Nanette Cocero, head of Pfizer’s vaccine program: “Our work is not over yet”

Washington dc – As global president of the vaccine business of Pfizer, the Puerto Rican Nanette Cocero US authorities expect to have between 20 and 25 million doses of the vaccine they have developed with the German company this month BioNTech to fight the coronavirus.

Doctor of Pharmacology, Cocero – born and raised in Puerto Rico – has been at the forefront at Pfizer of various tasks, including the pharmaceutical business operations in more than 100 countries in Latin America, Africa, the Middle East and Asia.

He now coordinates the company’s entire vaccine business worldwide.

At a time when Pfizer has begun delivering its vaccines to the federal government, Cocero – who has been working from the Island – responded in writing to a series of questions that The New Day sent it to you last week.

How many doses of the vaccine will be distributed in December to the United States? How many of those will be shipped to Puerto Rico?

—Pfizer and BioNTech expect to produce up to 50 million doses by 2020 and up to 1.3 billion doses by 2021 globally. In July 2020, Pfizer and BioNTech announced an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s “Operation Warp Speed” goal to begin to administer 300 million doses of a vaccine against COVID-19 in 2021. Following the agreement, the U.S. government will receive 100 million doses of (the vaccine) BNT162b2. The U.S. government also has the capacity to agree with Pfizer the acquisition of up to 500 million additional doses. Pfizer expects to make between 20 and 25 million doses available in December in the United States.

How to transport to Puerto Rico?

“Puerto Rico vaccines will be delivered by air from our plant in Kalamazoo, Michigan.” We expect to ship approximately 12 trucks and 20 aircraft with miles of vaccine environments daily.

If you can tell me the process of putting them in freezers. Are they Pfizer or order freezers?

—Pfizer has designed temperature-controlled thermal conveyors that use dry ice to maintain the recommended temperature conditions for the vaccine. Our specialized heat carriers are approximately the size of a suitcase and can weigh up to 81 pounds fully loaded. It is qualified to contain a minimum quantity of 195 vials and a maximum quantity of 975 vials.

Once a point of use receives a heat carrier with our vaccine, it has three storage options: ultra-low temperature freezers, which are commercially available and can extend the shelf life of doses up to six months; Pfizer thermal conveyors, in which the doses will arrive, which can be used as temporary storage units by filling them with dry ice every five days for a maximum of 30 days of storage and following the specified handling instructions; and refrigeration units commonly available in hospitals. The vaccine can be stored for five days in refrigerated conditions of 2 to 8 ° C.

The thermal conveyor can maintain the temperature for 10 days without being open, allowing transportation to markets around the world. Once opened, and if used as a temporary storage unit by a vaccination center, the carrier may maintain the recommended storage conditions (-70 ° C ± 10 ° C) for up to 30 days with ice filling. dry every five days according to handling instructions.

After storage of up to 30 days in Pfizer heat transport, vaccination centers can transfer the vials to storage conditions of 2 to 8 ° C for an additional five days, for a total of up to 35 days. . Once thawed and stored at 2 to 8 ° C, the vials cannot be re-frozen or stored under freezing conditions.

How is this process of transferring the vaccine from one freezer to another guaranteed to be done properly?

—We will use GPS thermal sensors on each thermal conveyor with a control tower that will track the location and temperature of each vaccine shipment on its preset routes, 24 hours a day, seven days a week. These GPS devices allow Pfizer to proactively prevent unwanted diversions and act appropriately according to the sea required.

Why should a person be protected with the Pfizer vaccine? What is the difference with other vaccines, for example, with Moderna?

-Both Pfizer and Moderna have vaccines based on mRNA technology (the new type of vaccine that protects against infectious diseases). The mRNA platform is suitable for a pandemic response on many levels.

First, a safety aspect: unlike some conventional vaccines, mRNA vaccines are not infectious and there is no need for a viral vector to administer them. Second, because no viral vector is used, mRNA vaccines do not present a risk of an anti-vector neutralizing antibody response, allowing for repeated rejection, which may be important if vaccines are recommended. additional in the future. Third, the speed, RNA technology allows for rapid development if the vaccine needs to adapt quickly to possible mutations. MRNA vaccines have an efficient production process, without the need for complex mammalian cell systems.

The British regulatory agency has indicated that people with a “significant history” of allergic reactions should not receive the new Pfizer-BioNTech vaccine. What does it answer?

-There were two reports of adverse events that may be associated with an allergic reaction due to the administration of the Pfizer and BioNTech vaccine. As a precautionary measure, the UK Medicines and Health Products Regulatory Agency (MHRA) issued a temporary guide while conducting an investigation to fully understand each case and its causes. Pfizer and BioNTech support MHRA research.

Meanwhile, product labeling approved by the FDA (Federal Food and Drug Administration) includes instructions for the vaccine not to be given to people with a known history of severe allergic reactions to any component of the vaccine . In addition, you will be advised that appropriate medical treatment must be available to manage any immediate allergic reactions. It is important to emphasize that in our Phase 3 clinical trial, which enrolled more than 44,000 participants, the Independent Data Monitoring Committee reported no serious problems with the safety profile of the vaccine.

With whom can Pfizer coordinate distribution in Puerto Rico, with the government or directly with hospitals and health centers?

-Pfizer coordinates with the Operation Warp Speed and, in turn, Warp Speed ​​coordinates all logistics with the state / territorial governments.

Is there an idea of ​​when the vaccines will be available en masse, meaning that a person can go to a pharmacy to get vaccinated?

-At Pfizer, we understand the overwhelming sense of urgency we all have to return to normal, from children returning to school full time and business operating as usual, to embracing our friends and family without fear. . We are incredibly proud of the unprecedented achievement of our scientists and colleagues working in our manufacturing plants responsible for bringing this medical innovation to market in less than a year, without cutting corners in the rigorous regulatory processes. and research and development.

For months, we have been working closely with international initiatives, governments and other stakeholders, as appropriate, to deliver the vaccine to the world as quickly as possible. We are encouraging the success of other companies in their vaccination efforts and we hope that science will overcome this coronavirus sooner rather than later.

While we hope and believe we have the tools to (leave behind) this pandemic, our work is not over yet. I recognize that there is fatigue from COVID-19, but I cannot stress enough the importance of not lowering my guard. Now, more than ever, as we get closer to the end-of-year festivities, it’s important that people continue to wear their masks, wash their hands, practice social distance, and follow the guidelines of the Centers for Disease Control and Prevention (CDC) for outdoor and small group meetings.