FDA aims to fully approve Pfizer-BioNTech's Covid-19 vaccine by Labor Day, global coronavirus cases surpass 200 million, and more in this week's roundup of Covid-19 news.

• Moderna on Thursday said its Covid-19 vaccine remains 93% effective against Covid-19 through six months post-vaccination, down only slightly from the 94.1% efficacy rate the company reported in November. However, despite the strong data for this time frame, the company said it believes antibody levels produced by the vaccine will "continue to wane and eventually impact vaccine efficacy," which—when considered with factures such as the delta variant, colder temperatures, and widespread pandemic fatigue—could increase the number of breakthrough infections among vaccinated people. "Given this intersection, we believe dose 3 booster will likely be necessary prior to the winter season," the company said. According to Moderna CEO Stéphane Bancel, the company will seek regulatory approval for a booster shot in September after analyzing data from current trials. So far, the company has reported that Phase 2 trials on booster shots have shown "robust" immune response against coronavirus variants, including delta and gamma. (Gonzalez, Axios, 8/5; Schwartz/Grossman, Wall Street Journal, 8/5; Sullivan, The Hill, 8/5)

• Novavax on Thursday said the federal government would not provide additional funding for its Covid-19 vaccine development until the company addresses federal regulators' concerns about its ability to mass manufacture the vaccine. While the company's vaccine candidate appears to have 90% efficacy rate against symptomatic Covid-19 cases—and 100% efficacy against severe disease—four people close to the situation said the company has not been able to demonstrate that its production process meets FDA's manufacturing standards. "The U.S. government has recently instructed the company to prioritize alignment with [FDA] on the company's analytic methods before conducting additional U.S. manufacturing and further indicated that the U.S. government will not fund additional U.S. manufacturing until such agreement has been made," Novavax said in an SEC filing. However, the company in a statement said it does not expect the situation to have "any impact on our funding arrangement with the U.S. government to support overall development and production of 110 million doses of our vaccine candidate." (LaFraniere, New York Times, 8/5; Weixel, The Hill, 8/5)
  
  

• The pandemic so far has resulted in more than 200 million coronavirus cases and 4.4 million deaths globally, Reuters reports, though experts caution the tallies could be short by millions given limited testing programs in certain nations._­ According to Reuters, it took a year to reach the first 100 million coronavirus cases worldwide, and only six months to reach the next 100 million. Currently, the United States, Brazil, Indonesia, India, and Iran are reporting the highest number of new cases on a weekly average. In particular, the United States now accounts for one in seven coronavirus infections reported globally as states with low vaccination rates—such as Florida and Louisiana—report record hospitalization numbers. (Lonas, The Hill, 8/4; Abraham/B, Reuters, 8/4)

• In a preprint study from Imperial College London, researchers collected swab tests from 98,233 people in England between June 24 and July 12; analyzed the samples through PCR testing; and found that fully vaccinated people are three times less likely to test positive for the coronavirus than unvaccinated people. In addition, the researchers found that people who were fully vaccinated were also 50% to 60% less likely to be infected with the delta variant—including asymptomatically—than those who were not vaccinated. Paul Elliot, director of Imperial College's Covid-19 REACT-1 Study, said, "These findings confirm our previous data showing that both doses of a vaccine offer good protection against getting infected. However, we can also see that there is still a risk of infection, as no vaccine is 100% effective, and we know that some double vaccinated people can still become ill from the virus." (Choi, The Hill, 8/4; Alford, Imperial College London news release, 8/4)

• FDA aims to issued fully approval for Pfizer-BioNTech's Covid-19 by the start of next month—with an unofficial deadline of Labor Day or sooner—several people familiar with the issue told the New York Times. President Joe Biden said last week that he expects a vaccine to be approved by "early fall," and an FDA spokesperson has said the agency has taken "an all-hands-on-deck approach" to the process, as full approval may boost public confidence in vaccination. According to the Times, several universities and hospitals, the Department of Defense, and the city of San Francisco are expected to enact vaccine mandates once a Covid-19 vaccine is fully approved. (LaFraniere/Weiland, New York Times, 8/3; Lonas, The Hill, 8/3)

• President Biden on Tuesday announced that the United States has shipped more than 110 million doses of Covid-19 vaccines to 65 countries, saying that the donations show "democracies can deliver," NPR's "Goats and Soda" reports. Around three-quarters of the doses were sent to COVAX, the World Health Organization's program for equitable vaccine access, and the remaining doses were shared directly with partners based on regional need. Biden also indicated the United States will soon begin exporting an additional 500 million doses of Pfizer-BioNTech's Covid-19 vaccines to low- and middle-income countries over the next year, the Wall Street Journal reports. But while the United States has currently donated more vaccines than every other country, Krishna Udayakumar, director of the Duke Global Health Innovation Center, said, "When the world needs 10 billion doses to get to where we need to go, it puts that in context. We're a hundred times off where we need to be." (Siddiqui, Wall Street Journal, 8/3; Keith/Stone, "Goats and Soda," NPR, 8/3)

• Heart problems following Covid-19 vaccination are rare and typically temporary, according to a new study published in JAMA Network. for the study, researchers analyzed more than two million medical records from patients who had received at least one dose of a Covid-19 vaccine and found 20 cases of myocarditis and 37 cases of pericarditis. According to the researchers, cases of both conditions were more likely to occur in men, and myocarditis was more often seen in younger patients, while the reverse was true for pericarditis. Patients who were hospitalized with these conditions tended to be discharged after a few days, the study found, and no deaths were reported. However, according to the New York Times, the incidence of myocarditis reported in the study—10 cases per 1 million vaccinations—is higher than CDC's current estimate of 4.8 per one million vaccinations, indicating that adverse events after vaccination may be underreported. That said, outside experts have noted that instances of heart problems are much more common in Covid-19 patients than vaccinated people. (Mandavilli, New York Times, 8/4)