This article highlights the challenges faced by one of the Covid 19 vaccine developers of the world Pfizer. We know that Pfizer, the New York based global pharma MNC giant employing 79,000 people across 125 countries has been successful in coming up with a vaccine against the Covid 19 virus. Pfizer had revenues in 2020 of $42 billion.
The Covid 19 vaccine BNT162b2 developed by Pfizer with German BioNTech has shown efficacy of 91.3% measured from six days to 3 months after the second dose. (click here) This article outlines some of the challenges faced by vaccine developers, and more so, when time is scarce and the mortality is increasing daily.
We know vaccines take anywhere up to 8-10 years to develop. How did Pfizer manage this in about 10 months without much of complications, delays or bureaucratic interference ? How did they manage the testing phases trials 1, 2, 3 and 4 effortlessly and successfully ? The Pfizer CEO Albert Bourla happened to write in HBR of May 2021 (click here) in very clear and simple language how he managed to get the vaccine development done in a short span of about 8 months, when all the odds were against it. He stresses on the patient first mentality.
Leadership mattered very much. Pfizer working alone being successful was a distant reality. Pfizer had the concerns of mankind in mind, in this case, more than any immediate returns or patents. This prompted Pfizer to pump in almost $3 billion for this project. Since it was hard pressed for time and talent doing it alone, it joined hands with BioNTech of Germany, who had the expertise of doing synthetic vaccines using messenger RNA (mRNA) technology.
A vaccine is just weakened forms of the virus (or whatever pathogen it is dealing). In this case the vaccines are prepared synthetically by mRNA technology using the pathogen's genetic code, and it helps speed up the process. No vaccine developed through the mRNA technology had ever been approved till then in the world. The efforts that started around March '20, found BioNTech joining by April.
Normally the trials would first start with animals and then four sets of human trials on limited than large samples. The tests are also done on placebos to check the efficacy of the virus. It is very difficult to get the required permissions and sanctions from the regulatory agencies, more so with US Federal Drugs Administration. Being an emergency and the okay from US FDA and German regulatory authorities coming fast, the tests on large animals and phase 1 on about 20-100 human samples were done simultaneously. The main objective of this vaccine development was to come up with a new vaccine after finishing the mandated trials in as short a time as possible.
Similarly Pfizer request to the authorities to combine third stage trials (on hundreds of human samples usually spread over 1-3 years) and stage 4 trials (usually done on thousands of human samples over 1-4 years) was accepted by the above authorities and this gave added impetus to Pfizer to race towards completion of the vaccine. It was gradually discovered that to be effective against the virus, the treatment would require two doses of the vaccine spaced three weeks apart.
By end July '20 Pfizer was confident of two vaccine formulations that was ready to go to stage 3 and stage 4. Simultaneously the manufacturing supply chain for the vaccine production in US and Germany proceeded with great haste developing cold supply chains and storage boxes with remotely monitored temperature gauge and GPS monitors. In the meantime Pfizer CEO Albert Bourla (and author of the HBR paper) acting with the CEO of Johnson and Johnson, managed to interact with other pharma CEOs in the race to develop the Covid vaccine to get global acceptance to adhere to rigorous scientific processes and safety standards to develop the vaccine. Everyone agreed that speed was critical but not at the expense of scientific rigour.
By September the manufacturing team was ready with the production line for vaccines. By November as the phase 3 and phase 4 trials were proceeding, only 94 of the 43,500 people who were administered the doses had fallen sick (<0.2%). These 94 people were also from the placebo group, who were administered a placebo instead of the Covid vaccine.
With the efficacy of the vaccine established, by December 8, 2020, UK started using the vaccine on its citizens and by Dec 14, 2020 US too after approval from FDA. In 2021, Pfizer is planning to produce 2 billion does of the vaccine. In the history of humanity it is for the first time than an anti viral vaccine, instead of the usual development time span of 8-10 years, is getting developed in a span of eight months. Pfizer took a calculated risk of setting up the production lines for its vaccine even months before it was fully accepted by the regulatory authorities. If the tests were not satisfactory, the production facilities would have to be discarded, resulting in great losses for Pfizer. But nothing like that happened.
The lessons learned by Pfizer from this accelerated vaccine development with global collaboration has been multiple.
- Team effort between Pfizer, BioNTech and their supply chain partners
- Purpose first, mission was important, not profits. By keeping the societal good as the priority, the objective was very clear and focused.
- Moon shot challenges with the right purpose are always galvanising and more often than not, tend to hit it big, always keep aims high ..
- encourage out of the box thinking for the team members, do something different from what people have been doing over the years
- Isolating the scientists from financial concerns and excessive bureaucracy to help them to concentrate on the work and develop the vaccine at an accelerated pace
- embrace cooperation at the beginning itself. Though the contracts and deals were finalised only in Dec '20, confidential info between Pfizer and BioNTech was shared as early as March '20.
As of Feb March '21, seven vaccines have been rolled out across the world.(click here) Each of the company would also have a similar story to tell the world of their initial vaccine development challenges and how they overcame it.
Though in the Indian scenario, the Indian companies can produce up to 160 million (16 crore) doses a month, the restrictions on export of certain vaccine components by US companies is stalling the production and this is affecting the deaths in India. (click here). It will also pass and we will meet our targets soon.
George..
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