A second experimental COVID-19 vaccine — this one from Massachusetts-based Moderna — yielded extraordinarily strong early results Monday, another badly needed dose of hope as the coronavirus pandemic enters a terrible new phase.
Moderna, based in Cambridge, said its vaccine appears to be 94.5 percent effective, according to preliminary data from an ongoing study. A week ago, competitor Pfizer announced that its vaccine looked 90 percent effective — news that puts both companies on track to seek permission within weeks for emergency use in the U.S.
How that all might play out in the Berkshires remains a question mark.
The results are “truly striking,” said Dr. Anthony Fauci, the U.S. government’s top infectious-diseases expert. “The vaccines that we’re talking about, and vaccines to come, are really the light at the end of the tunnel.”
A vaccine can’t come fast enough, as virus cases topped 11 million in the U.S. over the weekend — 1 million of them were recorded in just the past week — and governors and mayors are ratcheting up restrictions ahead of Thanksgiving. The outbreak has killed more than 1.3 million people worldwide, over 246,000 of them in the U.S.
Both vaccines require two shots, given several weeks apart. U.S. officials said they hope to have about 20 million Moderna doses and an additional 20 million of the vaccine made by Pfizer and its German partner, BioNTech, to use in late December.
Dr. Stephen Hoge, Moderna’s president, welcomed the “really important milestone” but said that having similar results from two companies is what is most reassuring.
“That should give us all hope that actually a vaccine is going to be able to stop this pandemic and, hopefully, get us back to our lives,” Hoge told The Associated Press. He added: “It won’t be Moderna alone that solves this problem. It’s going to require many vaccines” to meet the global demand.
If the Food and Drug Administration allows emergency use of Moderna’s or Pfizer’s candidate, there will be limited, rationed supplies before the end of the year.
Last month, the Massachusetts Department of Public Health released an interim draft plan for distributing a COVID-19 vaccination, but local health officials said Monday they still await details from the DPH about how distribution would work in the Berkshires.
“We haven’t been in conversations with the Mass. DPH about that yet,” said Pittsfield Director of Public Health Gina Armstrong. “We’re hoping that we’ll learn more about the plans that they have developed in the near future.”
Boards of health across the state have their own plans for administering medications and vaccinations during an emergency, Armstrong said. But, plans for administering a COVID-19 vaccine to the community would pose challenges logistically, she said, because Pfizer’s vaccine must be stored at temperatures of around minus 94 degrees Fahrenheit.
Moderna’s vaccine also starts off frozen, but the company said Monday it can be thawed and kept in a regular refrigerator for 30 days, easing that concern.
Berkshire Medical Center, like other hospital systems, does not currently have the equipment required to store Pfizer’s vaccine, according to a hospital spokesman. Michael Leary said he would anticipate that state and federal authorities would ensure BMC and medical facilities in the same boat are able to meet the requirements for vaccine distribution.
“We don’t have anything that can store at that temperature,” Leary said. “I don’t know too many hospitals that do.”
Recently, BMC conducted a tabletop drill — a simulation that participants joined via Zoom — to work through and plan for issues that could arise during vaccine distribution, Leary said.
While details are forthcoming, he said that frontline health care workers and first responders would be prioritized for a vaccine.
Exactly who is first in line has yet to be decided. But, U.S. Health and Human Services Secretary Alex Azar said the hope is that enough doses are available by the end of January to vaccinate adults older than 65 — they are at the highest risk from the coronavirus — and health care workers. Fauci said it might take until spring or summer before anyone who is not high risk and wants a shot can get one.
Neal Browning, of Bothell, Wash., who rolled up his sleeve in March for the first testing of Moderna’s vaccine in humans, said he is excited about Monday’s “excellent news” but still is carefully wearing a mask and taking other precautions.
“I’m super happy to be a part of this and to try and help bring some kind of peace back to the world,” Browning said. “I have a lot of hope.”
The National Institutes of Health helped create the vaccine Moderna is manufacturing, and its director, Dr. Francis Collins, said the two companies’ parallel results give scientists “a lot of confidence that we’re on the path towards having effective vaccines.”
But, “we’re also at this really dark time,” he warned, saying people can’t let down their guard during the months it will take for doses of any vaccines cleared by the FDA to start reaching a large share of the population.
Moderna’s vaccine is being studied in 30,000 volunteers who received either the real thing or a dummy shot. On Sunday, an independent monitoring board examined 95 infections that were recorded after volunteers’ second shot. Only five of the illnesses were in people given the vaccine.
Earlier this year, Fauci said he would be happy with a COVID-19 vaccine that was 60 percent effective.
The study is continuing, and Moderna acknowledged that the protection rate might change as more COVID-19 infections are detected. Also, it’s too soon to know how long protection lasts. Both cautions apply to Pfizer’s vaccine as well.
But, Moderna’s independent monitors reported some additional, promising tidbits: All 11 severe COVID-19 cases were among placebo recipients, and there were no significant safety concerns. The main side effects were fatigue, muscle aches and injection-site pain after the second dose.
Scientists not involved with the testing were encouraged but cautioned that the FDA still must scrutinize the safety data and decide whether to allow vaccinations outside a research study.
“We’re not to the finish line yet,” said Dr. James Cutrell, an infectious-disease expert at UT Southwestern Medical Center in Dallas. “If there’s an impression or perception that there’s just a rubber stamp, or due diligence wasn’t done to look at the data, that could weaken public confidence.”
Beyond the U.S., other governments and the World Health Organization, which aims to buy doses for poor countries, will have to separately decide if and when vaccines should be rolled out broadly.
“There are many, many questions still remaining,” including how long protection lasts and if the first vaccines to emerge work as well in older people as in the young, said WHO chief scientist Dr. Soumya Swaminathan. “We also hope the clinical trials will continue to collect data, because it’s really going to be important for us to know in the long term.”
Eagle reporter Amanda Burke contributed to this report.