By Betsy Klein and Naomi Thomas, CNN
The Biden administration purchased an additional 200 million doses of Pfizer-BioNTech’s Covid-19 vaccine to prepare for potential additional vaccine needs in the US, an administration official familiar with the contract tells CNN.
Despite the slowing demand for Covid-19 vaccines, the administration official said the additional shots would be needed for children under 12, pending approval from the US Food and Drug Administration, and the possibility of booster shots for vaccinated individuals.
“The federal government is exercising an option in its contract with Pfizer to purchase 200 million doses of the Pfizer vaccine to be delivered between fall 2021 and spring 2022 to prepare for future vaccination needs, including vaccines for children under 12 and possible booster shots if studies show they are necessary,” the official said.
The official noted that Pfizer has agreed to “provide the US with 65 million pediatric doses should its vaccine be approved for kids under 12, including doses available immediately upon authorization.”
Currently, none of the three Covid-19 vaccines used in the US is available to children under the age of 12. With many schools across the United States now just weeks from reopening for the fall semester, Pfizer, Moderna and Johnson & Johnson are still conducting clinical trials to evaluate the safety and efficacy of the vaccines in children under 12.
Data for children ages 5 to 11 could come sometime in September, and depending on the findings, Pfizer told CNN it could ask the FDA to authorize emergency use of the vaccine that same month. Data for 2-to-5-year-olds could arrive soon after. For the youngest children, Pfizer said it could potentially get data in October or November, and shortly thereafter ask the FDA to authorize emergency use.
Dr. Anthony Fauci said Tuesday said it is “very likely” that data about Covid-19 vaccines in children under 12 may be available by early winter.
“Very likely when you do the age de-escalation study — so we’ve gone from 12 to nine, nine to six, six to two and then six months to two years — likely by late fall, early winter, we’ll have enough data,” Fauci, the director of the National Institute of Allergy and Infectious Diseases, said at a Senate hearing. “But that doesn’t mean that then it’s all of a sudden going to be allowed to happen. That will be a regulatory decision that the FDA will have to make,” he said.
A news release from BioNTech release said that 110 million of the additional doses are expected to be delivered by December 31, 2021, and the remaining 90 million no later than the end of April 2022. The US government also has the option to acquire updated versions of the vaccine if they are available and authorized.
This new purchase brings that total number of doses supplied by Pfizer/BioNTech to 500 million. In June, the US announced they intended to purchase an additional 500 million doses of the vaccine to then be donated to other low and lower-middle income countries.
Demand for Covid-19 vaccines in the US has waned considerably since the initial rollout. An average of 252,232 people are becoming fully vaccinated each day, according to the US Centers for Disease Control and Prevention. This is the slowest pace of vaccinations since January. About 49% of the country is fully vaccinated.
“As a long-term partner to the U.S. government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country. Vaccines have been and will remain critical to protecting lives against this devastating disease,” said Albert Bourla, Chairman and CEO of Pfizer in the release. “These additional doses will help the U.S. government ensure broad vaccine access into next year.”
“It has been our consistent goal to supply as many doses of our COVID-19 vaccine as possible to people around the world to help bring an end to this pandemic,” said Dr. Ugur Sahin, CEO and Co-founder of BioNTech, also in the release. “We are honored to support the U.S. and more than 100 countries in their continuing vaccination programs.”
President Joe Biden predicted during a CNN town hall earlier this week that children under 12 would be approved to receive the vaccine “soon” by the FDA, adding that it will be up to the scientists to decide.
“Soon, in the sense that I do not tell any scientists what they should do. I do not interfere. So, they are doing the examinations now, the testing now, and making the decision now,” he said, adding that scientists will make a decision “when they are ready” and have “done all the science that needs to be done” to determine the appropriate vaccination for different age groups.
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