The United States added a second Covid-19 vaccine to its arsenal on Friday, fueling efforts to combat an outbreak so dire that the nation regularly records more than 3,000 deaths per day.
The much-needed doses are scheduled to arrive Monday after the Food and Drug Administration authorized an emergency launch of the vaccine developed by Moderna Inc. and the National Institutes of Health.
The move marks the world’s first clearance for Moderna shots. The vaccine is very similar to one from Germany’s Pfizer Inc. and BioNTech that is now distributed to millions of healthcare workers and nursing home residents as the largest vaccination campaign in US history begins to ramp up. USA
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Both work “better than we almost dared hope,” NIH Director Dr. Francis Collins told The Associated Press. “Science is working here, science has done something amazing.”
The first results of large studies, still unfinished, show that both vaccines appear safe and very protective, although Moderna is easier to handle since it does not need to be stored at deep-frozen temperatures.
A second vaccine represents a ray of hope amid despair as the virus continues to spread unabated even before the holiday gatherings that are sure to further fuel the outbreak.
The scourge has claimed more than 312,000 lives in the United States and killed 1.7 million people worldwide. New cases in the US exceed 216,000 per day on average. Deaths per day have reached record highs, dwarfing 3,600 on Wednesday.
California has become 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 calamity in New York City last spring. California reported more than 41,000 new cases and 300 more deaths on Friday.
When New York hospitals were in crisis, healthcare workers from across the country came to help. This time around, “the cavalry is not coming” because many hospitals are crowded, said Dr. Marc Futernick, a Los Angeles emergency room physician.
The nation is struggling to expand vaccines as fast as Moderna and Pfizer can produce doses. Moderna’s is for people over 18, Pfizer’s starts at 16.
It is just the beginning of “what we hope will be a huge push to put this terrible virus behind us, although it will take many more months to reach all Americans,” Collins said.
Even with additional candidates in the pipeline, there won’t be enough for the general population until spring, and vaccines will be rationed in the meantime. And while healthcare workers are enthusiastically embracing vaccination, authorities fear the public may need more reassurance to make sure more people line up when it’s their turn.
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“Frankly, if we fail to immunize 80% of Americans against Covid-19 by the middle of this year 2021, we run the risk of this epidemic going on and on,” Collins said.
He is especially concerned that accurate information about the value of injections is reaching communities of color, which have been hard hit by Covid-19 but are also wary after years of healthcare disparities and research abuses.
To try to help instill confidence, Vice President Mike Pence hosted the Pfizer-BioNTech takeover on live television on Friday, along with Surgeon General Jerome Adams.
The FDA’s decision could help pave the way for other countries considering the Moderna vaccine, the first regulatory clearance for the Cambridge, Massachusetts small business. European regulators could authorize its use as early as January 6. Britain, Canada and a few other countries have already approved the Pfizer-BioNTech vaccine, and the European Union is due to make a decision on Monday.
“What we always want to remember is that one size does not fit all. We want to have options, ”said Dr. Paul Duprex of the University of Pittsburgh.
Moderna has about 5.9 million doses ready for shipment starting over the weekend, according to Operation Warp Speed, the government’s vaccine development program. Injections to healthcare workers and nursing home residents continue next week, before other essential workers and vulnerable groups are allowed to line up.
Both Moderna and Pfizer-BioNTech injections are so-called mRNA vaccines, made with a revolutionary new technology. They do not contain any coronaviruses, 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 surface of the virus, ready to strike if something real appears.
Its development less than a year after the onset of the coronavirus set a speed record, but Collins stressed that it shouldn’t worry people. The speed was due to billions in investment from businesses and governments along with years of prior scientific research, not cuts.
“The rigor of testing these vaccines is unprecedented,” Collins said. “We are not done with this, but hope is on the way, and hope comes from this confidence from the scientific brain that has done its best.”
Experts hope the two vaccines together “break the back of the pandemic” when combined with masks and other precautions, said Dr. Arnold Monto of the University of Michigan, who chaired an advisory committee that publicly debated the evidence of the injections before the FDA. 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 over 18 years of age. It also strongly protected the elderly, who are the most vulnerable.
The inoculated cannot throw off their masks, as it is not yet clear whether any of the vaccines prevent the silent and symptom-free spread of the virus. But there was a hint that the Moderna injection might provide some protection against an asymptomatic infection.
Moderna’s study found no major security issues. As with the Pfizer-BioNTech injection, expect arm pain, fever, fatigue, and muscle aches, which are signs that the immune system is picking up.
Moderna’s study found no serious allergic reactions, like the few reported with Pfizer-BioNTech injections in Britain and Alaska. The ingredients of the vaccines are not identical. Still, after any Covid-19 vaccination, people should stay for 15 minutes, or 30 minutes if they have a history of severe allergies, so if they do have a reaction, it can be treated immediately.
Both vaccines remain experimental and the government is closely monitoring safety in case rare problems arise.
– Additional studies are needed to know if the vaccine should be used by children and pregnant women.
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