The US government reports the shipment of the first 2.9 million doses of Pfizer’s and BioNTech’s, COVID-19 vaccine, BNT162b2, in the US. The companies received emergency use authorization for the vaccine from the US Food and Drug Administration (FDA) last week (December 11, 2020), making it the first COVID-19 vaccine to be authorized in the US. The vaccine is approved for individuals 16 years of age and older.

The update came from officials from the US Department of Defense (DoD), Operation Warp Speed, a US government initiative to speed the development of treatments and vaccines for COVID-19, and the Department of Health and Human Services (HHS). The update, provided at press briefings this week (December 14 and December 16, 2020), were from Army General Gus F. Perna, Chief Operating Officer of Operation Warp Speed, who was joined by HHS Secretary Alex M. Azar II and Dr. Moncef Slaoui, Chief Advisor, Operation Warp Speed.

The first shipment of 2.9 million doses of the vaccine, which is given in a two-dose regime, was made this week (as reported on December 14, 2020). The Centers for Disease Control and Prevention, in collaboration with CVS Pharmacy, Walgreens Company, other pharmacies, and US states established a strategy to get the vaccine to long-term health care facilities and first-line medical personnel, who will be the initial priority groups to receive the vaccine. Another 2.9 million doses are being held back to ensure those people receiving the first dose get the second dose in 21 days. An additional two million doses are expected to be delivered next week (December 21-23, 2020). HHS Secretary Azar said the US government will provide updates each Friday on the new numbers of vaccines that are being made available.

Pfizer and BioNTech previously formed a supply pact with the US government for its COVID-19 vaccine. In July (July 2020), Pfizer and BioNTech announced an agreement with the HHS and the DoD for an initial order of 100 million doses of the vaccine for $1.95 billion with an option by the US government to acquire up to 500 million additional doses.

Pfizer’s and BioNTech’s COVID-19 vaccine is one of several vaccines in which the US government has secured purchasing agreements. “Pending the successful authorization of other vaccine options, we have enough vaccines already purchased to ensure we can meet our goal of vaccinating every American who wants it by the end of the second quarter of 2021,” HHS Secretary Azar said at the December 14, 2020 press briefing.

The DoD is using a software platform that was specifically designed under Operation Warp Speed to distribute COVID-19 vaccines. The software, called Tiberius, provides visibility of each effort within Operation Warp Speed, from manufacturing and allocation of the vaccine to granular planning of vaccine administration sites to the provider level, incorporating information from sources, including the US Census, the Vaccine Tracking System, and commercial logistics companies. Jurisdictions, which include 64 jurisdictions representing US states, territories, and large metropolitan cities, work inside the Tiberius platform. They will determine, based on guidance from the FDA and emergency use authorization, along with recommendations from the CDC and the CDC’s Advisory Committee on Immunization Practices, how to prioritize the administration of vaccines.

EMA scheduled to review the vaccine next week

Pfizer’s and BioNTech’s COVID-19 vaccine, BNT162b2, now has been authorized or approved for emergency use in six countries (as reported on December 14, 2020): the US, the UK, Canada, Mexico, Saudi Arabia, and Mexico, and regulatory submissions and review are ongoing globally.  

Last month (November 2020), Pfizer and BioNTech submitted an application for conditional marketing authorization application with the European Medicines Agency (EMA). The Committee for Medicinal Products for Human Use (CHMP) of the EMA will meet next week (December 21, 2020) for an assessment of the vaccine with an additional meeting, if needed, scheduled for December 29, 2020. If the CHMP recommends marketing authorization, the European Commission will then fast-track its decision-making process with a view to granting a marketing authorization valid in all European Union and European Economic Area member states within days of approval, says the EMA.

Source: US Department of Defense (Dec 14 press briefing, US Department of Defense (Dec. 16 press briefing), US Department of Defense (Dec. 16 briefing logistics), and the European Medicines Agency