RIO DE JANEIRO, BRAZIL – An announcement by Pfizer Monday that interim reports of its COVID-19 vaccine show a 90 percent efficacy made headlines around the world in a welcome break from grim news about the progress of the disease. The news boosted the DOW to a gain of nearly 1500 points by mid-morning Monday, November 9th. Indeed it is a remarkable level of effectiveness.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Pfizer Chairman and CEO Dr. Albert Bourla. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity, and economies struggling to reopen.”
To be clear, what 90 percent efficacy means is that out of the people enrolled in Phase 3 of the study, all of whom had not previously had the disease, 90 percent of those infected were shown to have received a placebo during the study, while only 10 percent of those infected had received the actual vaccine. Thus, 90 percent efficacy.
This is great news because scientists have long indicated that a vaccine with 50 percent efficacy would go a long way to controlling the spread of the pandemic.
Also of note is the diverse background of the study subjects, as dark-skinned people are more likely 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 only, and refer to only 94 cases. Final analysis of clinical trials will need 164 confirmed cases in order to properly compare the vaccine along preestablished mile-markers in vaccine development.
Those results are marked at 7 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 U.S. 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 not from Pfizer but 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 Authorization (EUA) to the U.S. 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 specializing 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 one of the largest vaccine systems ever, explained Gupta, with refrigerated storage areas spread strategically 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 the 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% of the projected 50%+ needed across the population.
Brazil in Talks to buy Vaccine
The Brazilian federal government is in talks with Pfizer in Brazil to buy its experimental COVID-19 vaccine for inclusion in its national vaccination program, a spokesman for the company said on Monday.
Brazil’s Ministry of Health, in response to a Reuters request for comment, said it was considering all potential vaccines that are currently in late-stage trials, including Pfizer’s.
The vaccine is undergoing late-stage tests in Brazil involving 3,100 volunteers in Sao Paulo and Bahia states, and would be imported from Pfizer’s factories in the United States and Europe, the spokesman said, giving no further details.
The company said on Monday its vaccine is more than 90% effective based on initial trial results.