The Health 202: Moderna’s coronavirus vaccine expected to be approved by end of this week

The same panel of experts that recommended Pfizer’s vaccine last Thursday will consider Moderna’s vaccine tomorrow. If things unfold the same way, the advisory committee to the Food and Drug Administration will vote at the end of the day tomorrow to recommend the vaccine. 

And just like last week, the FDA is likely to authorize the two-shot regimen as soon as Friday, a person with knowledge of the situation told our colleagues Carolyn Y. Johnson and Karin Brulliard.

In a detailed review posted yesterday, the FDA said its vaccine was “highly effective” in a clinical trial and carried no serious safety concerns. Agency reviewers said the regimen was 94 percent effective at preventing diseases in the trial and particularly effective against severe disease. Thirty trial participants got severe covid-19 – and all of them had received the placebo, not the vaccine.

They also confirmed the vaccine worked well in both men and women and people of all ages and races. Side effects were widespread but typically short-lived and bearable. They included fatigue, headaches, muscle aches and pain at the injection site.

Paul Duprex, director of the Center for Vaccine Research at the University of Pittsburgh, predicted the Moderna vaccine would be authorized soon because it looked effective and safe. That vaccine’s simpler logistics are also an advantage, he told Carolyn and Karin. 

It doesn’t require specialized, ultracold storage conditions like the ­Pfizer doses. “I like the fact that now we have something that can be stored in a minus-20 [degrees Celsius] fridge — the same kind of fridge you keep your ice cream in,” Duprex said.

This question – of whether the vaccines protect people from carrying the virus – is a major outstanding question for scientists. If they do, that could allow people to stop wearing and social distancing sooner. 

“Data filed by Moderna suggested the vaccine might prevent asymptomatic infections, not just symptomatic cases of disease,” Carolyn and Karin write.

“In an addendum Moderna filed to the FDA, the company presented a tantalizing hint: Upon receiving their second dose of vaccine or placebo, 52 people tested positive for the coronavirus without symptoms. Most of those people were in the placebo group, indicating the vaccine may have protected participants who received the vaccine against asymptomatic infection.”

Still, the FDA review noted the data were limited and called for further studies.

Ashish K. Jha, dean of the Brown University School of Public Health:

Moderna’s vaccine was developed in partnership with the National Institute of Allergy and Infectious Diseases. Like the Pfizer vaccine, it uses messenger RNA technology, a new genetic vaccine innovation that could serve as a model for the rapid creation of vaccines against other diseases.

Moncef Slaoui, head of Operation Warp Speed, the federal vaccine effort, told MSNBC that between the Pfizer and Moderna vaccines the country remains on track to immunize 20 million people in December. Slaoui said he expects the initial shipment of Moderna’s vaccine to go to about 3,200 sites. 

People familiar with the situation told the New York Times that the administration could use its power to free up supplies of raw materials to help Pfizer produce tens of millions of additional doses in the first half of next year. 

“The administration recently asked Pfizer to sell it enough doses to cover an additional 50 million Americans, but Pfizer said it had already found customers around the world for all the doses it can produce until around the middle of next year,” the Times writes.

“In recent days, however, Pfizer has indicated that it would be able to manufacture more doses if the administration orders the company’s suppliers to prioritize its purchase requests. The two sides are now negotiating a contract under which Pfizer would provide tens of millions more doses from April to the end of June.”

Germany and the Netherlands have both announced school closures as the countries enter stricter shutdowns aimed at quelling coronavirus outbreaks. In London, Mayor Sadiq Khan called on British Prime Minister Boris Johnson on Monday to close the city’s secondary schools, saying that they were responsible for a significant share of infections in the city.

“The school closures in Germany and the Netherlands mark a notable turnaround in Europe, where governments said this fall that keeping schools open would be a priority, arguing that they aren’t significant drivers of coronavirus outbreaks,” Rick Noack reports.

Unlike the United States, where many areas saw schools close even as bars and restaurants stayed open, Europe’s closures come as a last-resort measure amid nationwide shutdowns.

Studies suggest that coronavirus spreads less readily among children. A recent 40,000-person study in Iceland that used contact tracing and genetic sequencing to identify links among coronavirus outbreak clusters found that children under 15 were half as likely to spread the virus as adults, with younger children even less so.

Still, researchers warn that transmission can occur in schools, especially among older children. 

“You should sacrifice a lot to be able to keep schools open because they are so important for children,” said Kari Stefansson, CEO of Icelandic biopharmaceutical company Decode Genetics and a researcher involved in the study of transmission among children. “But you have to do so cognizant of the fact that you’re sacrificing something.”

“The first Covid shots will soon be available to top officials and essential staff in the White House, the Pentagon and Congress. But they’re already facing a political and ethical dilemma over who should be at the front of the line,” Politico’s Alice Miranda Ollstein reports.

While most of the first round of Pfizer vaccines is going to health-care workers and nursing home residents, some of the scarce supplies have been set aside for federal leaders so the government can continue to function. Now, members of Congress, President Trump and President-elect Joe Biden must decide when they will be vaccinated.

Some members of Congress have already said that they don’t want to be seen as pushing ahead to get the vaccine.

“I will not skip the line,” Senate Minority Leader Chuck Schumer (D-N.Y.) said during a floor speech Monday. But “as soon as it’s appropriate and recommended,” he added, “We should all lead by example, take the vaccine and tell our constituents to take it as well.”

Officials will also need to decide how to prioritize vaccinations in the federal bureaucracy. Top officials in charge of homeland security, nuclear deterrence and cybersecurity are thought to be first in line, while staff at agencies like the FDA who are mostly working remotely may not get priority.

“In an ideal world you’d have people in both parties line up and say, ‘We’re getting this vaccine and we think you should too,’ ” former Centers for Disease Control and Prevention director Tom Frieden told Politico. “But right now the only people who can get it are health-care workers and people living in nursing homes. You don’t want to gin up demand before you get supply.”

Transition members worry that coronavirus vaccines could become politicized in much the same way that masks have been, leading to some behind-the-scenes concerns that Republicans could foment opposition to the shots. “Health policy experts say Biden’s capacity to mold bipartisan receptivity to being vaccinated has implications for his broader agenda to expand health coverage and access to affordable care,” Amy Goldstein reports.

Robert J. Blendon, a professor of health policy and political analysis at Harvard University, says GOP politicians have not indicated that they will take a wholesale stand against coronavirus vaccines, but they may emulate Trump in rejecting a strong federal role in setting pandemic policy, possibly leading to fights over who distributes the vaccine and whether there should be vaccine requirements for people to return to work or school.

Biden put in place his 13-member coronavirus advisory board less than 48-hours after he clinched the election. People familiar with the campaign say that the three advisory members have already divided responsibilities: “Surgeon General-designee Vivek H. Murthy is focusing mainly on improving coronavirus testing and the supplies of personal protective equipment. Marcella Nunez-Smith, named to lead the new equity task force, has been focused on global equity issues. And [former FDA commissioner David] Kessler, one of the people under consideration to lead the FDA again, is working primarily on vaccines,” Amy writes. 

“The test could be a vital tool in the country’s fight against the virus — especially in the months before most Americans are vaccinated. Unlike previous home tests, this version does not require samples to be sent to a lab and can be taken without doctor’s orders by anyone older than 2,” William Wan reports.

The test from Australian company Ellume is one of several signs that the country is on the cusp of a rapid increase in testing capacity in the coming two to three months, according to experts. But Ellume’s initial supply of 100,000 tests is unlikely to meet demand. The company has said it plans to increase manufacturing to 1 million by the middle of 2021.

The test will require users to download an app, which will send data by Zip code to regional health officials. The feature addresses a major concern of health experts who have warned that the rise in testing outside of a lab is leaving health officials in the dark about the number of positive cases.