Pharmaceutical Pfizer hopes to rapidly roll out its COVID-19 disease vaccine in Latin America after U.S. health regulators authorize its emergency use, which could happen next month, a senior executive of the company assured last Friday.
Alejandro Cané, Head of Scientific Research and Medical Affairs at Pfizer’s Vaccines Division, told . that the countries of Latin America and other regions should have “similar timelines” to the United States.
“The idea is to have the vaccine licensed in the United States”, Said Cané in Buenos Aires. “We are sure that in the next few weeks or months we are going to have the vaccine not only in use in the United States and Europe, but also in Latin American countries“, he claimed.
Alenadro Cane. Buenos Aires, Argentina. November 2020. REUTERS / Agustin Marcarian
Pfizer has already conducted a formal request to the United States Food and Drug Administration (FDA, for its acronym in English) so that authorize emergency use of your coronavirus vaccine. Is the first request of this type and a crucial step to offer protection against disease.
“We are awaiting comments from the FDA to have a meeting with the Advisory Committee on Vaccines and Related Biologicals (VRBPAC in English) and then a potential authorization for emergency use ”, Cané explained. “That way, the vaccine could be used and distributed in the United States,” he added, while estimating that the authorization could be finalized. one or two weeks after meeting with the Committee.
The Pediatrician and Infant Infectologist at the Austral University Hospital pointed out that Pfizer has supply agreements with Chile, Mexico and Peru and that there are other conversations in progress. The president of Argentina, Alberto Fernández, said this week that his vaccine could reach the country in December.
The American Pharmaceutical and Her German Partner BioNTech SE have reported the final results of the trial, which show that the vaccine was 95% effective in the prevention of COVID-19 without major security problems.
REUTERS / Dado Ruvic
Cané expressed that Pfizer is ready to supply and distribute about 50 million doses of the vaccine by the end of 2020 to be divided between the United States and the rest of the world. In addition, he added that the vaccine demonstrated high efficacy in different ethnic groups.
The company aims to supply some 1.3 billion doses by the end of next year.
Regarding the need to keep the vaccine at ultra low temperatures, what generates complications in less developed regions such as Latin America, Cané explained that the company hopes to have a second generation of the vaccine by 2022.
“We know that it is complicated compared to other vaccines, but we are in the middle of a pandemic situation and we are trying to provide the most effective solution in the fastest way, “he said.
In Latin America, several countries have agreements to obtain doses of the Russian vaccine Sputnik V and other companies such as the British AstraZeneca Plc and China’s Sinovac Biotech.
Following the request for emergency authorization of its vaccine against COVID-19 disease by Pfizer and BioNTech, a key step on the way to approval is a FDA external advisers meeting, all experts in infectious diseases and vaccines. They are expected to attend conferences from December 8 to 10, according to a person with knowledge of the situation, maintains the US media Bloomberg. FDA will dedicate the weeks between the emergency clearance request and the meeting to classify the trial data.
United States Food and Drug Administration (FDA) . / Michael Reynolds
“I don’t find that time frame unreasonable in light of the amount of data the agency needs to analyze and to ensure full participation of all stakeholders on the advisory committee,” he said. John taylor, who served as an advisor to the FDA chief during the Obama administration and now works as a consultant at Greenleaf Health. “It guarantees that the agency can have a well-run and well-attended advisory committee in order to ensure the maximum transparency, which I believe will be an important factor in the willingness of patients to get vaccinated”He added.
The FDA holder, Stephen Hahn, also noted earlier this week that the agency will release documents related to its review of any vaccines that have been granted an emergency clearance. The objective is “contribute to public confidence in the agency’s rigorous review of scientific data and the appropriate use of licensed products”.
WITH INFORMATION FROM REUTERS AND BLOOMBERG
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