Why can the Pfizer / BioNTech vaccine never reach Brazilians?

Without mentioning any particular pharmaceutical company, Health Minister General Eduardo Pazuello criticized the promises made by some vaccine producers this morning during a press conference.

“There are very few manufacturers that have quantity and an effective delivery schedule for our country. When it comes to the end of the negotiations and moves on to delivery and manufacturing, the numbers are slim. It is a large amount that comes down to one, two, three companies. Most have very small numbers for our country ”.

The speech is in line with another demonstration made on Tuesday by Arnaldo Medeiros, secretary of Health Surveillance of the ministry. The representative said that Brazil would prioritize immunizers that fit into the infrastructure of vaccination rooms throughout the country.

“Fundamentally that she [a vacina] Be heat stable for long periods, at temperatures of two to eight degrees. Why? Because our cold chain, in the 34 thousand rooms, is assembled and established at approximately 2 ° C to 8 ° C “.

Later, in a video posted on the YouTube channel of the Ministry of Health, Medeiros pointed out that none of the most advanced competitors is eliminated from the government’s list of options.

“It is extremely important to inform the Brazilian population that the Ministry of Health, through the National Immunization Program, does not rule out any vaccine. What we want is a vaccine that is registered in Anvisa and that shows the necessary efficacy and safety.”

But what does this have to do with the recently approved UK Pfizer / BioNTech product? The big controversy is that their doses must be stored at -75 ° C, a temperature that requires special equipment. This requirement can make it difficult to transport and deliver doses to more remote regions with little infrastructure.

Other candidates, such as Sputnik V, CoronaVac and products developed by AstraZeneca / Oxford University or Johnson & Johnson require cooling in the 2 ° C to 8 ° C range, a value that is easily obtained with conventional refrigerators.

Through a note sent to the press, Pfizer gave its version of the events and complaints. The company says it has a detailed logistics plan and tools to transport, store and monitor doses at the recommended temperature.

“By understanding the challenges some vaccination programs might face, Pfizer has developed innovative boxed packaging in which the vaccine can be stored at -75 ° C for 15 days on dry ice.”

The company also argues that its vaccine, the results of which have already been sent for analysis by Anvisa, the National Sanitary Surveillance Agency, can remain in a common refrigerator for up to five days. “This makes vaccination feasible, especially in the current situation where the greatest number of people are intended to be vaccinated in a short period of time.”

Finally, the note highlights that other Latin American countries with a similar condition to Brazil, such as Chile, Peru, Mexico, Panama and Costa Rica, have already signed purchase agreements and are in a position to operationalize the application of doses from the beginning. 2021.

In recent interviews, the general director of the pharmaceutical company in Brazil, Carlos Murillo, said that he tried to speak with the Ministry of Health on several occasions during the second half of 2020 to negotiate the advance sale of doses of this vaccine against covid-19. According to the executive, the government did not respond to contacts.

More recently, some meetings were held between the government and the company, but until now there has not been a definition on the purchase of immunizer units or an eventual transfer of technology.

So even if Brazil reaches a deal with Pfizer and BioNTech in the next few days or weeks, it will be far behind the tail. The priority of delivery of the first batches will be to the nations that have anticipated their orders.

The availability of this immunizer in private clinics throughout 2021 is also remote. After all, manufacturing will be 100% focused on meeting the needs of governments around the world.

Another side to demonstrate in the last hours was the National Council for Air Conditioning and Refrigeration, which brings together the 15 largest entities in the sector in Brazil.

Through a statement, the agency ensures that the country has the capacity to provide the necessary technology to store doses of any vaccine, even if they need to be kept at -75 ° C:

“It is necessary to clarify that Brazil has a strong cold chain, with numerous manufacturers in the national territory, with available technology. In addition, the service sector has professionals with solid knowledge for very low temperature installations, so much so that cryogenic installations have been operating for many years in Brazil. Therefore, the national cold sector can adapt the infrastructure and provide solutions for any temperature, even -70 ° C, with planning and investment ”.

Since the first candidates evolved to phase 3 research, the last step before approval, the world has gone through a real dispute, in which each country plans to guarantee the doses of one or more pharmaceutical companies.

Some nations preferred to diversify their bets; after all, if an immunizer did poorly in clinical trials, there would be other backup options.

Canada is the best example of this: the agreement made by the governments of this country guaranteed an average of 9 doses of vaccine for each inhabitant, according to information compiled by the magazine. The Economist. Just behind are Australia and the United Kingdom, with five doses per person.

On the contrary, Brazil launched all its archives in partnership to buy and transfer technology based on the formulation developed by AstraZeneca and the University of Oxford.

Another important source of immunizers for the country is the Covax Facility, an initiative of the World Health Organization to distribute some of the vaccines to less developed nations.

There are still some agreements made by the States. This is the case of Paraná and Bahia, which have a signed contract to receive Sputnik V from the Gamaleya Research Institute in Russia in the future.

The scenario is similar to that of CoronaVac, from the Chinese laboratory Sinovac, which signed an agreement with the Butantan Institute in São Paulo.

Before applying any vaccine, it is necessary that the preliminary phase 3 studies, which prove the efficacy and safety of the product, be disclosed. This step has already been achieved by four competitors: Pfizer / BioNTech, Moderna, Gamaleya Research Institute and AstraZeneca / Oxford University.

The first three had an effectiveness rate of over 90%, which was considered optimal. In the case of AstraZeneca / Oxford University, exactly the bet of the Ministry of Health, there was an error in the performance of clinical tests. This raised some doubts about the results and may delay your arrival a bit.

When this scientific work is completed and has reached its objectives, the documents and reports are sent to the regulatory agencies, which evaluate the robustness of that information and decide whether or not the vaccine can be used in a specific place. It happened today in the United Kingdom, the first country to give the green light to a vaccine against covid-19 in the world. In Brazil, the body responsible for this process is Anvisa.

Once released, the immunizer can finally be imported or manufactured and distributed to finally be applied to people.

Given the latest information, the climate for now is uncertain: we still do not know which of the vaccines will actually be used in the country. This will depend on the progress of the investigation and, of course, on the negotiation that the Ministry of Health will carry out from now on.

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