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July 1, 2022

Covid-19 roundup: FDA recommends fall boosters target BA.4 and BA.5

Daily Briefing

    A study finds that women are twice as likely as men to be diagnosed with long Covid, Covid-19 vaccines prevented nearly 20 million deaths last year, and more in this week's roundup of Covid-19 news.

    Your top resources on the Covid-19 vaccines

        • The Biden administration announced on Wednesday that it will pay $3.2 billion for 105 million doses of Pfizer-BioNTech's updated Covid-19 vaccine for the United States' fall vaccination campaign. When given as a fourth booster dose, the bivalent omicron-modified vaccine, which combines an omicron-modified vaccine with the original Covid-19 vaccine, increased participants' neutralizing antibodies between 9.1 times and 10.9 times against the omicron variant. According to HHS, the new vaccine is expected to arrive in the early fall. "We look forward to taking delivery of these new variant-specific vaccines and working with state and local health departments, pharmacies, health care providers, federally qualified health centers, and other partners to make them available in communities around the country this fall," said Dawn O’Connell, HHS' assistant secretary for preparedness and response. However, Ashish Jha, the White House Covid-19 response coordinator, said the current order "will not purchase enough vaccines offer one of these new booster shots to every adult and unfortunately, comes at the expense of continued funding for other critical pandemic response needs like testing manufacturing and domestic vaccine manufacturing." (Sullivan, The Hill, 6/29; Restuccia/Hopkins, Wall Street Journal, 6/29)
        • Women are at least twice as likely as men to be diagnosed with long Covid, according to a study from genetic testing company 23andMe. For the study, researchers analyzed data from more than 100,000 individuals who reported having had Covid-19. Of these patients, more than 26,000 reporting experiencing symptoms of long Covid, and over 7,000 reported being diagnosed with the condition. Overall, 78% of patients who had been diagnosed with long Covid were women, and 21% were men. In addition, women with long Covid appeared to have longer lasting symptoms, including disruptions to their menstrual cycles, than men with the condition. According to the researchers, the higher rate of long Covid among women suggests that differences in hormonal levels may play a role in the condition's development. "Projecting over the millions of individuals worldwide who've been infected or are yet to be infected, the public health impact of long COVID is likely to linger for years to come," the researchers wrote. "Understanding the underlying biology and associations may help as scientists wrestle with the best way to treat the condition." (Weldon/Aslibekyan, 23andMe, 5/24; Leech, Bizwomen, 6/17)
        • Covid-19 vaccines prevented almost 20 million deaths between December 2020 and December 2021, according to a new study published in The Lancet Infectious Diseases. For the study, researchers modeled the spread of the coronavirus in 185 countries to estimate the impact of vaccines after they were first introduced in December 2020. Overall, the researchers found that Covid-19 vaccines helped prevent 19.8 million deaths between December 2020 and December 2021, including 1.9 million in the United States alone. Around 80% of these potential deaths were prevented primarily due vaccines, while indirect protection through collective vaccination helped prevent 4.3 million deaths. According to the researchers, the study highlights the "substantial impact that vaccines have had and the millions of lives that are likely to have been saved during the first year of vaccination." However, they noted that more lives likely could have been saved if Covid-19 vaccines had been distributed more equitably around the world. For example, if the World Health Organization's target of vaccination 40% of the global population by the end of 2021 had been reached, around 600,000 additional deaths could have been prevented. "Vaccine distribution and delivery infrastructure also needs to be scaled up worldwide and misinformation combatted to improve vaccine demand," the researchers wrote. (Chen, Axios, 6/23; AP/Modern Healthcare, 6/24; Muthukumar, STAT News, 6/23)
        • Infants under six months whose mothers were vaccinated against the coronavirus had a lower risk of being hospitalized from Covid-19, according to a study published in the New England Journal of Medicine—however, this protection was reduced during the omicron period. For the study, researchers examined infants who had been hospitalized for Covid-19 and those who had been hospitalized for other conditions between July 1, 2021, and March 8, 2022, at 30 hospitals in 22 states. Overall, the researchers found that 16% of infants hospitalized with Covid-19 were born to mothers who had been vaccinated, compared with 29% of infants who had been hospitalized for other conditions. Based on this data, maternal vaccination was estimated to be 52% effective against Covid-19 hospitalization among infants and 70% effective against ICU admission. "The finding that the risk of hospitalization, and in particular, hospitalization in an ICU, was reduced among infants whose mothers had been fully vaccinated during pregnancy provides evidence of additional benefits of maternal vaccination beyond those previously reported for the mother," the researchers wrote. However, maternal vaccination was associated with lower protection during the omicron period (38%) than the delta period (80%). Still, the researchers noted that even this "moderate" reduction in hospitalization risk during the omicron period is still meaningful since children under six months are not eligible to be vaccinated against Covid-19. Currently, Covid-19 vaccines have only been authorized for children six months and older. (D'Ambrosio, MedPage Today, 6/22)

           

        • FDA on Thursday announced it is advising Covid-19 vaccine manufacturers to specifically target the BA.4 and BA.5 omicron subvariants in their vaccine formulations for the fall. The agency added that the original Covid-19 vaccines will still be used for patients who need their first series of shots, but booster shots for the fall will combine the original vaccine with a vaccine designed to specifically protect against BA.4 and BA.5, which now account for just over half of all Covid-19 cases in the United States. The decision follows FDA's Vaccines and Related Biological Products Advisory Committee recommendation that fall boosters somehow target omicron but left undecided the specific formulation. "As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research. John Moore, a professor of microbiology and immunology at Weill Cornell Medicine, said he believes FDA is "making a best guess as to what they think is the right thing to do, and that may turn out to be a good one and it might not. We don't know and have no real way of knowing." (Weiland, New York Times, 6/30; Neergaard/Perrone, Associated Press, 6/30; Johnson, Washington Post, 6/30)

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