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Authorization of Johnson & Johnson vaccine could accelerate US immunization

This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the Janssen COVID-19 vaccine in the United States. On Thursday, Feb. 4, 2021, Johnson & Johnson has asked U.S. regulators to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies. (Johnson & Johnson via AP)
This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the Janssen COVID-19 vaccine in the United States. On Thursday, Feb. 4, 2021, Johnson & Johnson has asked U.S. regulators to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies. (Johnson & Johnson via AP)
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A third coronavirus vaccine could be available to Americans within weeks after Johnson & Johnson submitted its shot to the Food and Drug Administration for emergency use authorization Thursday, and experts say it could greatly improve the nation’s prospects for containing the pandemic in the coming months.

“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, in a statement Thursday.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet Feb. 26 to review clinical trial data and debate whether to recommend authorization. The agency will make background materials available to the public in advance, and the meeting will be streamed live, as the reviews of previous vaccine candidates were.

“The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines,” said acting FDA Commissioner Janet Woodcock.

Pfizer and Moderna’s vaccines, which require two shots several weeks apart, were both approved within days after the VRBPAC met to recommend authorization. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices also needs to meet to develop guidance before a vaccine is distributed. That timeline suggests the Johnson & Johnson vaccine would not be administered to the public until at least early March.

If the vaccine is authorized, the company has said some doses would be ready for shipment immediately. Johnson & Johnson has committed to providing the U.S. with 100 million doses by the end of June, with the option to purchase additional doses.

“Every option is on the table to accelerate manufacturing in the event that the FDA does approve the Johnson & Johnson vaccine,” Andy Slavitt, one of President Joe Biden’s senior coronavirus advisers, told reporters Friday.

According to Johnson & Johnson, initial data from its Phase 3 clinical trials shows the vaccine was 66% effective overall in preventing moderate to severe COVID-19 infections 28 days after administration, with protection observed as early as Day 14. It was 85% effective in preventing severe disease, and no reported infections resulted in hospitalization or death.

The trials indicated some disparities in protection against variants of the virus, with a 72% rate of effectiveness against moderate to severe illness in the U.S., 66% in Latin America, and 57% in South Africa. Most of the cases in South Africa were linked to a variant that is believed to be more transmissible and less vulnerable to antibodies.

“The good news is, when you look across all of the countries, the protection against severe disease was well over 80%,” Dr. Anthony Fauci, the federal government’s top infectious disease expert, said Friday.

Protection was generally consistent across races and age groups in international trials, which included nearly 44,000 participants. Additional research is being done on a two-dose version of the vaccine, but results will not be available for several months.

“We all hope that after careful review of the trial results by the FDA that emergency use authorization is justified. This vaccine has the potential to reduce mortality, hospitalizations for serious infections and vaccinate up to 100 million Americans by the summer,” said Jeffrey Carson, a professor of medicine at Rutgers University and principal investigator for one of Johnson & Johnson’s Phase 3 trials.

If the FDA review confirms the company’s claims about the safety and efficacy of its vaccine, experts say it is highly likely to receive emergency use authorization.

“The benefits significantly outweigh the risks, based on what I see here,” said Dr. Johan Bester, director of bioethics at UNLV School of Medicine.

As with the other vaccines that have received authorization, it is unclear if the Johnson & Johnson shot prevents asymptomatic infection or if those who have been vaccinated can still transmit the virus to others. The rapid timeline for development has also left questions about how long protection will last and whether booster shots will be necessary down the line, but those are challenges that can be addressed later.

“This shouldn’t scare us,” said Dr. Arnold Monto, an epidemiologist at the University of Michigan who chaired the VRBPAC meetings on the Pfizer and Moderna vaccines in December. “We’ve dealt with this situation with influenza for years.”

In addition to requiring only a single shot, the Johnson & Johnson vaccine would also be easier to store than Pfizer and Moderna’s, remaining stable at regular refrigerated temperatures for up to three months. However, it appears to be somewhat less effective, as well.

Pfizer’s Phase 3 trial data showed its vaccine was 95% effective in preventing symptomatic infection after two doses, and Moderna’s was 94.1% effective. The three trials were conducted differently, though, making direct comparisons difficult, and Pfizer and Moderna’s drugs were tested before the more transmissible variants emerged.

“It's like comparing apples to mangos,” said Dr. Angela Shen, a visiting research scientist at the Children’s Hospital of Philadelphia Vaccine Education Center. “J&J looked at preventing moderate to serve COVID illness while the other vaccines looked at preventing symptomatic COVID. The key takeaway is that all these vaccines have eliminated deaths and reduced hospitalizations.”

According to the CDC, nearly 57.5 million doses of the Pfizer and Moderna vaccines have been distributed in the U.S., as of Thursday afternoon, with 35 million doses administered. Nearly 7 million Americans have received two doses.

The pace of vaccination is improving, but the totals are still far short of where federal health officials hoped the process would be nearly two months after the first vaccine received authorization. White House officials say they have already increased the supply of vaccines to states by 20% since Jan. 20.

About 1,000 active-duty troops are now being deployed to FEMA vaccination sites in five states to assist with distribution. The Biden administration also announced Thursday it is developing guidance for adapting vaccines, drugs, and tests for variants of the coronavirus.

Experts say authorization of the Johnson & Johnson vaccine could provide a significant boost to the nation’s efforts to achieve herd immunity against the virus. A vaccine that is easier to store and able to be administered in a single dose would vastly simplify the logistics of distribution.

“It should get us there a lot faster,” said Dr. William Paul McKinney, a professor and associate dean at the University of Louisville School of Public Health and Information Sciences and a member of the Louisville Metro COVID-19 Vaccine Distribution Task Force. “For one thing, the vaccine will be easier to distribute to more remote areas.”

According to Shen, introducing a single-shot vaccine could be “instrumental” in accelerating immunization. The 100 million doses Johnson & Johnson aims to deliver would join 200 million doses each of Pfizer and Moderna’s shots that are expected to be available by July, potentially giving the U.S. the capacity to vaccinate 300 million people.

“We are approaching a scenario where there will be more supply than demand—the reverse of what we have now,” Shen said. “This will change everything.”

Since the initial data does not indicate how effective the Johnson & Johnson vaccine is in preventing mild or asymptomatic infection, Bester stressed it might not confer total immunity. Still, even if all it does is reduce hospitalization and death, that would be a major advance toward containing the pandemic.

“Herd immunity is obviously a great goal...,” he said, “but the first step we want to get to, an extremely important outcome is we want to stop people from getting seriously ill.”

Several other vaccine candidates are in late Phase 3 trials or have already been approved in other countries. Some could seek U.S. authorization in the coming weeks and months, but they have not yet collected sufficient data to satisfy FDA guidelines.

“I thought we’d be closer to those endpoints right now,” McKinney said.

A two-dose vaccine developed by AstraZeneca and researchers at Oxford has been approved in Europe, the United Kingdom, and India, but the company has not submitted it for emergency authorization in the U.S. The vaccine has shown an efficacy rate of 82.4% in preventing illness, with some signs that it also reduces transmission.

Novavax has reported 89.3% efficacy in a U.K.-based clinical trial, but data from South Africa suggests its two-dose vaccine is less effective against the prevalent variant there. If the company’s vaccine is successful, it expects to provide 100 million doses to the U.S. this year.

A new trial launched Thursday in the United Kingdom will examine the effectiveness of giving patients one dose of AstraZeneca’s vaccine and one dose of Pfizer’s at a variety of time intervals. The CDC has said the Moderna and Pfizer vaccines can be mixed in “exceptional situations.”

No matter how many doses of vaccines are produced and distributed, hesitancy remains an obstacle. Experts estimate at least 70% of the population or more will need to be immunized to stop the spread of the virus, and that could prove difficult to achieve even when supply is no longer an issue.

Although overall willingness to get vaccinated has risen in recent months, a survey released by the National Foundation for Infectious Diseases this week found only half of Black adults plan to get vaccinated, and distribution among Black and Latino Americans is lagging in many states. Many health care workers have also been reluctant to take the vaccine when offered to them, and partisan divisions over whether to get vaccinated are growing.

Public health officials have struggled to overcome those sentiments, some of which are rooted in historic inequities and mistreatment. As they touted promising data on Johnson & Johnson’s vaccine Friday, Biden administration officials delivered an unequivocal message that anyone who can get a vaccine should do so as soon as possible.

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“The message we have, when a vaccine becomes available to you, get vaccinated,” Fauci said. “You will not only be protecting yourself, your family, but you will be making a major step in a positive way to protecting the community.”

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