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Full FDA approval can lead to vaccinations, but experts advise not to wait

Modern files for full FDA approval of the COVID-19 vaccine



One-third of unvaccinated seniors in the United States say they will enter the queue for the COVID-19 only after it is fully approved, but medical experts say it may be risky to wait.

Moderna became the last manufacturer of COVID-19 vaccines to apply for full approval from the Food and Drug Administration, announcing last week that it had begun the approval process for people over the age of 18. This follows Pfizer’s announcement in early May that it is seeking approval for those 16 years or more.

About half of the country has so far received at least one dose of the COVID-19 vaccine, which was provided in the United States through an emergency use permit because of the public emergency that the pandemic poses. As vaccination rates decrease, full FDA approval can give them a boost, as the distinction is important for a large proportion of people who remain unvaccinated. According to the latest Kaiser Family Foundation vaccine monitoring report, nearly a third – 32% – of unvaccinated adults wait for full FDA approval for a vaccine before receiving it.

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Dr William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said the large share of those waiting for approval was a surprise.

“I think that probably means more to the general public than it really should,” Moss told ABC News. “To think that this approval process will be ‘all-all’ and ‘all-end’ is wrong for me.”

Both authorization and approval are rigorous processes that address the safety and efficacy of the vaccine, Moss said. A key difference between the two is that at least two months of follow-up data from phase 3 clinical trials are considered for authorization, as opposed to at least six months for approval.

man in a blue shirt: RN Natalie O'Connor loads syringes with the Moderna COVID-19 vaccine before heading to patients in Bloomfield, Ct., February 12, 2021.

© Joseph Prezioso / AFP via Getty Images, FILE
RN Natalie O’Connor loaded syringes with the Moderna COVID-19 vaccine before heading to patients in Bloomfield, Ct., February 12, 2021.

It will take the FDA several months to review the full set of data before giving approval, which several experts said ABC News is very likely. For Moss, with nearly 300 million doses administered in the United States, “there is nothing in this review process that reveals everything we don’t know.”

Video: Moderna wants full FDA approval for its COVID-19 vaccine (Yahoo! Finance)

“Yes, it’s kind of an official seal of approval, but I don’t think it really provides much more than we already know,” he said. “We have more data on the safety of vaccines than with any other vaccine, even before the full approval review.”

Both Pfizer and Moderna said their vaccines continued to offer strong protection six months after the second dose, including against emerging variants, and did not report any serious safety concerns. The vaccine adverse event reporting system also provides transparency and helps identify the very rare chance of blood clotting, some of which have been diagnosed after receiving the Johnson & Johnson vaccine.

Full approval will allow the vaccines to be used after the end of public health emergencies in the United States. It will also allow companies to advertise their vaccines to people, which could help promote vaccination, Dr. James McDevitt, senior vice president and dean of clinical affairs at Baylor Medical College, told ABC News.

“I think there is a significant benefit if we start having private, professionally produced ads that will encourage people to get vaccinated,” he said. It can be an important engine.

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At the same time, McDeavitt would also encourage people not to wait for approval if they plan to receive the vaccine.

“If you wait a month or two or three, you run the risk of being unnecessary and preventable,” he said. “[The COVID-19 vaccine is] it’s free, it’s incredibly safe, and it’s easily accessible. In my personal opinion, there is no point in waiting. ”

Dr John Braunstein, an epidemiologist at Boston Children’s Hospital and a contributor to ABC News, said that if waiting for approval vaccinated more people, it was positive, but he also said there were risks in waiting as COVID transmission -19 remains active.

“All signs point to full approval,” he said. “So this may take into account the decision on expected approval in relation to the potential risk of non-vaccination.”

In addition to approval, paid free time was another barrier for people who have not yet been vaccinated. A study by the Kaiser Family Foundation found that 21% of employed, unvaccinated adults would be more likely to receive the vaccine if their employer gave them paid leave to receive it and recover from side effects.

In addition, between 10% and 15% of unvaccinated adults say they are more likely to receive the vaccine if there is a financial incentive, such as money or free tickets, the study found.

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Seven percent say they will be vaccinated “only if necessary.” Full FDA approval could open the door to more companies and schools that oblige it, further increasing vaccine intake, Braunstein said.

“I think we will see more mandates for vaccines being opened by employers or other institutions, maybe even government institutions,” Moss said. “I think they will feel more comfortable requiring their employees to be vaccinated, obviously with certain exemption rules, after full approval.”

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