For the second time this month, there’s promising news from a COVID-19 vaccine candidate: Moderna said Monday its shots provide strong protection, a dash of hope against the grim backdrop of coronavirus surges in the United States and around the world. The vaccine is among those Canada has preordered for its population.
Moderna said its vaccine appears to be 94.5 per cent effective, according to preliminary data from the company’s still-ongoing study. A week ago, competitor Pfizer Inc. announced its own COVID-19 vaccine appeared similarly effective — news that puts both companies on track to seek permission within weeks for emergency use in the United States.
Dr. Stephen Hoge, Moderna’s president, welcomed the “really important milestone,” but said having similar results from two different companies is what’s 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.
“It won’t be Moderna alone that solves this problem. It’s going to require many vaccines” to meet the global demand, he said.
A vaccine can’t come fast enough, as virus cases topped 11 million in the U.S. over the weekend — one million of them recorded in just the past week. The pandemic has killed more than 1.3 million people worldwide, more than 245,000 of them in the U.S.
Still, if the U.S. Food and Drug Administration allows emergency use of Moderna’s or Pfizer’s candidates, there will be limited, rationed supplies before the end of the year. Both require people to get two shots, several weeks apart. Moderna expects to have about 20 million doses, earmarked for the U.S., by the end of 2020. Pfizer and its German partner BioNTech expect to have about 50 million doses globally by year end.
Moderna’s vaccine, created with the National Institutes of Health, is being studied in 30,000 volunteers who received either the real vaccination or a dummy shot. It’s very unusual for results to be analyzed and released before a clinical trial is complete. Despite that, on Sunday, an independent monitoring board examined 95 infections that were recorded starting two weeks after volunteers’ second dose — and discovered all but five illnesses occurred in participants who got the placebo.
Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told NBC’s Today on Monday that Moderna’s finding, along with Pfizer’s, “is something that foretells an impact on this outbreak.”
“So now we have two vaccines that are really quite effective, so I think this is a really strong step forward to where we want to be about getting control with this outbreak,” Fauci said.
Interim analysis suggests COVID-19 vaccines from Pfizer and Moderna will work, but final results, expected later this year, are necessary to confirm, says epidemiologist Dr. Christopher Labos. 5:40
Protection rate may change
Moderna’s study is continuing, and the company acknowledged the protection rate might change as more COVID-19 infections are detected and added to the calculations. 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 vaccine’s second dose, at rates that Hoge characterized as more common than with flu shots but on par with others such as the shingles vaccine.
Moderna shares rocketed higher on the announcement and appeared to be headed for an all-time high Monday. The Cambridge, Mass., company’s vaccine is among 11 candidates in late-stage testing around the world, four of them in huge studies in the U.S.
Confidence boost
“This news from Moderna is tremendously exciting and considerably boosts optimism that we will have a choice of good vaccines in the next few months,” said Peter Openshaw, professor of experimental medicine at Imperial College London.
“This latest press release is based on a study of 30,000 U.S. adults, including many high-risk or elderly persons. This gives us confidence that the results are relevant in the people who are most at risk of COVID-19.”
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said, “We will need much more data and a full report or publication to see if the benefit is consistent across all groups, notably the elderly, but this is definitely encouraging progress.”
Both Moderna’s shots and the Pfizer-BioNTech candidate are so-called mRNA vaccines, a brand-new technology. They aren’t made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
“It’s a completely different and completely new way to make a vaccine, but it seems to work and it seems to be highly effective,” Dr. Christopher Labos, a Montreal-based epidemiologist, told CBC News Network on Monday. “It looks as if both these vaccines are going to work and very likely both these vaccines are going to be rolling out early 2021.”
The strong results were a surprise. Scientists have warned for months that any COVID-19 shot may be only as good as flu vaccines, which are about 50 per cent effective.
Another steep challenge: distributing doses that must be kept very cold. Both the Moderna and Pfizer shots are frozen but at different temperatures. Moderna announced Monday that once thawed, its doses can last longer in a refrigerator than initially thought, up to 30 days. Pfizer’s shots require long-term storage at ultra-cold temperatures, while Moderna says regular freezer temperatures will suffice for its vaccine.
