RIO DE JANEIRO, BRAZIL – Pfizer expects to be granted registration of its vaccine against Covid-19 by the Food and Drug Administration (FDA, U.S. Department of Health agency) in December, which would enable it to initiate vaccination in the United States still this year.
By attending an online symposium promoted by the National Academy of Medicine, the company’s CEO in Brazil, Carlos Murillo, said that 50 million doses will be available this year, and the total for next year will reach 1.3 billion doses worldwide.
“In the case of Brazil, we are still working closely with the Brazilian government in an attempt to expedite availability as quickly as possible. I hope that in the first quarter of next year we could be relying on this vaccine to be available in Brazil,” said Murillo, who explained that the company and the government are still negotiating.
Pfizer projects that the requirements demanded by the U.S. regulatory agency to complete the registration process should be ready by the third week of November. From then on, the FDA assessment should take around one month and the granting of the registration for emergency use should occur still in 2020.
Pfizer/Biontech clinical trials involve some 44,000 people, 3,000 of whom in Brazil. One of the FDA requirements is that half of the study subjects have been administered the vaccine at least two months ago. The other requirement is that at least 164 trial subjects develop the disease, given that half of the volunteers have not been immunized.
The importance of placebo administration in half of the trial subjects consists in comparing whether the immunized group was in fact protected, since they were exposed to the disease in the same region and in the same period as the non-immunized patients. When the preliminary results were released earlier this week, which showed efficacy of over 90 percent, the number of volunteers who developed Covid-19 stood at 94, short of the desired number.
The vaccine under development by Pfizer, in partnership with the German Biontech, has been undergoing clinical trials in Brazil since July and will also require registration at the National Health Regulatory Agency (ANVISA). Like the European regulatory authority, ANVISA has implemented a model of continuous submission, in which the documents required for registration start to be assessed in stages, before the completion of trials.
According to Pfizer’s Murillo, from the conclusion of phase 3 trials, still this month, all documents will be forwarded to ANVISA.
The company is also negotiating with the Brazilian government the option of supplying the vaccine to the National Health System (SUS). Unlike the Sinovac and AstraZeneca/Oxford vaccines, the agreement should not provide for technology transfer at first, because, according to Murillo, Pfizer and Biontech chose to centralize production in their plants in the United States and Germany during the pandemic.
“In the first stage, production is centralized. It is the fastest way to release the vaccine. After the pandemic, Pfizer will assess and consider options that allow technology transfer, like Brazil.”
Because it is still in negotiations with the Brazilian government, the executive preferred not to disclose the price of the vaccine, but said that there are three price ranges offered to the global market: one for developed countries, one for middle-income countries such as Brazil, and one for poorer countries. According to Murillo, Pfizer invested US$2 billion (R$10 billion) of its own resources in vaccine development.
The unprecedented technology of the Pfizer/Biontech vaccine, from the RNA messenger, presents a logistic challenge: the doses need to be refrigerated in freezers much more powerful than those available in vaccination posts. To bypass the difficulty, the pharmaceutical company has been working with partners to develop a special package that allows the vaccine to be kept at minus 70 degrees Celsius (-70°C) for up to 15 days with dry ice.
“The scientific advances are being observed in terms of the vaccine and also in terms of logistics,” said Murillo, who has already presented the package to the Brazilian government. “It is not a straightforward issue and does not solve the logistics, but it greatly reduces the problem of considering that a country would need an ultra-freezer for each vaccination center”.
The pharmaceutical company’s proposal is to negotiate the packages together with the vaccines, so they can be delivered this way to vaccination centers. After being removed from this package, the vaccine can be stored in a common refrigerator for up to five days.
Source: Agência Brasil