Much-needed doses are expected to come Monday after the Food and Drug Administration approved emergency vaccination by Moderna Inc. and the National Institutes of Health.
The move marks the world’s first authority for Moderna photography. The vaccine is very similar to one from Pfizer Inc. And BioNTech from Germany which is now giving it to millions of health care workers and nursing home residents as the largest vaccination campaign in U.S. history begins to ramp up.
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Both are working “almost better than we had hoped,” said NIH Director Dr. Francis Collins told The Associated Press. “Science works here, science has done something amazing.”
Early results from large, as yet incomplete studies show that both vaccines show safe and strong protection although Moderna is easier to handle as it does not require storage at ultra-freezing temperatures.
A second vaccine represents a ray of hope amid despair as the virus spreads unscathed even before holiday gatherings that are sure to put off the revolution.
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The fear has claimed more than 312,000 lives in the U.S. and killed 1.7 million people worldwide. New cases in the U.S. run at an average of more than 216,000 per day. Daily deaths have been at record highs, down 3,600 on Wednesday.
California has emerged as one of the deadliest hotspots, with hospitals running out of intensive care beds and ambulances lining the outside of emergency rooms in scenes that remind us the crash around New York City last spring. California on Friday reported more than 41,000 new cases and 300 more deaths.
When New York hospitals were in crisis, health care workers came from all over the country to help. This time, “cavalry is not coming” because so many hospitals are being immersed, said Dr. Marc Futernick, an emergency room physician in Los Angeles.
The country is scrambling to expand vaccinations as soon as Moderna and Pfizer can issue doses. Moderna’s is for people 18 and older, Pfizer starts at 16.
It is just the beginning of “what we hope will be a major effort to get this terrible virus behind us, even though it will take many more months to get to all Americans,” Collins said.
Moderna expects between 100 million and 125 million doses to be available worldwide in the first three months of 2021, with 85-100 million of those available in the US
Even with additional candidates in the pipeline, there will not be enough for the general population until the spring, and beats will be capped in the meantime. And while health workers are reluctant to accept the vaccine, authorities are concerned that the public will need more reassurance to ensure more people get in when it comes in.
“In fact if we do not succeed in getting 80% or so of Americans vaccinated against COVID-19 by the middle of this year 2021, we are at risk that this disease could go on and on. forward, “Collins said.
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It is of particular concern that accurate information about the value of sights is reaching color communities, which have been hit hard by COVID-19 but are also cautious after years of health care differences and misuse of research.
To try to boost confidence, Vice President Mike Pence received a Pfizer-BioNTech bullet on live TV on Friday, alongside Surgeon General Jerome Adams.
The FDA decision could help pave the way for other countries considering the Moderna vaccine, the first ever regulatory license for the small Cambridge, Massachusetts company. European regulators could allow it to be used as soon as Jan. 6. Britain, Canada and a few other countries have already cleared the Pfizer-BioNTech bullet, with a decision from the European Union due on Monday.
“What we always want to remember is that one size does not fit all. We want to have choices,” said Dr. Paul Duprex of the University of Pittsburgh.
Moderna has about 5.9 million doses ready to ship over the weekend, according to Operation Warp Speed, the government’s vaccine development program. Attacks by health workers and nursing home residents will continue next week, before other critical workers and vulnerable groups gain access.
Both Moderna and Pfizer-BioNTech images are so-called mRNA vaccines, manufactured with state-of-the-art technology. They do not contain coronavirus – meaning they cannot become infected. Instead, they use a piece of genetic code that trains the immune system to identify the spike protein on the surface of the virus, ready to attack if the real thing comes up.
Their development settled less than a year after the coronavirus appeared at a rapid pace, but Collins stressed that humans should not be disturbed. The pace was the result of billions in company and government investments repaired by years of previous scientific study, not any cutting corners.
“The rigor of analyzing these vaccines is unparalleled,” Collins said. “We’re not done with this but hope is on the way, and hope is coming from this scientific brain trust that has put out all the stops.”
Experts hope the two vaccines together will “break the back of pandemic” when combined with masks and other measures, said Dr. Arnold Monto of the University of Michigan, who chaired an advisory committee that publicly debated the evidence of the pictures ahead of FDA decisions.
FDA key messages:
– With the new Moderna vaccine and the Pfizer-BioNTech image two doses are required 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 inhibiting symbolic COVID-19 in people 18 and older. It is also strongly protected by older, more vulnerable adults.
– The inoculated cannot throw away their masks because it is not yet clear that a vaccine prevents the spread of a silent, symptomless virus. But there was a hint that the Moderna bullet could provide some protection from asymptomatic diseases.
– Moderna inspection found no major safety issues. Similar to the Pfizer-BioNTech picture, expect sore arms, fever, fatigue and muscle aches, which are signs that the immune system is up.
– Other vaccines have an “isolated possibility” of causing a severe allergic reaction. Moderna’s study did not turn any of these, although a handful was reported in Britain as the Pfizer-BioNTech vaccines progressed and the FDA is looking into five in the US, including bad response in Alaska. The ingredients in the vaccines are not the same. However, after any COVID-19 vaccine, people should keep around for 15 minutes – or 30 minutes if they have a history of severe allergies – so if they have a reaction, it can be treated immediately.
– Other vaccines are still being tested, and the government is closely monitoring safety in case problems are rare.
– Additional studies are needed to determine whether vaccines and pregnant children should use the vaccine. Pregnant and breastfeeding women should consider whether they should have the vaccine with their doctor.
Amy Taxin, a news reporter attached to this report from Orange County, California.
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