FDA greenlights Moderna vaccine as next shipment of Pfizer vaccine is reduced by nearly 30 percent

Gov. Baker “frustrated” by the allotment cut, but unsure of long-term impact

A nurse prepared a Pfizer-BioNTech Covid-19 vaccine.Micah Green/Bloomberg

Federal regulators Friday night cleared Moderna’s powerful new COVID-19 vaccine for emergency use, helping Massachusetts and other states offset the first bump in the national vaccination rollout: a cut in the number of vaccines made by Pfizer that states will receive this month.

One week after Pfizer’s vaccine won emergency use authorization, the Food and Drug Administration added the new vaccine made by Cambridge-based Moderna to the US arsenal in the battle against COVID-19, which has killed 11,358 Massachusetts residents and more than 300,000 Americans.

The move caps a stunning nine-month sprint to develop the first vaccines against a raging pandemic — and gives validation to 10-year-old Moderna, part of the fast-growing biopharmaceutical cluster that has taken root in Cambridge’s Kendall Square.

FDA officials cleared Moderna’s vaccine, based on a novel messenger RNA technology, for people 18 years and older.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn.

Moderna chief executive Stephane Bancel said he was proud of the company’s scientific achievement. “We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” he said in a statement Friday night.

But the milestone came against a backdrop of a troubling supply chain glitch that federal officials couldn’t immediately explain. State leaders said they could not be sure if Pfizer’s reduction from 60,000 to 42,900 doses in its next few shipments to Massachusetts was a temporary hiccup or a sign of broader supply shortages to come. The next shipment of Pfizer vaccines is going to CVS and Walgreen’s, the pharmacy companies that will be vaccinating residents and staff at nursing homes and other long-term care sites.

Pfizer and federal health officials, for their part, denied vaccine production or distribution had been scaled back.

Officials at the state’s Command Center, which handles its response to the coronavirus crisis, said they were notified by their federal counterparts that anticipated vaccine shipments would be pared to Massachusetts and other states.

Governor Charlie Baker said he was “frustrated” by the allotment reduction. While it might delay the vaccine rollout for some for “a week or so,” he said, it was “not clear yet if it will affect the timetable in any meaningful way.” State officials said more than 6,200 front-line health workers were vaccinated this week as the Massachusetts rollout began. They hope to vaccinate 5.8 million residents by next summer.

In addition to the next shipment being trimmed by nearly 30 percent, the state’s expected allocation of the Pfizer vaccine by the end of the year will drop from 180,000 to 145,000 doses, a 20 percent cut, Massachusetts officials said.

Offsetting the reductions, though, Massachusetts expects to receive about 120,000 doses of the new Moderna vaccine, which reported a 94.1 percent effectiveness rate in a late-stage clinical trial involving 30,000 people. An advisory committee of independent medical experts endorsed the vaccine Thursday by a vote of 20-0, with one abstention.

The initial doses of the Moderna vaccine expected in Massachusetts early next week are going to hospitals, community health centers, and urgent care centers, state officials said.

But the Pfizer allotment cuts caught state officials by surprise, threatening to trip up their ambitious vaccination rollout.

“At this time it’s not clear to us why the shipment amounts have been adjusted,” Baker told reporters at a State House news briefing. “We’re certainly frustrated that we won’t be receiving the amount that we expected in the first wave, and we’re working to get clarity on what this means.”

Massachusetts is one of more than a dozen states that say they’ve been told to expect fewer doses of the Pfizer COVID-19 vaccine in its second week of distribution, prompting worries about potential delays in shots for health care workers and long-term care residents.

One logistics expert said she was taken aback by the cutback, and by the seeming effort by Pfizer and the Trump administration’s Operation Warp Speed to deflect blame.

“I can tell you, this is not how you run a supply chain,” said Nada Sanders, a professor of supply chain management at Northeastern University. “Someone is making an egregious error here.”

Sanders said she was shocked to learn of the slowdown in the vaccine supply chain, pointing out that drug manufacturers like Pfizer typically have robust operations and throughput schedules mapped out months in advance:

“Pfizer is a top-notch company and the companies they’re working with like FedEx and UPS, they have algorithms and they’re the best of the best there is. This is a ballet.”

Noting that the vaccine requires ultra-cold storage, Sanders said she fears what could be in store for Massachusetts recipients if they were not able to receive second doses of vaccines that were approved as part of a two-dose regimen, taken 21 days apart for the Pfizer vaccine.

Baker, however, told reporters that the health workers who’ve gotten their first dose already will “get their second doses on schedule, and the [schedule] is set out to make sure that we do it that way.”

Pfizer, which partnered with German biotech BioNTech to develop the first COVID-19 vaccine, issued a statement denying there are production or distribution problems. The FDA authorized the vaccine for emergency use last Friday and nationwide shipments began leaving a Pfizer plant in Kalamazoo, Mich., two days later.

“Pfizer is not having any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed,” the company said. “This week, we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. Government to the locations specified by them.

“We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses,” the company’s statement said.

Pfizer said it remains confident it can deliver up to 50 million vaccine doses globally this year and up to 1.3 billion next year.

A Command Center spokeswoman said Massachusetts officials are in touch with federal officials coordinating distribution with vaccine makers and contractors to learn when additional shipments will arrive.

On Friday, a spokeswoman for the US Department of Health and Human Services, flatly denied that Operation Warp Speed’s allocations to the states were being reduced.

A statement from the agency said there have been no changes in allocations Operation Warp Speed locked in with the states. It said states are allocated vaccine doses based on their adult populations, and the volume will depend on the amount of vaccine that’s available to be shipped.

“Operation Warp Speed remains on track to allocate enough vaccine for about 20 million Americans to receive their first doses before the end of the month,” the statement said.

Among the other states that have been told their shipments would be reduced are New Hampshire, Connecticut, California, Illinois, Michigan, Washington, Georgia, Kansas, Montana, Nebraska, Nevada, Indiana, and Rhode Island.

Baker said Friday that the Command Center and the state Department of Public Health have been working to identify inoculation sites across Massachusetts and develop a rollout program for priority groups, such as first responders, to be vaccinated after the shots for COVID-facing health care workers and long-term care facilities are administered.

“As we continue to move forward, we’ll continue to provide the latest information that we have available to the public on this process,” Baker said.

State Health and Human Services Secretary Marylou Sudders said the state is expanding its list of authorized vaccinators to include emergency medical technicians, emergency services personnel, and nursing and medical students.

“The vaccine process, much like the pandemic itself, is fast-moving and ever-changing, and we will continue to pivot as necessary,” Sudders said.

Asked if he felt anyone in the federal government “dropped the ball” on vaccine distribution, Baker didn’t answer directly.

“I view this to some extent as part of the lumpiness that comes with this, and once [the vaccination program] really starts to roll, I anticipate that we’ll probably end up receiving every bit as much as we are expecting to receive,” Baker said.

He added that glitches in the supply chain were anticipated.

“We expected and anticipated it would be a little bumpy and it is,” the governor said, “but that’s not in the grand scheme of things something I’m particularly worried about.”