Loading...

Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review

December 16, 2020by Anna Edney, Bloomberg News (TNS)
Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review

Moderna Inc.’s vaccine is safe and effective for preventing COVID-19, U.S. regulators said, clearing the way for a second shot to quickly gain emergency authorization and add to the country’s sprawling immunization effort.

The Food and Drug Administration’s staff said in a report on Tuesday that the experimental vaccine is 94.1% effective at preventing symptomatic COVID-19, confirming earlier results released by the company.

The report was posted online ahead of a meeting Thursday of agency advisers who will vote whether to recommend authorization before a final FDA decision. The agency doesn’t have to follow the advice of the independent vaccine experts, though it often agrees with its advisory panels. Last week, the FDA authorized a similar vaccine from Pfizer Inc. and BioNTech SE after an advisory panel voted 17-4, with one abstention, to support its authorization.

The FDA got a much deeper look at Moderna’s clinical-trial data than the numbers previously released to the public by the company. Notably, the agency was able to review the shot’s effectiveness across a broad range of racial, ethnic and age groups, and look at evidence of how well the shot worked for people with pre-existing medical conditions that make them more vulnerable to severe COVID-19.

The agency found the shot was similarly effective across racial and ethnic groups and those with underlying medical conditions. It was 86.4% effective in people age 65 and over, according to the report, and 95.6% effective in those 18 to 65.

Both the Moderna vaccine and the Pfizer vaccine are based on messenger RNA technology that hasn’t been previously used in inoculations. Additionally, both are two-dose vaccines, meaning once people receive an initial shot they will need to return to their care providers weeks later for an additional injection.

Between Pfizer and Moderna, Operation Warp Speed officials have said 20 million people in the U.S. are expected to get their first shots by year-end.

COVID-19 cases and hospitalizations are rising across the country, increasing pressure to get the pathogen under control. While health officials are hopeful that the immunization push will begin to slow a pandemic that has killed more than 300,000 Americans, it’s not yet known what effect the vaccines have on transmission of the disease.

Pfizer and BioNTech’s vaccine was cleared first in the U.K. where there were a few reports of serious reactions that led regulators there to advise against anyone with a history of significant allergies getting the shot. The FDA did not take such a step, but told facilities where the vaccine would be administered to have medication on hand to treat possible allergic reactions, including a severe form called anaphylaxis.

Moderna’s vaccine isn’t yet approved in any other countries and hasn’t yet been used on anyone outside of a clinical trial.

Once the U.S. grants authorization, advisers to the Centers for Disease Control and Prevention must meet, as they did last week on Pfizer’s vaccine, to give Moderna’s shot the green light and provide offer specific recommendations for use and monitoring. Moderna’s vaccine will be distributed to sites around the country where health-care workers and residents of long-term care facilities, such as nursing homes, are expected to get the earliest doses.

Pfizer and BioNTech’s first vaccines were sent to more than 600 sites around the country. The shot must be kept extremely cold and requires special freezers to transport, while Moderna’s can be kept in more traditional cold storage.

___

©2020 Bloomberg L.P.

Distributed by Tribune Content Agency, LLC

In The News

Health

Voting

Health

A Key Inflation Gauge Rose 5.8% in 2021, Most in 39 Years

WASHINGTON (AP) — A measure of prices that is closely tracked by the Federal Reserve rose 5.8% last year, the... Read More

WASHINGTON (AP) — A measure of prices that is closely tracked by the Federal Reserve rose 5.8% last year, the sharpest increase since 1982, as brisk consumer spending collided with snarled supply chains to raise the costs of food, furniture, appliances and other goods. The report... Read More

January 27, 2022
by Alexa Hornbeck
Federal Efforts Aim to Combat ‘Silent Pandemic’ of Antimicrobial Resistance  

WASHINGTON — A recent study published in the Lancet is the first to provide estimates that the global death toll... Read More

WASHINGTON — A recent study published in the Lancet is the first to provide estimates that the global death toll from antimicrobial resistance is greater than that of HIV or malaria. “It was our role to provide the most comprehensive results available for these [global health]... Read More

January 26, 2022
by Alexa Hornbeck
EPA and WHO Sign Memorandum With New Actions to Protect Human Health

The U.S. Environmental Protection Agency and World Health Organization recently signed a five-year Memorandum of Understanding with new actions for protecting human health... Read More

The U.S. Environmental Protection Agency and World Health Organization recently signed a five-year Memorandum of Understanding with new actions for protecting human health and the environment. “The COVID-19 pandemic has highlighted the intimate links between humans and our environment,” said Dr. Tedros Adhanom Ghebreyesus, WHO director-general, in a written statement. ... Read More

January 26, 2022
by Alexa Hornbeck
Black Patients With Dementia More Likely to Receive Aggressive Care in Nursing Homes 

A recent study published in JAMA Internal Medicine shows that Black nursing home residents with advanced dementia likely receive more aggressive care... Read More

A recent study published in JAMA Internal Medicine shows that Black nursing home residents with advanced dementia likely receive more aggressive care than non-Black residents.  A team of researchers from Massachusetts, Tennessee, Georgia and North Carolina conducted the qualitative study with 169 staff interviews in 14 nursing homes... Read More

January 26, 2022
by Alexa Hornbeck
UCSD Offers Magnetic Stimulation for Patients With Treatment-Resistant Depression 

The University of California San Diego Health now offers a new treatment for patients with treatment-resistant depression, called transcranial magnetic stimulation.... Read More

The University of California San Diego Health now offers a new treatment for patients with treatment-resistant depression, called transcranial magnetic stimulation. TMS is a treatment approved by the U.S. Food and Drug Administration to stimulate nerve cells in areas of the brain associated with major depression. The... Read More

January 26, 2022
by Alexa Hornbeck
Rhode Island Delays Enforcement of Law to Increase Staffing in Nursing Homes 

In Rhode Island, Gov. Dan McKee recently signed an executive order to halt the enforcement of the Nursing Home Staffing and Quality Care... Read More

In Rhode Island, Gov. Dan McKee recently signed an executive order to halt the enforcement of the Nursing Home Staffing and Quality Care Act, which he signed into law last May to give nursing homes across the state a higher staff-to-patient ratio.  The Nursing Home Staffing and Quality Care... Read More

News From The Well
Exit mobile version