Pfizer CEO Albert Bourla announced on Tuesday that the United States Food and Drug Administration (FDA) could authorize its COVID-19 vaccine for children aged 12 to 15 by next week.
Bourla’s announcement was made in a conference call with investors, during which he delivered updates on the vaccine’s rollout in the US.
“We expect to hear back shortly from the FDA on our application for expanded Emergency Use Authorization for our COVID-19 vaccine to include individuals 12 to 15 years of age,” Bourla said, according to minutes from the meeting.
A US government source confirmed to CNN that this announcement was accurate. They added that for Pfizer to obtain the emergency authorization it mentioned, it would require an update to the current status its vaccine now holds.
The FDA is currently reviewing the data submitted to it by Pfizer but declined in a comment to CNN to say just how long this would take. According to data submitted to the FDA by Pfizer, the clinical studies for use on 12 to 15 year olds shows a “100 percent efficacy rate.”
COVID-19 vaccines in the US are currently only available for those 16 and older.
Bourla discusses vaccines for children younger than 12
Bourla said in his conference call to investors that the vaccine’s clinical testing on children aged 6 months to 11 years of age is ongoing. He also included a tentative timeline for when Pfizer expected results to be available for two groups — children aged 6 months to 5 years, and those 6 to 11 years of age.
“We expect to have definitive readouts and submit for an EUA for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children six months to two years old are expected in the fourth quarter,” Bourla noted.
Pfizer’s predictions come at a time when children represent a growing proportion of cases in the US. The American Academy for Pediatricians estimate that children now make up 22.4 percent of new infections.
Pfizer seeks vaccine authorization for kids in European Union
In Europe, Pfizer and its partner BioNTech have also asked for regulatory approval for COVID-19 vaccines for children, Deutsche Welle reported last Friday.
The two companies are looking to get the nod from the European Medicine Agency for a vaccine that can be administered to children aged 12 to 15 once the safety trials are completed. BioNTech CEO Ugur Sahin confirmed that he expects the vaccine to be available by June.
Sahin explained that the company was following a tentative timeline for ensuring children of all ages can get the vaccine pending EU approval.
Under their schedule, the companies expect children in the 5 to 12 age group to receive the vaccine by July. Those younger, from six months of age and upwards, would then receive their shots by September. This roughly agrees with the timeline shared by Bourla this week.
The EU has increasingly turned towards Pfizer as a source of its COVID-19 vaccines, a shift away from its previous supplier, AstraZeneca.
AstraZeneca had at one time committed to deliver 120 million vaccine doses by the end of March but in actuality only delivered 29.7 million inoculations by that deadline. The EU has almost 448 million residents — more than one hundred million more than the US population of 328 million.
Last week the EU initiated a lawsuit against AstraZeneca for what it says has been the company’s failure to honor its contractual obligations.
In the meantime, Pfizer agreed to supply the EU with 1.8 billion doses of its vaccine through 2023. This represents the largest deal to date for COVID-19 vaccinations.
Bourla predicts “durable demand” for vaccine
In a sign that COVID-19 will remain a concern in the near future, Bourla predicted that demand for his company’s vaccine will be “durable.”
Comparing this level of demand to that for the flu vaccine, Bourla said Pfizer anticipates that it would remain a long-term partner for governments in combatting COVID-19.
“We want to be a long-term partner to health authorities around the world in their ongoing efforts to combat COVID-19, including their planning of an ongoing pandemic vaccination approach that is fit-for-purpose to local requirements,” said Bourla.
Based on these predictions, Bourla predicts that Pfizer and its partner BioNTech expect to have the capacity to produce 3 billion doses by 2023.