The much-needed doses are scheduled to arrive Monday after the Food and Drug Administration authorized the emergency release of the vaccine developed by Moderna Inc. and National Institutes of Health.
The movement marks the world’s first authorization for Moderna’s photographs. The vaccine is very similar to the one from Pfizer Inc. and BioNTech in Germany, which is now distributed to millions of health care workers and nursing home residents as the largest vaccination unit in U.S. history begins to grow.
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The two are working “better than we almost dared to hope,” NIH Director Dr. Francis Collins told The Associated Press. “Science works here, science has done something amazing.”
The early results of large, as yet unfinished studies show that both vaccines appear 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 is a ray of hope amid despair, as the virus continues to spread incessantly just before holiday gatherings that are sure to continue to fuel the outbreak.
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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 are on average over 216,000 a day. Deaths per day reached all-time highs, eclipsing 3,600 on Wednesday.
California has become one of the deadliest hot spots, with hospitals running out of intensive care beds and ambulances lining up outside emergency rooms in scenes reminiscent of the New York disaster last spring. California reported more than 41,000 new cases and another 300 deaths on Friday.
When hospitals in New York were in crisis, health workers across the country came to help. This time, “no cavalry is coming” because so many hospitals are flooded, said Dr. Marc Futernick, an emergency 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 aged 18 and over, Pfizer starts at the age of 16.
It’s just the beginning of “what we hope will be a big push to get this terrible virus behind us, even though it will take many months to reach all Americans,” Collins said.
Moderna expects to have between 100 and 125 million doses available globally in the first three months of 2021, with 85-100 million of those available in the US
Even with additional candidates underway, they will not be enough for the general population until spring, and photos will be rationed in the meantime. And while health workers are enthusiastically embracing vaccination, authorities are worried that the public may need more insurance to make sure more people line up when it’s their turn.
“Honestly, if we fail to get 80% of Americans immunized against COVID-19 by mid-2021, we run the risk that this epidemic may continue and continue,” Collins said.
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He is particularly concerned that accurate information about the value of the photographs reaches color communities, which have been severely affected by COVID-19, but are also cautious after years of health disparities and research abuses.
To try to build trust, Vice President Mike Pence received the Pfizer-BioNTech movie on live television on Friday with surgeon General Jerome Adams.
The FDA’s decision could help pave the way for other countries to consider the Moderna vaccine, the first regulatory clearance for small businesses in Cambridge, Massachusetts. European regulators could authorize its use as soon as 6 January. The United Kingdom, Canada and several other countries have already eliminated the Pfizer-BioNTech shooting, following a European Union decision on Monday.
“What we always want to remember is that one size fits all. We want options,” said Dr. Paul Duprex of the University of Pittsburgh.
Moderna has about 5.9 million doses ready for shipment, which is set to begin this weekend, according to Operation Warp Speed, the government’s vaccine development program. Injections of health workers and nursing home residents continue next week, before other key workers and vulnerable groups are allowed to join the line.
Both Moderna and Pfizer-BioNTech photos are the so-called mRNA vaccines, made with a revolutionary new technology. They do not contain coronavirus – which means they cannot cause infections. 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 attack if the real one appears.
Their development less than a year after the onset of coronavirus set a record for speed, but Collins stressed that this should not worry people. The speed was due to billions of investments by the company and the government, associated with years of previous scientific research, not corners.
The rigor of the analysis of these vaccines is unprecedented, Collins said. “We’re not done with that, but hope is on the way, and hope comes from this scientific trust in the brain that has completed 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. Arnold Monto of the University of Michigan, who chaired an advisory committee that publicly debated the evidence in the photos before. of those of the FDA. decisions.
The main messages of the FDA:
– Both the new Moderna vaccine and the Pfizer-BioNTech vaccine require two doses a few weeks apart. The second dose should be from the same company as the first.
– In a study of 30,000 volunteers, the Moderna vaccine was over 94% effective in preventing symptomatic COVID-19 in people 18 years of age and older. It also strongly protected older adults, who are the most vulnerable.
– Inoculations cannot throw away their masks, as it is not yet clear, nor does the vaccine prevent the silent spread of symptoms. But there was an indication that Moderna’s shot could provide some protection against asymptomatic infection.
– The Moderna study did not find major safety issues. As with Pfizer-BioNTech photography, expect arm pain, fever, fatigue, and muscle aches, which are signs that your immune system is developing.
– Both vaccines have a “remote chance” of causing a severe allergic reaction. Moderna’s study did not show any of these, although a handful were reported in the UK as Pfizer-BioNTech vaccinations began, and the FDA is considering five in the US, including a severe reaction in Alaska. The ingredients of the vaccines are not identical. However, after any COVID-19 vaccination, people should stay around 15 minutes – 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 the event of rare problems.
– Further studies are needed to determine whether the vaccine should be used by pregnant women and children. Pregnant or breast-feeding women should talk to their doctor about getting the vaccine.
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Associated Press reporter Amy Taxin contributed to the report from Orange County, California.
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