Saturday, October 16

Recommendation Paves The Way For FDA Clearance Of Modern Covid Vaccine In US Coronavirus

An advisory committee of the United States Food and Drug Administration (FDA) recommended that the agency authorize a second Covid-19 vaccine, this one developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID).

The recommendation paves the way for the FDA to grant emergency approval for a second highly effective vaccine to be used in the US That approval could come by the end of the week. An FDA analysis found Moderna’s vaccine to be more than 94% effective in preventing Covid-19 in a trial of more than 30,000 participants.

The likely authorization of the second vaccine comes after more than 300,000 Americans have succumbed to Covid-19, in a winter “third wave” of the disease that is filling hospitals with patients and depleting healthcare workers.

The recommendation comes from the vaccine advisory committee at the FDA’s Center for Research and Evaluation and Biological Research, an independent panel of experts that last week recommended that the agency authorize a vaccine developed by Pfizer / BioNTech.

“The question is never when you know everything, but when you know enough,” said Dr. Paul Offit, an expert in vaccines and infectious diseases at Children’s Hospital of Philadelphia. The answer to whether the advisory committee should recommend emergency authorization of the vaccine is “Clearly yes.”

“We are talking about a pandemic where we really need to move forward,” said Dr. Steven Pergam, another board member and infectious disease expert for the Seattle Cancer Care Alliance.

The Pfizer vaccine became the first drug authorized by the FDA to prevent Covid-19 in the US It was previously licensed by the UK and Canada. While the FDA does not always follow the advice of its expert committees, the agency is expected to quickly authorize the Moderna vaccine for emergency use.

Like Pfizer’s vaccine, Moderna’s drug to prevent Covid-19 uses messenger RNA technology. This technology introduces the body to the spike protein that coats the surface of the coronavirus.

The vaccine was developed in a joint effort by Moderna Inc and NIAID. It received nearly $ 2.5 billion in funding from the US government, and the federal government has already purchased 200 million doses with the option to buy 300 million more.

Emergency approval of a second vaccine would put the US on track to potentially immunize up to 150 million people between now and mid-2021, if the government can effectively implement the most challenging public health campaign from the point logistical view of history.

Both vaccines require two-dose “booster” regimens. Approximately 6 million doses are expected to begin shipping immediately after FDA emergency clearance. The federal government will pay for both vaccines, with no out-of-pocket costs for Americans.

In particular, the audience for the second possible vaccine included doctors who spoke about the impact Covid-19 has had on themselves and their staff.

“There is a real price to pay for acquiring Covid,” said Dr. Douglas Dieterich, a professor of medicine at the Mount Sinai liver disease institute who became infected with Covid-19 and lost his sense of smell and sensation in his feet. . , among other long-term side effects. “I think the vaccine is the answer to prevent Covid-19,” he said.

Dr. Donald Middleton, a physician at the University of Pittsburgh Medical Center, said one of his residents was about to sedate an intubated 70-year-old Covid-19 patient when she wrote him a note. “I love you all, my life is in your hands,” wrote the patient.

“Although your staff do their duty on a daily basis, they are in hell,” Middletown said. “Please advise the FDA to give this excellent [emergency authorization] state.”

The second US clearance comes as the FDA is updating the guidelines given to physicians after a healthcare worker in Alaska experienced an allergic reaction immediately after receiving the vaccine. The Moderna scientists said there were two allergic reactions in their trial, one in the placebo group and one in a vaccine recipient.

In the vaccine arm, the allergic reaction occurred more than 60 days after the participant received the vaccine and was found to be related to a separate medical procedure.

The second approval also poses a substantial challenge for vaccine researchers, who are now “experiencing significant drop-out” in the blind, placebo-controlled trial as vaccines become available, said Dr. Lindsey R Baden, one of the three. co-principal investigators and physician at Brigham and Women’s Hospital in Massachusetts. That means that observational data, considered to be of lower quality, will need to be carefully analyzed to gain more information about the vaccine as it is distributed.

Even with this second approval, the US would still need to authorize more vaccines to vaccinate most Americans. Moderna’s vaccine, like Pfizer’s, would be licensed for emergency use with the idea that the company would seek full approval in the coming months.

Importantly, Moderna’s vaccine has two distinct advantages over Pfizer’s. First, it doesn’t require ultra-cold storage. That means the vaccine could be less susceptible to waste and easier to transport to rural communities. It also does not require dilution or mixing, like the Pfizer vaccine.

The second advantage is more subtle: data from Moderna’s Phase III clinical trial showed that no member of the vaccinated group developed severe Covid-19, where 30 members of the placebo group did. This means that for the 6% of people who do not receive the preventive effects of the vaccine, the vaccine can still reduce the severity of symptoms.

The Pfizer vaccine is licensed in children up to 16 years of age, but Moderna’s vaccine can only be used in adults over 18 years of age. That could leave about a quarter of the population vulnerable to coronavirus infection and increase the need to universally vaccinate adults.

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