Infectious Disease

The FDA committee recommends approving the usage of the second COVID-19 vaccine within the US

17th December 2020

4 min read

Source / information

Source:
Healio interviews

Disclosure:
Kuppalli reports that he serves on an advisory committee for GlaxoSmithKline. Gandhi does not report any relevant financial information.

ADD SUBJECT TO EMAIL ALARMS

Receive an email when new articles are published

Please enter your email address to receive an email when new articles are published . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If you continue to have this problem, please contact customerservice@slackinc.com.

Back to Healio

An FDA advisory committee on Thursday approved the recommendation to approve a second emergency COVID-19 vaccine in the United States.

The Advisory Committee on Vaccines and Related Biological Products (VRBPAC) voted 20-0, with one abstention, to approve the use of the vaccine in adults aged 18 and over, paving the way for a second Emergency Use Authorization (EEA) the FDA will get a vaccine in as many weeks as is commonly expected.

COVID Vaccine Stock Image

An FDA advisory committee endorsed Moderna’s COVID-19 vaccine, opening the door for approval for emergency use.
Photo credit: Adobe Stock

The Messena RNA (mRNA) -based vaccine, developed by Moderna Inc. and the NIH, was shown to be safe and highly effective in an ongoing Phase 3 study. This comes from results that Moderna released last month and confirmed in an FDA document released this week.

Last week the VRBPAC approved another mRNA-based vaccine developed by Pfizer and BioNTech. A day later, the FDA issued an EUA for the vaccine for patients 16 years and older. Priority groups, including health care workers, received this vaccine on Monday in a record increase in cases in the United States

Monica Gandhi

Krutika Kuppalli

According to the Johns Hopkins University, more than 17 million people in the United States have been diagnosed with COVID-19 since the pandemic began and nearly 309,000 people have died.

The availability of two highly effective vaccines “will turn the tide of this pandemic once and for all,” he said Monica Gandhi MD, MPH, Professor of Medicine and Assistant Director of HIV, Infectious Diseases and Global Medicine at the University of California at San Francisco.

“The vaccines are more effective than we could have imagined a year ago, and with two options, it should be distributed and administered quickly,” Gandhi told Healio. “If it takes 70% immunity to keep viruses from spreading, I think it can be done in the US by summer 2021.”

In a VRBPAC briefing document posted online this week, the FDA confirmed that the Moderna vaccine was 94.1% effective in preventing symptomatic COVID-19, based on 196 cases in the study population as of Jan. through November 185 in the placebo group and 11 in the vaccine arm. All 30 documented cases of severe COVID-19 in the study population occurred in the placebo arm.

“It is wonderful that this vaccine is so effective and has a great safety profile.” Krutika Kuppalli, MD, Assistant professor of medicine in the Department of Infectious Diseases at the Medical University of South Carolina, said Healio. “Hopefully we can get more people to trust the vaccine and take it in.”

Gandhi found that in Moderna’s Phase 3 study, more than a third of participants from color communities participated and over 25% were over 65 years old, with the vaccine being 86.4% effective.

Unlike the Pfizer and BioNTech vaccine, which must be stored at nearly -100 ° F, the Moderna vaccine is stable for 30 days in a standard medical or household refrigerator, making it more accessible, Kuppalli said.

“This ultra-cold storage is not required, so we can make the rollout of the vaccine a little more practical for people who live in rural areas in the US and other parts of the world where this vaccine is used,” she said.

In response to claims it had manufacturing issues, Pfizer said Thursday that all of the 2.9 million doses of vaccine requested by the U.S. government had been successfully delivered to the locations where they were requested to be shipped.

“We have millions more cans in our warehouse, but so far we have not received shipping instructions for additional cans,” the company said in a statement.

Pfizer announced that it will deliver up to 50 million doses of the vaccine worldwide by the end of this year and up to 1.3 billion doses by 2021. Some sites in the US this week have noticed that Pfizer-supplied vaccine bottles contain more doses than expected. The FDA said it was okay to use every fully available dose from each vial, but that less than full doses from different vials should not be grouped together.

Moderna has announced that approximately 20 million doses of its vaccine will be ready to ship in the U.S. by the end of 2020 and up to 1 billion doses will be available worldwide by 2021. Both vaccines are given in two doses – 21 days apart from Pfizer and Moderna is 28 days apart.

“This is really a great moment for science regarding what we have done so quickly in the face of this terrible pandemic,” said Kuppalli.

Like many health care workers, Kuppalli received the first dose of the Pfizer vaccine earlier this week. Residents of long-term care facilities are also prioritized in the first wave of vaccinations.

“I had very mixed feelings about the excitement of being in the first round of vaccination, however [also] I definitely feel a bit sad and a bit guilty because there are so many people in need of this life-saving therapeutic, ”said Kuppalli. “I really want to make sure that we can make it available to everyone who needs it. I am very pleased that we are pushing this process forward to further increase our vaccine production and rollout to all who need it, not just here, but really, we need to do this around the world. ”

References:

FDA Advisory Committee on Vaccines and Related Biological Products meeting. FDA Information Document: Moderna COVID-19 Vaccine. https://www.fda.gov/media/144434/download. Accessed December 17, 2020.

ADD SUBJECT TO EMAIL ALARMS

Receive an email when new articles are published

Please enter your email address to receive an email when new articles are published . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If you continue to have this problem, please contact customerservice@slackinc.com.

Back to Healio

COVID-19 Resource Center

COVID-19 Resource Center

Related Articles