THE Food and Drug Administration of the United States on Monday approved the world’s first COVID-19 vaccine, that of Pfizer-BioNTech, which will now be commercially available for individuals 16 years and older.
Pfizer and BioNTech said they plan to apply for full approval in children ages 12 to 15 as soon as required data is available.
The US FDA, which gave the two-dose vaccine emergency use authorization in December, provided its full approval for use in people age 16 and older based on updated data from the companies’ clinical trial and manufacturing review.
The Philippines’ Food and Drug Administration said it is expecting Pfizer to apply for a certificate of product registration (CPR) for its vaccine in the Philippines within a month or two.
The Philippines granted an emergency use authorization (EUA) for Pfizer-BioNTech’s COVID-19 vaccine last January. It expects the delivery today of 362,700 doses of Pfizer vaccines.
“We already sent them a list of the requirements in applying for a CPR,” said FDA Director General Eric Domingo. “They will be registering in the Philippines in one to two months.”
After filing the application, the Philippine FDA may take a month to make a decision.
“Before, vaccine application usually gets the approval in six months. But during the COVID-19 pandemic, it’s 30 days,” Domingo said.
Domingo expressed belief the US FDA’s grant of full approval to Pfizer-BioNTech’s vaccine will result in more countries granting it the full authorization.
“The US FDA is very strict… It will be successive applications for full authorization in different countries,” he said.
Domingo said other vaccine manufacturers may soon follow and apply for CPRs.
“Once one manufacturer gets a CPR, others will follow. They started their clinical trials almost at the same time. So their completion will more likely come at the same time,” he said.
With a COVID-19 vaccine now having full authorization, the public’s confidence in inoculation will get a timely boost, Domingo said.
“Public confidence will increase as they can see that the clinical trials are complete, it has undergone thorough review, and has passed safety and efficacy standards,” he said.
The government has administered 30.2 million vaccine doses, with about 13.2 million individuals completing the two doses.
The country has received 3.587 million doses of Pfizer vaccines, including the delivery today. It is expecting at least five million more doses from Sinovac and Moderna before the month ends.
The country has already received a total of 48.552 million doses, with 14.66 million delivered this month.
Vaccine Expert Panel member Dr. Rontgene Solante reiterated there is still no recommendation for booster shots and that vaccines being used in the government’s vaccination program are effective against symptomatic, severe and critical COVID.
Solante said records also show that majority of those being hospitalized for COVID, especially those with critical and severe COVID, are unvaccinated.
COMIRNATY
The US FDA said the Pfizer vaccine continues to be available under EUA, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“Today, the US Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older,” the US FDA said in its website.
US public health officials hope the full approval will convince unvaccinated Americans that Pfizer’s shot is safe and effective.
There is entrenched vaccine skepticism among some Americans, particularly conservatives.
COVID-19 cases, driven by the highly infectious Delta variant, have surged in parts of the United States with lower vaccination levels.
US health officials expect that the FDA’s action also will prompt more state and local governments, as well as private employers, to impose vaccine mandates. New York City said it will require vaccines for public-school teachers, while New Jersey announced that all state workers must get vaccinated by mid-October or agree to regular COVID-19 tests. — With Jocelyn Montemayor and Reuters
