstrate that the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All study participants had previously received four doses of the novel coronavirus vaccine.

The United States is expected to shift the distribution of COVID-19 vaccines to the private sector as early as this fall. That means Moderna, Pfizer and Novavax will be selling their latest Jabs directly to health care providers, not the government.

It’s unclear how many new people will be filming.

Only about 17% of the U.S. population has received the latest boosters from Pfizer and Moderna since they were approved in September, according to data from the U.S. Centers for Disease Control and Prevention.

Summarize this content to 100 words Vials and medical syringes are displayed in front of the logos of the U.S. Food and Drug Administration and the biotech company Moderna.Pablo Gonchar | Lightrocket | Getty ImagesModerna on thursday Application To gain U.S. Food and Drug Administration biotechnology company approval The latest novel coronavirus vaccine towards autumn. shot target Omicron subvariant XBB.1.5the nationally dominant virus strain. Moderna said the application is based on the FDA’s opinion. recommendation Last week, the vaccine maker announced it had updated its jabs targeting XBB.1.5, one of the most immune-evading novel coronavirus strains to date. moderna and rival Faizand Novavax had already begun development of a vaccine targeting XBB.1 five months before the FDA’s recommendation.All three companies plan to make the vaccines available to Americans in time for the fall, pending FDA approval.”The agility of our mRNA platform will allow us to update Moderna’s COVID-19 vaccine, SpikeVax, to rapidly and clinically deliver the XBB variant,” said Stephan Bancel, CEO of Moderna, in a statement. “It’s now possible to target them more precisely.” The FDA will review efficacy and safety data for the vaccine available to Moderna before deciding whether to approve it this fall. Moderna announced last week that preclinical data in mice show that a monovalent vaccine targeting XBB.1.5 outperforms its approved bivalent vaccine targeting strains BA.4 and BA.5. suggest that it provokes a stronger immune response to the currently circulating XBB variant. Clinical trial data in more than 100 people similarly demonstrate that the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All study participants had previously received four doses of the novel coronavirus vaccine.The United States is expected to shift the distribution of COVID-19 vaccines to the private sector as early as this fall. That means Moderna, Pfizer and Novavax will be selling their latest Jabs directly to health care providers, not the government.It’s unclear how many new people will be filming.Only about 17% of the U.S. population has received the latest boosters from Pfizer and Moderna since they were approved in September, according to data from the U.S. Centers for Disease Control and Prevention.
https://www.cnbc.com/2023/06/22/moderna-files-for-fda-approval-of-updated-covid-vaccine-for-fall.html Moderna Submits FDA Approval for Newest COVID-19 Vaccine for Fall

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