Pfizer, in partnership with German company BioNTech, said today that they have developed an effective COVID-19 vaccine and expect the U.S government to authorize its emergency use this month after the drugmaker released data showing no serious safety concerns.
Albert Bourla, Pfizer's chairman and CEO, said in a statement that the vaccine candidate was found to be more than 90% effective in preventing the coronavirus in participants without prior infection. The mRNA-based vaccine has reportedly prevented infection in the majority of people who receive it.
"It's important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone," said Bourla. "More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study."
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WHAT'S THE IMPACT?
The timeline of when a vaccine could become widely available is in question.
Pfizer estimates a timeline of a median of two months of safety data following the second and final dose of the vaccine candidate – which is required by FDA's guidance for potential Emergency Use Authorization. Pfizer expects to have the requisite data for the EUA available by the third week of November.
Pfizer said it is on track to ask health regulators for permission to sell the shot before the end of this month, if pending data indicate the vaccine is safe, according to The Wall Street Journal. U.S. health regulators have indicated they will take some time to conduct their review. Then it will take months for the companies to make enough doses for the general population, the report said.
The company is also generating data to show that the vaccine can be consistently manufactured to meet quality standards.
"Efficacy, safety and consistent manufacturing are the three requirements that are needed before we are able to file for authorization," said Bourla.
According to STAT News, the vaccine does come with side effects, including aches and fevers, though company reps said this is comparable to standard adult vaccines, albeit worse than Pfizer's pneumonia and flu shots.
Pfizer said up to 50 million doses could be available globally by the end of the year, with that number climbing to 1.3 billion in 2021, though there are anticipated distribution challenges, stemming from the fact that the vaccine must be stored at very cold temperatures. That makes delivery to many places at once a logistical challenge.
Nor is that the only potential downside. The announcement was met with some pushback from industry insiders, including Michael Carome, director of Public Citizen's Health Research Group, who said the "preliminary and incomplete" clinical trial represents "bad science."
"Until the trial results are independently reviewed and scrutinized by staff at the U.S. Food and Drug Administration and the independent experts on the agency's Vaccines and Related Biological Products Advisory Committee, enthusiasm for the apparently promising interim results announced by Pfizer and BioNTech must be tempered," said Carome. "Crucial information absent from the companies' announcement is any evidence that the vaccine prevents serious COVID-19 cases or reduces hospitalizations and deaths due to the disease.
"More importantly, critical safety data from the phase 3 trial of the Pfizer and BioNTech vaccine is not yet available. In order to ensure public confidence in this vaccine or any other COVID-19 vaccine being tested, the FDA must wait for sufficient long-term safety monitoring of subjects to be completed before approving such vaccines."
mRNA technology uses genetic material to prompt the human body to create a protein from the virus, which the immune system then recognizes and learns to attack. No mRNA product has ever been reviewed by regulators, according to STAT.
According to Reuters, Pfizer will continue the trial until there are 164 COVID-19 cases among participants. While the data has yet to be peer-reviewed or published in a medical journal, the company said it would do so once it has results from the entire trial.
THE LARGER TREND
In September, the Centers for Disease Control and Prevention said it was distributing $200 million to help jurisdictions prepare for an eventual COVID-19 vaccine. The money will be sent through CDC's existing immunization cooperative agreement and will help support 64 jurisdictions as they plan and implement COVID-19 vaccination services, according to the Department of Health and Human Services. The amount each jurisdiction receives is determined based on the size of the population.
In late October, the Centers for Medicare and Medicaid Services mandated that all Americans have access to a coronavirus vaccine when it becomes available at no out-of-pocket cost. The agency's interim final rule makes clear that private insurers must cover the vaccine at no charge to beneficiaries. Insurers are prohibited from charging for administration costs of the vaccine, CMS said.
Medicare Advantage beneficiaries also pay nothing for COVID-19 vaccines and their copayment/coinsurance and deductible are waived.
Politics and the efficacy of a potential vaccine have an influence over the level of trust the American public is willing to give any new treatments, according to Cornell research. If an initial COVID-19 vaccine is about as effective as a flu shot, uptake by the American public may fall far short of the 70% level needed to achieve herd immunity.
Herd immunity is achievable through natural spread or through a vaccine, though this sometimes requires "reapplication," as with an annual flu shot.
In surveys of nearly 2,000 American adults, barely half said they would be willing to take a hypothetical vaccine with an efficacy of 50% – the U.S. Food and Drug Administration's minimum threshold for a COVID-19 vaccine, and comparable to flu vaccines.
Vaccine acceptance increased by 10 percentage points, to 61%, if its theoretical effectiveness increased to 90%, making efficacy among the most important factors in Americans' willingness to adopt a COVID-19 vaccine.