The much-needed doses will arrive Monday after the Food and Drug Administration clears an emergency rollout of the vaccine developed by Moderna Inc. and the National Institutes of Health.
The move marks the world’s first authorization for Moderna’s shooting. The vaccine is very similar to that of Pfizer Inc. and Germany’s BioNTech, which is now being provided to millions of health workers and nursing home residents, as the largest vaccination drive in US history begins to increase.
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The two work “better than we could have hoped,” NIH director Dr. Francis Collins to The Associated Press. “Science works here, science has done a great thing.”
Initial results from large, pending studies show that both vaccines appear to be safe and highly protective, although Moderna is easier to handle because it does not need to be stored at ultra-frozen temperatures.
A second vaccine represents a ray of hope in the midst of despair as the virus continues to spread unabated even ahead of holiday gatherings that are sure to fuel the outbreak further.
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The plague has claimed more than 312,000 American lives and killed 1.7 million people worldwide. The number of new cases in the US averages over 216,000 per day. The number of deaths per day has hit record highs, surpassing 3,600 on Wednesday.
California has emerged as one of the deadliest hot spots, with hospitals running out of intensive care beds and ambulances queuing outside emergency rooms in scenes reminiscent of the New York City disaster last spring. California reported more than 41,000 new cases and 300 more deaths on Friday.
When hospitals in New York were in crisis, health workers from all over the country came to help. This time “there will be no cavalry” because so many hospitals have been flooded, said Dr. Marc Futernick, emergency room physician in Los Angeles.
The nation is struggling to expand vaccinations as quickly as Moderna and Pfizer can produce doses. Moderna’s is for people 18 and older, Pfizer starts at the age of 16.
It’s just the beginning of “what we hope will be a big push to get this horrible virus behind us, although it will take many months to reach all Americans,” Collins said.
Moderna expects to have between 100 million and 125 million doses available worldwide in the first three months of 2021, of which 85-100 million in the US.
Even with additional candidates in the pipeline, there won’t be enough for the general population until spring and the shots will be rationed in the meantime. And while health workers are enthusiastically embracing vaccination, authorities are concerned that the public will need more reassurance to get more people to queue when it comes their turn.
“If we fail to get about 80% of Americans immunized against COVID-19 by mid-2021, we run the risk that this epidemic could go on,” Collins said.
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He is particularly concerned that accurate information about the value of the shots is reaching color communities, which have been badly affected by COVID-19, but are also wary after years of disparities in health care and research misuse.
To try to instill confidence, Vice President Mike Pence received the Pfizer-BioNTech recording live on TV on Friday, along with Surgeon General Jerome Adams.
The FDA’s decision could pave the way for other countries considering the Moderna vaccine, the first-ever regulatory approval for the small company in Cambridge, Massachusetts. European regulators could approve its use as early as January 6. Britain, Canada and a few other countries have already approved the Pfizer-BioNTech shot, with a European Union decision due on Monday.
“What we always want to remember is that one size doesn’t fit everyone. We want to have options,” said Dr. Paul Duprex of the University of Pittsburgh.
According to Operation Warp Speed, the government’s vaccine development program, Moderna has approximately 5.9 million doses ready for shipment. Injections of health workers and nursing home residents will continue next week, before other vital workers and vulnerable groups are allowed to queue.
The shots from both Moderna and Pfizer-BioNTech are so-called mRNA vaccines, made with groundbreaking new technology. They do not contain coronavirus, which means that they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the virus’s surface, ready to attack when the real thing comes along.
Their development less than a year after the coronavirus first emerged set a speed record, but Collins stressed that people shouldn’t worry about that. The speed was due to billions in corporate and government investment combined with years of previous scientific research, not budget cuts.
“The accuracy of the analysis of these vaccines is unprecedented,” said Collins. “We’re not done with this yet, but hope is underway, and hope comes from this scientific brain confidence that has pulled out all the stops.”
Experts hope the two vaccines together will “break the back of the pandemic” when combined with masks and other precautions, said Dr. decisions.
The main messages from the FDA:
–Both the new Moderna vaccine and the Pfizer-BioNTech injection require two doses several weeks apart. The second dose must be from the same company as the first.
– In a study of 30,000 volunteers, the Moderna vaccine was more than 94% effective in preventing symptomatic COVID-19 in people 18 years and older. It also greatly protected the older adults, who are the most vulnerable.
– The vaccines cannot throw away their masks, because it is not yet clear that both vaccines prevent the silent, symptom-free spread of the virus. But there was a hint that Moderna injection would provide some protection against asymptomatic infection.
– The Moderna study did not reveal any major safety concerns. As with the Pfizer-BioNTech injection, you can expect sore arms, fever, fatigue, and muscle pain, which are signs that the immune system is on the rise.
– Both vaccines have “a small chance” of causing a serious allergic reaction. Moderna’s study yielded none of these, although a handful were reported in Britain when the Pfizer-BioNTech vaccinations started and the FDA is investigating five in the US, including a serious reaction in Alaska. The ingredients of the vaccines are not identical. Still, people need to linger for 15 minutes after each vaccination with COVID-19 – or 30 minutes if they have a history of severe allergies – so if they have a reaction, it can be treated immediately.
– Both vaccines remain experimental and the government is closely monitoring safety in case rare issues arise.
– Additional studies are needed to determine whether the vaccine can be used by pregnant women and children. Women who are pregnant or breastfeeding should discuss with their doctor whether they can receive the vaccine.
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Amy Taxin, Associated Press reporter, contributed to this report from Orange County, California.
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