Pfizer-BioNTech's vaccine becomes the first COVID vaccine to be granted full approval by the US FDA (Food and Drug Administration).
The US FDA made the announcement on Monday, 23 August, with a statement that also says the vaccine will now be marketed as Comirnaty (koe-mir’-na-tee).
This approval replaces its earlier emergency use authorisation status, essentially lifting the restrictions that come with an EUA.
This approval also comes quickly in the heels of the US government recommending a third booster dose of the vaccine, as an added protection against the Delta variant.
It is hoped by the US health authority that the full approval from the FDA would dispel vaccine hesitancy among some Americans.
"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated."Acting FDA Commissioner Janet Woodcock said in the statement
What Does ‘Full Approval’ Mean?
Because of the gravity of the pandemic, COVID-19 vaccines were rolled out around the world under emergency use authorisation, so that the process of getting them to people could be fast tracked.
Emergency use authorisation is essentially a 'short-cut' (and limited) approval that is given on the basis of the safety and efficacy data collected in clinical trial results by weighing the risk to benefit at a time of public health emergency.
Full approval, on the other hand, is a long route that requires a much more thorough review.
Before granting this, the FDA said they reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
"Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older."The US FDA in their statement.
The review also found that the vaccine showed a 91 percent effectiveness in preventing COVID-19 disease.
Although the Pfizer vaccine is available under EUA for everyone over the age of 12, the vaccine has only received full approval for use in those aged 16 and above.
One reason for this could be that a higher risk of myocarditis and pericarditis—particularly after the second dose—was observed in (mostly males) between the ages of 12 and 17 years.
How Does a Full Approval Change Things?
For one, it is hoped that the full approval will put at ease the minds of those who are sceptical about the safety of the vaccine and encourage more people to get vaccinated.
Something that is pertinent right now, when cases of the Delta variant are skyrocketing in the US, and more and more young people are being hospitalised due to a low vaccine coverage.
Full approval also allows the company to advertise the vaccine, and keep selling it after the period of public health emergency passes.
Private healthcare facilities can now directly place orders and sell the vaccine without state intervention and control over the supply.
Moreover, full approval also means that workplaces and educational institutes in the US can now require people to be vaccinated by mandate.
It must also be noted that this applies only to the US, as every country has their own regulatory body that green lights drugs and vaccines. In India, this decision is taken by the Drugs Control General of India.
So far, no COVID vaccine has received full approval from the DCGI and are being administered under emergency use authorisation only.