The FDA has granted approval to the Regen-COV2 antibody vaccine, which reportedly aided in President Donald Trump’s recovery from COVID-19.
With the country’s COVID-19 cases hitting the 12-million mark, government drug regulators have given the green light for emergency use of an antibody therapy in a bid to curve the alarmingly rapid rise of cases in the United States.
On Friday, the US government, through the US Food and Drug Administration, gave approval to Regeneron’s “antibody cocktail” to be used as soon as possible to address the rising number of cases in the US.
The Regen-COV2 cocktail is designed to give the immune system a means to accurately tag the COVID-19 virus as a threat, and launch a response as soon as the virus is seen in the bloodstream to keep it from attaching to healthy lung cells.
The Regen-COV2 cocktail reportedly is behind President Donald Trump’s rapid recovery after being diagnosed as positive for the coronavirus.
FDA commissioner Stephen Hahn said that the approval of emergency use for the Regen-COV2 vaccine could help ease the burden off the health care system. With the vaccine in distribution, outpatients who are tested positive for the COVID-19 can instead receive the vaccine and not be admitted to a hospital.
Regeneron claims to have around 80,000 doses ready by end of next month. By January, the number of available doses could go up to 300,000.
Thanks to a government programme, the vaccine can be available to the general public at no cost.
Regeneron is the second company to receive such approval, after Eli Lilly received a similar permission in November 9.
Meanwhile, American companies Pfizer and Moderna are also in the race to receive emergency approval for their RNA messenger vaccines. Both companies have released preliminary results of their initial testing on humans showing more than 90% effectiveness rate.
Messenger RNAs are molecules carrying specific genetic codes, which are read by ribosomes. Ribosomes are responsible to protein synthesis in the cell creation process.
Messenger RNA vaccines, in theory, could help the body build a stronger defense against the COVID-19 by specifically influencing the immune system to create its own vaccines modeled after the initial genetic code carried by the vaccine.
FDA’s advisors will convene on December 10 to discuss the two messenger RNA vaccines and decide whether they will give a similar approval to both Pfizer and Moderna.
According to White House COVID-19 task force head Moncef Slaoui, they are aiming to enable shipment of vaccines to immunization sites as fast as 24 hours after the US Food and Drug Administration issues approval.
G20 leaders also met over the weekend in order to discuss various issues, including equitable distribution of vaccines. The body unilaterally agreed to ensure “affordable and equitable access” worldwide to any vaccine that is given approval.
This includes plugging a $4.5 billion funding shortfall, although the document from the meeting promised that the G20 has mobilized the necessary resources to “address the immediate financing needs” related to development and distribution of future COVID-19 vaccines.
French President Emmanuel Macron said that there is no more effective response to the current pandemic than a “global response,” which is what the G20 needs to make.