Dr. Anthony Fauci told CBS' "Face the Nation" Sunday that it is still the Biden administration's plan "in some respects" to begin the third doses the week of Sept. 20, pending approval by the Food and Drug Administration.
The administration had hoped that both Pfizer and Moderna booster shots would be rolled out at that time. But Fauci said it is "conceivable" that for Moderna's, there might be "at most a couple of weeks, a few weeks delay, if any," while the company provides more data to the FDA on the booster's efficacy.
President Joe Biden on Aug. 18 touted boosters as a protection against the virus' more transmissible delta variant, and said...
BACKGROUNDThe Pfizer–BioNTech COVID-19 vaccine
The Pfizer–BioNTech COVID-19 vaccine , sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. It is authorized for use in people aged twelve years and older in some jurisdictions and for people sixteen years and older in other jurisdictions, to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. For its development BioNTech collaborated with Pfizer, an American company, for support with clinical trials, logistics, and manufacturing. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial advice indicated that vaccination required two doses given 21 days apart, but the interval was later extended to up to 42 days in the US, and up to four months in Canada.
Clinical trials began in April 2020; by November 2020, the vaccine entered Phase III clinical trials, with over 40,000 people participating. An interim analysis of study data showed a potential efficacy of 91.3% in preventing symptomatic infection within seven days of a second dose. The most common side effects include mild to moderate pain at the injection site, fatigue, and headaches. Reports of serious side effects, such as allergic reactions, are very rare; no long-term complications have been reported. Monitoring of the primary outcomes from the trials will continue until August 2021, while monitoring of the secondary outcomes will continue until May 2023. As part of the updates for the Phase III clinical trials posted in June 2021, the assessment of biostability will be studied to further describe the potential protection given by the vaccine against emerging SARS-CoV-2 Variants of Concern.
The vaccine is the first COVID-19 vaccine to be authorized by a stringent regulatory authority for emergency use and the first cleared for regular use. In December 2020, the United Kingdom was the first country to authorize its use on an emergency basis. It is authorized for use at some level in the majority of countries. On 23 August 2021, the Pfizer–BioNTech vaccine became the first COVID-19 vaccine to be approved in the United States by the Food and Drug Administration for those aged sixteen years and older.
As of 30 March 2021, Pfizer and BioNTech aimed to manufacture about 2.5 billion doses in 2021. Distribution and storage is a logistical challenge because the vaccine needs to be stored at extremely low temperatures. BioNTech and Pfizer are testing a freeze-dried version that would not need ultracold storage.
Agreements with Moderna, Pfizer and AstraZeneca
With the CanSino deal falling through, and the VTF revising its recommendations based on clinical trial data from other countries, Minister of Public Services and Procurement Anita Anand announced on August 5, 2020 that the federal government had committed to purchasing doses of the Moderna and Pfizer–BioNTech vaccines. In anticipation of a COVID-19 vaccine, the Canadian government purchased more than 75 million hypodermic needles and syringes.
After the NRC found that its current lab would not meet good manufacturing practices Prime Minister Trudeau announced on August 31 a federal investment of $126 million to 'design, construct, commission and qualify a new biomanufacturing facilit'y—the Biologics Manufacturing Centre, which was projected to be completed by the end of July 2021. It would be built next to the NRC's current Royalmount site in Montreal and have a production capacity of approximately 2 million does per-month'.
In September 2020, the federal government committed to purchasing 20 million doses of the Oxford–AstraZeneca vaccine. It also announced that it would make a $440 million investment in the COVAX initiative, to help fund the equitable procurement of COVID-19 vaccines worldwide.
In November 2020, Conservative Party leader Erin O'Toole criticized the federal government for focusing too heavily on the CanSino agreement, arguing that he 'would not have put all our eggs in the basket of China.'