“This could be the greatest medical advance in 100 years,” said Pfizer chairman and CEO Dr. Albert Bourla of his company’s blockbuster announcement that its COVID-19 vaccine is showing a 90 per cent efficacy. The announcement has made headlines around the world and has sent stock markets soaring in optimism.
To be clear, what 90 per cent efficacy means is that out of the nearly 44,000 people of diverse backgrounds not previously exposed to the disease enrolled in Phase 3 of the study when Pfizer looked at the infected and non-infected patients, 90 per cent of those infected were shown to have received the placebo, while only 10 per cent of the infected had received the actual vaccine. Thus, 90 per cent efficacy.
This is great news because scientists have long indicated that a vaccine with a 50 per cent efficacy would go a long way to controlling the spread of the pandemic.
It is also of note the diverse background of the study subjects as dark-colored skin people are more propense to be affected by symptomatic COVID-19 than light-skinned people due to a difference in the way the body absorbs sunlight and manufactures Vitamin D, a key secosteroid molecule responsible for regulating the body’s immune system. This is important because much of COVID’s adverse effects on the body are due to an immune overreaction.
Before you throw away your mask and jump for joy in a large crowd, however, it is important to look at the details:
According to Pfizer’s own press release, results are interim results of only 94 cases. Final analysis of clinical trials will need 164 confirmed cases in order to properly compare the vaccine along pre-established mile-markers in vaccine development.
Those results are marked at seven days after the second dose, meaning that a vaccine and boost are necessary to achieve protection. The 2-dose process will need 28 days to be effective.
None of these internal Pfizer data has yet been reviewed outside the company. The company will be providing that data to the US Food and Drug Administration
As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.
Because of all the politics injected into President Trump’s Warp Speed project, there has been plenty of doubt about the safety of any purported vaccines, and the media have been skeptical about early reports from potential vaccine developers whose early reports have only served to boost stock prices at a stage too early to have any significant meaning.
This announcement is being received with greater seriousness because Pfizer is not part of the Warp Speed project and because it is data is coming from Pfizer bur from an external, independent Data Monitoring Committee (DMC), a group of experts that monitors accumulating data for efficacy and patient safety to ensure the scientific integrity of a clinical trial.
“The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide,” said Pfizer in its release.
In the joint statement issued simultaneously in New York and Germany Monday, Pfizer and BioNTech SE, Prof. Ugur Sahin, BioNTech co-founder and CEO said, “The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science, and a global collaborative effort.”
The statement noted that plans are for “submission for Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.”
The caveats are many, including “the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities,” concludes the release.
But the development is indeed the most encouraging of all the vaccines under development and clinical studies
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks,” said Burla.
BioNTech is a next-gen immunotherapy company specialising in the rapid development of novel biopharmaceuticals through the use of high-power computers in discovery efforts of therapeutic drug platforms.
The companies said they will submit data from its full Phase 3 trial for scientific peer-review and publication.
Still to be answered is how long will the vaccine last. There has been a steady stream of reported cases of people who lose immunity after a few months and are reinfected.
“Infections anywhere in the world are infections everywhere,” said on CNN its chief medical correspondent Dr. Sanjay Gupta.
The distribution of the vaccine will require on the largest vaccine systems ever, explained Gupta, with refrigerated storage area spread tragically around the world.
Pfizer said, if successful, it is projecting a global production of up to 50 million doses in 2020 and up to 1.3 billion doses by end of next year. That is only 650 million people, likely not a number high enough for herd immunity, as it amounts to less than 10 per cent of the projected 50%+ needed across the population.
“Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose,” said Pfizer.
