FDA review says Moderna COVID-19 vaccine is safe, effective
Jan 16 2021
All 50 states, Washington, DC and Puerto Rico have now received their first shipments of the Pfizer vaccine, according to statements from the state departments of health, governor's offices and local hospitals.
For health care workers, who along with nursing home residents will be first in line for vaccination, hope is tempered by grief and the sheer exhaustion of months spent battling a coronavirus that still is surging in the United States and around the world.
Sandra Lindsay (L), a nurse at Long Island Jewish Medical Center, is inoculated with the Covid-19 vaccine by Dr. Michelle Chester, at Long Island Jewish Medical Center, on December 14, 2020 in the Queens borough of NY.
The Food and Drug Administration said in documents posted online Tuesday that its initial review confirmed the efficacy and safety of the vaccine developed by Moderna and the National Institutes of Health, bringing the shot to the cusp of US authorization. Miami was one of 89 cities around the US that's tested the Moderna COVID-19 vaccine, which is expected to be available in Canada shortly.
"I'm feeling well", said Lindsay. Each vaccination requires two doses. It is a constant flow of available vaccine.
The Pfizer and Moderna vaccines are expected to be distributed on a large scale by next spring.
During the first wave of the pandemic, the virus killed almost 6,000 residents in nursing and retirement facilities, accounting for more than 80 per cent of Canada's COVID-19 deaths.
Perna and other US officials reiterated their projection that 20 million Americans will be able to get their first shots by the end of December, and 30 million more in January.
His announcement followed comments by Health Canada's chief medical adviser on Monday that the country was on track to approve Moderna's vaccine soon-though Dr. Supriya Sharma provided no hard date.
In scrutinising early results of a 30,000-person study, the FDA found it also worked just about the same.
Prime Minister Justin Trudeau said today that the Moderna COVID-19 vaccine will be available in Canada by the end of the month-if it passes regulatory muster. The main side effects were fatigue, muscle aches and injection-site pain after the second dose. Pfizer plans to apply for full FDA approval in April 2021 when it has collected six months of safety data, per the New York Times.
About 1.5% of vaccine recipients and 1.1% who got dummy shots reported possible smaller "hypersensitivity" reactions.
Both the countries have started administering the coronavirus vaccine shots to healthcare workers and elderly citizens.
They are not made with coronavirus itself, meaning there is no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.