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Moderna's covid-19 vaccine was 93% effective against symptomatic disease over six months, and the company hopes to complete its application for full approval from the US Food and Drug Administration this month, the company said Thursday.
The efficacy data comes from a final analysis of the Phase 3 study of the vaccine, which recruited thousands of participants who received both doses last year, before it was made available to the general public.
"In the final analysis" of the study, "Moderna's vaccine against covid-19 showed 93% efficacy, and efficacy was maintained for six months after the second dose was administered," Moderna said in a statement from press.
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Data reflecting 93% efficacy was from trial participants who had been fully vaccinated on November 25 and evaluated for the next six months, before the highly contagious delta variant became dominant in the United States and fueled the current surge. of cases.
"We are pleased that our COVID-19 vaccine shows a long-lasting 93% efficacy for six months, but we recognize that the delta variant is a major new threat, so we must remain vigilant," said Moderna CEO Stéphane. Bancel, in the press release.
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Last month, the makers of the other licensed mRNA vaccine in the United States, Pfizer / BioNTech, released efficacy data showing a six-month overall efficacy of 91%, with a possible decline towards the end of that time.
Like the Moderna data, the Pfizer tracking data was collected prior to the delta-related surge.
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Pfizer's pre-printed paper showed that the efficacy of its vaccine, in a trial involving 44,000 volunteers worldwide, peaked by more than 96% between one week and about two months after a second dose, and then it seemed to gradually decline to 83.7% four to six months later, according to the article, which had not yet been peer-reviewed or published in a journal.
Moderna Says Boosters May Be Needed Before Winter
Moderna believes the delta variant will lead to more major infections and boosters may be needed before winter, according to slides released ahead of the company's earnings call Thursday.
"We believe that increased infection strength resulting from delta, non-pharmaceutical intervention (NPI) fatigue, and seasonal effects (moving indoors) will lead to increased infections in vaccinated people," says one of the slides. .
Moderna also said that while she sees lasting efficacy from the vaccine, she expects neutralizing titers to continue to decline and eventually impact the efficacy of the vaccine.
"Given this intersection, we think Booster Dose 3 will likely be needed before the winter season," reads a slide.
Moderna is awaiting dose data before applying for an emergency use authorization (US) for a booster vaccine, Moderna president Dr. Stephen Hoge said in Thursday's investor call.
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The first two doses of Moderna are 100 micrograms each.
The company says it is exploring whether a booster, a third injection of the same vaccine, should be 50 micrograms or 100 micrograms.
"We believe that our clinical data at this time supports a 50 microgram boost ..." said Hoge.
"But we will wait for the 100 microgram data in the coming weeks to confirm the selection of the 50 microgram booster dose before presentation."
In Thursday's call, Hoge presented the first data, which has not yet been peer-reviewed, showing that the vaccine's neutralizing antibodies decline six months after the second dose, even against the delta variant.
Hoge said that data that has not yet been peer-reviewed showed that 14 days after a 50-microgram boost was given, antibody titers rose significantly.
Hoge called this "very encouraging," adding that the company believes this confirms its selection of the boost as likely protective against circulating variants of concern, particularly delta.
Experts have said that it is unclear how these antibody levels correlate with real-world immunity and to what extent other parts of the immune system, such as T cells, might influence protection.
Pfizer said in an investor call last week that it intends to submit a reinforcement for the EUA's consideration beginning in August.
The FDA and the U.S. Centers for Disease Control and Prevention (CDC) said at the time that Americans didn't need a third dose yet, and that it wasn't just up to companies to decide when a dose might be needed. additional.
Dr. Francis Collins, director of the National Institutes of Health, told CNN on Tuesday: "At this time ... the data in the United States does not indicate that (a booster) is necessary."
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In July, the maker of the third licensed Covid-19 vaccine in the United States, Johnson & Johnson, said its one-dose product provides immunity that lasts for at least eight months and appears to provide protection against the delta variant.
On Tuesday, the San Francisco Department of Public Health announced that it would provide people who received the Johnson & Johnson single-dose vaccine with a supplemental dose of an mRNA vaccine, either Pfizer or Moderna.
I would give these supplementary doses to those who have previously consulted with their doctor.
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said Tuesday that "the FDA does not recommend taking things into your own hands" regarding booster shots of the vaccine.
"You can see by looking at the news that there are people and jurisdictions that are really taking things into their own hands ... The FDA does not recommend taking things into their own hands," Marks said in a discussion hosted by the Project's briefing. of Education and Equity on Covid-19 Vaccines.
The San Francisco health department maintains that it aligns with the CDC and the FDA.
"We are not recommending; we are accommodating requests," said Dr. Naveena Bobba, SFDPH's deputy director of health, at a news conference Tuesday.
"We have received some requests based on patients who speak with their doctors and that is why we allow adaptation."
CNN's Jacqueline Howard contributed to this report.
Modern vaccine against covid-19
