Pfizer expects to roll out only 50% of coronavirus vaccine doses it had planned globally by 2020-end: Report
US drugmaker Pfizer expects to ship just half of the coronavirus vaccines it had originally planned for 2020 due to supply-chain problems. Pfizer and its partner BioNTech wanted to roll out 100 million vaccines globally by the end of this year, a plan that has now been cut to 50 million, according to a report. The company found that raw materials in early production did not meet its standards.
“We were late. Some early batches of the raw materials failed to meet the standards. We fixed it, but ran out of time to meet this year’s projected shipments,” a person directly involved in the development of the Pfizer vaccine told the Wall Street Journal (WSJ). The company, however, did not specify what shortfalls over ingredients and raw materials took place as it ramped up production.
Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021, which will be subject to manufacturing capacity and regulatory approval or authorization, announced the companies. “Scaling up the raw material supply chain took longer than expected. And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection,” explained a company spokesperson.
In November too, Pfizer had publicly said that it planned to ship 50 million vaccine doses this year. Yet Pfizer shares fell on December 3 after the WSJ report was published.
Pfizer has applied to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of its vaccine candidate. The US government has placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses of Pfizer vaccine candidate. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA will meet on December 10 to discuss its EUA request. “We have contracted with Pfizer for 100 million doses and that will start rolling to us 20 million a month. Pfizer’s projected approximately 40 million doses by the end of this year,” US Secretary of Health and Human Services Alex Azar had said in November.
The UK on December 2 granted emergency-use authorization for Pfizer’s vaccine, becoming the first Western country to do so. “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic,” the companies noted.
Scientists had earlier explained that there may be logistical and distribution challenges with Pfizer’s vaccine. This is because the vaccine has to be stored and shipped and moved at ultra-cold temperatures — minus 94 degrees Fahrenheit or minus 70 degrees Celsius — which could make it hard to get to some places quickly. Pfizer has, however, assured that it has expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months.
“Pfizer is confident in its vast experience, expertise, and existing cold-chain infrastructure to distribute the vaccine around the world. The companies have developed specially designed, temperature-controlled thermal shippers, utilizing dry ice to maintain temperature conditions of -70°C±10°C. They can be used as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network,” Pfizer had earlier stated.
The companies also informed that through its existing production sites in Mainz and Idar-Oberstein, Germany, BioNTech can produce the vaccine for commercial supply after having already produced the vaccine candidate doses for the clinical trials. BioNTech will also increase its manufacturing capacity in 2021, once a third site in Germany will start manufacturing to provide further capacities for a global supply of the potential vaccine. “Critical to distribution in the UK will be Pfizer’s manufacturing site in Puurs, Belgium, one of Pfizer’s largest sterile injectable sites. The Puurs site is being used primarily for European supply but will also serve as back up supply to Kalamazoo, Michigan, for the US market,” said Pfizer.