RIO DE JANEIRO, BRAZIL – The United States and Europe are in line to receive the first doses of an experimental coronavirus vaccine after a partnership between Pfizer and BioNTech yielded excellent preliminary results in a large-scale patient trial.
Regulators on both sides of the Atlantic Ocean are working to expedite a review of the vaccine’s safety and efficacy after data showed it prevented infection in over 90 percent of cases. The data released on Monday placed both pharmaceutical laboratories firmly in the lead in the race to release a vaccine, topping Moderna and AstraZeneca.
Should the results be confirmed, Pfizer and BioNTech are committed to providing hundreds of millions of doses of the vaccine to countries struggling to fight a resurgence of the virus and eager to begin vaccination campaigns as soon as possible.
The companies have signed advance purchase agreements for 100 million doses with the United States and for twice that amount with the European Union, with options to purchase more. Initially, the supply will be highly insufficient.
The partner companies said they will be able to produce enough to immunize 25 million people this year, less than a third of the population of Germany, where BioNTech is based.
The distribution challenge
“We must find a way to distribute this fairly,” said BioNTech’s CEO Ugur Sahin in an interview. While the timing for approval depends on local regulators, there is no reason for one to significantly delay the other, he said.
Pfizer has said it will ship the vaccine to the U.S. Food and Drug Administration (FDA) for emergency use approval once an average of two months of safety monitoring data is available, which will likely occur next week. The European Medicines Agency already began an ongoing review of the experimental vaccine last month.
The partner companies expect to significantly increase production next year, with a capacity of up to 1.3 billion doses. The vaccine requires deep freezing in long-term storage, which could hamper distribution, although it can be kept at refrigerator temperature for at least five days.
BioNTech is working with Shanghai Fosun Pharmaceutical Group Co. to deliver the vaccine to China. An initial patient trial phase began there in August. The company is currently engaged in talks with the country’s drug regulator on the use of some of the late phase trial data available to support a regulatory submission in China, according to BioNTech.
The United Kingdom signed its own agreement for the supply of 30 million doses. Japan also has an agreement with the pharmaceutical companies, as does Canada.
Europe
“According to my information, the respective contract is about to be signed,” said Peter Liese, the EU Parliamentarian leading the health issues of the European People’s Party, the largest voting bloc in the European Parliament. “There is an agreement for the Europeans to receive hundreds of millions of vaccines,” he added in a statement sent by email.
A Commission spokesperson refused to comment on whether Pfizer’s announcement about the efficacy of its vaccine would expedite the signing of a supply agreement. The Commission has previously said that the 27 EU states would also be able to order another 100 million doses of the Pfizer and BioNTech vaccine.
The EU has already signed supply agreements with AstraZeneca, Sanofi, and Johnson & Johnson for their potential COVID-19 vaccines.
Source: infobae