As of early December 2020, five pharmaceutical companies are running large-scale Phase 3 clinical trials testing the efficacy and safety of experimental COVID-19 vaccines.
These five companies include AstraZeneca, Janssen, Moderna, Novavax, and Pfizer. Every few weeks, new updates and discoveries are released as these pharmaceutical giants inch closer to FDA approval.
Some vaccines have even been approved in other countries while still pending review and approval in the U.S. Here are the most significant discoveries and updates on COVID-19 vaccines as 2020 comes to a close.
Pfizer/BioNTech Vaccine Approved in the UK
In Great Britain, the medical regulating body MHRA recently declared that Pfizer’s experimental COVID-19 vaccine offers up to 90% protection against the illness. As a result, the MHRA has officially declared Pfizer’s vaccine safe to be rolled out to elderly people in care homes and care home staff in the UK.
It took only 10 months for Pfizer to go from concept to reality, a process that normally spans about 10 years. While the UK has ordered 40 million doses, or enough to vaccinate 20 million people, Prime Minister Boris Johnson reminded the public not to get “carried away with over optimism or falling into the naive belief that our struggle is over.”
According to information released by Pfizer in mid-November, the vaccine known as BNT162b2 becomes effective against COVID-19 about 28 days after the first dose. Out of 170 confirmed cases of COVID-19 evaluated, only 8 occurred in the vaccine group, and the other 162 occurred in the placebo group. Even better, efficacy was consistent across age, gender, race, and ethnicity demographics.
All of this means that the safety data milestone required by the U.S Food and Drug Administration for Emergency Use Authorization has been achieved. Pfizer and BioNTech submitted an EUA request to the FDA on November 20, and the FDA is set to meet on December 10 to discuss its potential approval.
“The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted,” said Stephen Hahn, FDA commissioner.
Moderna Submits EUA Request for COVID-19 Vaccine
In addition to Pfizer, the pharmaceutical giant Moderna is extremely confident that its vaccine is ready to save lives. “We believe our vaccine will provide a new and powerful tool that may change the course of this pandemic,” stated CEO Stephane Bancel.
Moderna’s experimental vaccine, mRNA-1273, has been ‘generally well tolerated,’ with no reports of serious safety concerns or side effects. As with Pfizer’s trial, Moderna’s vaccine efficacy proved consistent across age, race, ethnicity, and gender. Of the 196 cases of COVID observed, 185 occurred in the placebo group compared to 11 cases in the vaccine group.
After requesting an emergency use authorization on November 30, Moderna must wait until the FDA meets to discuss its data and potential approval on December 17. The Phase 3 trial, meanwhile, will continue through 2022 to collect 24 months’ worth of data after the second vaccine dose is administered.