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Friday, January 22, 2021

US Gives Favorable Review to Second COVID-19 Vaccine

As U.S. hospitals ramped up COVID-19 vaccinations Tuesday with the first vaccine approved for emergency use, federal regulators issued a favorable review of a second vaccine needed to combat the country’s worsening crisis.

The Food and Drug Administration said its preliminary analysis of a vaccine developed by Moderna and the National Institutes of Health confirmed its safety and effectiveness.

The FDA’s review moves the Moderna vaccine closer to regulatory authorization and comes as U.S. hospitals increased vaccinations with the shot developed by Pfizer and BioNTech, which the FDA cleared for emergency use last week.

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A committee of outside expert advisers will offer their recommendation on the Moderna vaccine on Thursday, with a final FDA decision expected shortly thereafter.

FDA staff members did not raise any significant new concerns about the Moderna vaccine in documents, released Tuesday, that were prepared for Thursday’s meeting of experts.

The U.S. began administering the Pfizer vaccine on Monday, with health care workers among the first to get shots.

Critical care nurse Sandra Lindsay was the first to receive an injection in New York state, a moment heralded by outgoing President Donald Trump, who had for months pushed for rapid development of a vaccine even after downplaying the severity of the health crisis early on.

“First Vaccine Administered. Congratulations USA! Congratulations World!” Trump said on Twitter.

Super-cooled shipments of the vaccine rolled out of a Pfizer manufacturing facility in Kalamazoo, Michigan, on Sunday for rapid air freight distribution to regional hubs across the United States. Pfizer developed the vaccine alongside German partner BioNTech.

The temperature on a freezer reads -69°C as workers move boxes containing the Pfizer-BioNTech COVID-19 vaccines to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant in Portage, Michigan.

In Washington, Dr. Raymond Pla, an anesthesiologist at George Washington University Hospital, was visibly emotional when he spoke to reporters after he and four of his colleagues received the vaccine.

“Excitement, in my personal view, doesn’t give the appropriate amount of deference and respect and honor to the sacrifice of my colleagues in health care, some of whom have gotten sick, some of whom have died,” Pla said.

Army Gen. Gustave Perna, chief officer of Operation Warp Speed, the Trump administration’s vaccine development program, said the vaccine distribution went incredibly well.

The coronavirus which causes the COVID-19 disease has killed more than 300,000 Americans and infected more than 16.5 million, more than in any other country, according to the Johns Hopkins University.

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Health care workers and elderly people in long-term care facilities are the first to receive the first round of 2.9 million doses at a time when cases are surging in the U.S. by tens of thousands a day.

Food and Drug Administration Commissioner Steven Hahn said it is possible that 20 million Americans will be able to get vaccinated with the first of two required doses by the end of December.

Moncef Slaoui, chief adviser to the government’s vaccine development, told the U.S. cable news program “Fox News Sunday” that 100 million Americans might be vaccinated by the end of March.

But on the ABC News show “This Week,” Hahn said it was a “significant problem” that a quarter to half of Americans, according to polls, are wary of the vaccine produced by Pfizer and BioNTech, despite being approved by U.S. health regulators. Others have vowed to not be inoculated.

Hahn said the government has “to be transparent on the safety” of the Pfizer vaccine, as well as on the Moderna vaccine being reviewed by regulators this week. Clinical tests showed both were 95% effective. 

Slaoui said that for the United States to acquire “herd immunity,” which would halt transmission of the deadly virus, the country needs about 75% or 80% of the population immunized. Slaoui said he hopes that point could be reached between May and June.

“It is, however, critical that most of the American people decide and accept to take the vaccine,” Slaoui said. “We are very concerned by the hesitancy that we see.”

Dr. Pla, an African-American, said he felt a personal responsibility to take the vaccine, given the high degree of reluctance within the Black community due to decades of racist practices that have both led to a lack of basic, decent care and being subjected to unethical medical research. He said “going out into the community and spreading the word” would be vital in easing fears among African-Americans and building up trust in that community.

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