Pfizer, BioNTech Provide Additional COVID-19 Vaccine Doses, Extend Clinical Trials to Younger Patients

The clinical trial expansion is part of efforts to detect potential adverse effects in children, such as heart inflammation problems.

Pfizer and BioNTech are providing an additional 200 million COVID-19 vaccines to the United States, according to a press release,1 and will be expanding their clinical trials of the vaccines in children 5 to 11 years of age.2

The additional doses are expected to be delivered from October 2021 through April 2022, bringing the total number of doses to 500 million.1 These doses were provided under the companies’ existing supply agreement with the US government and are in addition to the 500 million doses expected to be provided for donation to the world’s poorest nations, according to the press release.1

“As a long-term partner to the US government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country,” said Albert Bourla, DVM, PhD, chairman and chief executive officer of Pfizer, in the press release. “Vaccines have been and will remain critical to protecting lives against this devastating disease. These additional doses will help the US government ensure broad vaccine access into next year.”1

The companies plan to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses expected by April 30, 2022. The government also has the option to acquire updated versions of the vaccine that could address potential variants, if available and authorized.1

In addition to purchasing the additional doses, government agencies have urged Moderna and Pfizer-BioNTech to expand the size their clinical trials among children 5 to 11 years of age. According to reporting by The New York Times, this expansion is part of an effort to detect rare adverse effects in this patient population, including heart inflammation problems that have been seen in individuals 30 years of age and younger.2

According to the report, officials at the FDA believe that the scope of the original trials was inadequate to detect the adverse effects. Because of this, the FDA has asked the companies to include 3000 children between 5 and 11 years of age, which is approximately double the original number of study participants planned.2

Moderna’s clinical trial in children began enrolling participants in March, with the goal of enrolling 6795 participants between the ages of 6 months and less than 12 years. According to the Times, the company hopes to seek emergency authorization in this age group toward the end of 2021 or beginning of 2022.2

Pfizer and BioNTech may be able to accomplish these clinical trials sooner, possibly filing a request to expand the emergency use authorization of its vaccine by the end of September. The company previously planned to have results for children 5 to 11 years of age in September, followed shortly after by results for children ages 2 to 5. Results for children between the ages of 6 months and 2 years are expected in October or November.2

REFERENCE

1. Pfizer and BioNTech To Provide US Government With An Additional 200 Million Doses of COVID-19 Vaccine to Help Meet Continued Need for Vaccine Supply In the US. News release. Pfizer. July 23, 2021. Accessed July 26, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-us-government-additional-200

2. Stolberg SG, LaFraniere S, Weiland N. At the FDA’s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11. New York Times. July 26, 2021. Accessed July 26, 2021. https://www.nytimes.com/2021/07/26/us/politics/fda-covid-vaccine-trials-children.html?action=click&module=Spotlight&pgtype=Homepage