Moderna appears likely to get a thumbs up for its vaccine from the FDA advisory committee on Dec. 17. Other drug makers hope to get the same authorization for additional vaccines in the coming months, including a collaboration between Johnson & Johnson and BIDMC, led by Dan Barouch, MD, PhD (Center for Virology and Vaccine Research, BIDMC).

Boston Globe – December 11, 2020

FDA authorizes emergency use of first US vaccine for COVID-19

The Food and Drug Administration cleared the first COVID-19 vaccine in the United States for emergency use on Friday, a historic scientific achievement that came barely a year after the deadly novel coronavirus emerged and ran rampant around the world.

The emergency use authorization is for a two-dose vaccine developed by drug makers Pfizer and BioNTech that is expected to begin shipping immediately, once the US Centers for Disease Control and Prevention meets Sunday to issue the final clearance.

“The FDA’s authorization for emergency use of the first COVID19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” the agency’s commissioner, Stephen M. Hahn, said in a statement.

The agency acted in the hopes of controlling the pandemic in the United States, which leads the world in cases and deaths. The illness killed more than 3,000 Americans on Wednesday, the highest single-day death toll of the pandemic, and continues to upend life in the country. Now inoculations of high-risk groups could start as early as Monday.

The vaccine, which appeared to be 95 percent effective at preventing the illness in a late-stage study and caused no major side effects, has been authorized for people at least 16 years old. A second vaccine developed by Cambridge-based Moderna that uses the same cutting-edge technology is widely expected to receive the same authorization in a week or so.

The first recipients of the Pfizer-BioNTech vaccine in Massachusetts are expected to include health care workers and elderly residents of long-term care facilities. Boston hospitals are preparing to begin vaccinating their staffs as early as Tuesday, hours after the first shipment of frozen vaccines arrives from Pfizer’s manufacturing site in Kalamazoo, Mich.

The FDA authorization came the day after a panel of outside experts voted 17-4, with one abstention, to recommend that the agency clear it for emergency use.

Dr. Eric Rubin, chair of the department of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, who sits on the committee and supported emergency use, on Friday called the swift development and authorization an “incredible feat.”

He was relieved that the two-dose vaccine will soon be rolled out because the United States has done a poor job at preventing coronavirus cases through social distancing and mask-wearing, he said, and the country’s testing program has been inadequate.

“We’ve really been relying on a miracle to save us, and I hope this just might be our miracle,” Rubin said in an interview.

Pfizer and its German drug partner, BioNTech, smashed the record for the fastest developed vaccine in history — a mumps shot produced in four years in the 1960s is often cited as the previous record holder. BioNTech, a little-known biotech founded in 2008, began working on the vaccine in January and formed a partnership with Pfizer, the 171-year-old Fortune 500 powerhouse, a couple of months later.

As total US coronavirus-related deaths approach 300,000, Moderna appears likely to get a thumbs up for its vaccine from the FDA advisory committee on Dec. 17 and then the agency. Other drug makers hope to get the same authorization for additional vaccines in the coming months, including a collaboration between AstraZeneca and the University of Oxford and another between Johnson & Johnson and Boston’s Beth Israel Deaconess Medical Center.

Britain’s drug regulator gave its approval to the Pfizer-BioNTech vaccine on Dec. 2, and that country began inoculating people on Tuesday. Canada’s drug regulator took the same action on Wednesday, and vaccinations are expected to start next week.

Meanwhile in the US, approval did not come without politial fireworks, as is common in the Trump administration. Earlier Friday, as FDA staff were deliberating, the president lashed out and called the agency a “big, old, slow turtle.”

“Get the dam [sic] vaccines out NOW, Dr. Hahn,” Trump wrote in a Friday morning tweet,. The agency, which has sought to move quickly without eroding limited public confidence in vaccines, had originally planned to announce emergency use authorization on Saturday.

Trump’s chief of staff, Mark Meadows, called Hahn on Friday to complain about the agency moving slowly to make the announcement, according to a story first reported in the Washington Post. Meadows told Hahn that he may as well start looking for his next job if he didn’t get it done Friday, the newspaper said.

The White House is reportedly angry that Britain, not the United States, was the first nation in the West to roll out a COVID-19 vaccine. Trump has also complained the vaccine wasn’t authorized before Election Day, blaming it on a “Deep State” inside the FDA that he said was working against his reelection.

The Pfizer and Moderna vaccines rely on synthetic messenger RNA, a cutting-edge variation on the natural substance that directs protein production in cells throughout the body. The vaccines contain custom-made messenger molecules that instruct cells to create part of the coronavirus and then stimulate the immune system to make antibodies to fend off the disease if exposed to the actual virus. No mRNA vaccine has ever been approved.

The Massachusetts biopharma industry has played a key role in both vaccines.

Although Pfizer is based in New York, it has about 2,400 employees in Massachusetts, including about 1,400 at a manufacturing plant in Andover. That plant is one of three in the country helping to make components of the vaccine. BioNTech is based in Mainz, Germany, but has a small US headquarters in Cambridge.

Moderna is a homegrown company with 1,200 employees. Roughly half work at its Cambridge headquarters, while the rest work at a manufacturing plant in Norwood.

Governor Charlie Baker this week outlined a distribution plan that expects to provide 300,000 doses in the state by the end of the year, with the first phase including health care workers, elderly people in nursing homes, and police and emergency personnel. The first 60,000 doses are expected to reach Massachusetts around Dec. 15, Baker said.

But the governor’s plan hinges on critical factors outside the state’s control, including approval of more COVID-19 vaccines in addition to the two developed by Pfizer and Moderna, health officials said Thursday.

With the FDA’s authorization of the Pfizer-BioNTech vaccine, attention now turns to Pfizer’s massive distribution plant in Kalamazoo. About 350 large freezers there cover an area the size of a football field. The freezers are filled with stacks of trays that resemble pizza boxes, each box loaded with at least 195 glass vials. Each vial contains a few droplets of frozen coronavirus vaccine — enough, when thawed, to give five people the first shot in the two-dose regimen.

As soon as they get the word, Pfizer employees plan to pack the boxes into special containers and load them on to trucks. They will then be driven to airports and flown all over the country. The special containers will be filled with dry ice that keep the vials at minus-94 degrees Fahrenheit ― colder than the temperature on Mars ― so the vaccine inside doesn’t spoil.

Last month, Pfizer and its German partner, BioNTech, announced results showing that the vaccine, injected in two doses three weeks apart, was remarkably effective and safe in a late-stage trial of more than 43,000 volunteers. Half of the participants in the study received the vaccine, while the other half got a placebo. They then went about their daily lives, unaware of what they received.

On Nov. 18, the firms said that 170 people in the study had confirmed cases of COVID-19. Of those cases, 162 were among recipients of the placebo, compared with only eight cases among those who received the vaccine, which accounts for the 95 percent figure.

The vaccine appeared to be consistently effective regardless of age, gender, race, and ethnicity, and there were no serious safety concerns. The most significant adverse reactions were fatigue and headache, and they typically disappeared soon after the vaccinations. Older adults tended to report fewer and milder side effects, according to the companies.

The Trump administration has provided more than $12 billion to drug makers through the Operation Warp Speed program to speed development and distribution of coronavirus vaccines. Pfizer and BioNTech, unlike other drug makers, opted not to take any money up front. The government agreed to pay them $1.95 billion for at least 100 million doses once the vaccine got approved.

In the case of Moderna, the government has bankrolled the costs for developing the firm’s vaccine and pledged to buy at least 100 million doses, all for $2.48 billion. On Friday, Moderna announced that the government has exercised its option to buy an additional 100 million doses, bringing its total order so far to 200 million doses. The government has an option to buy an additional 300 million doses.