Consumer Advocates Warn Pfizer Data Is Incomplete — Vaccine Is Still Months Away

As the United States shatters global records for COVID-19 infections, news on Monday of early trial data suggesting that a potential vaccine for the virus is 90 percent effective provided a brief sense of relief.

However, scientists and pharmaceutical watchdogs cautioned that the preliminary data released by Pfizer, the multinational giant behind the vaccine, is merely a snapshot of a clinical trial and does not show whether the vaccine is safe and would effectively prevent hospitalizations and deaths among the elderly and medically vulnerable.

Pfizer released the preliminary trial data into a highly charged political atmosphere, with the number of new COVID-19 infections surging as the nation contends with the fallout of an election shaped in so many ways by the pandemic.

“The release of preliminary and incomplete clinical trial data by press release to the public is bad science,” said Michael Carome, director of Public Citizen’s Health Research Group, in a statement on Monday.

Meanwhile, COVID-19 cases in the United States hit 10 million this week, more than any other country in the world. Fueled by outbreaks in the upper Midwest and Great Lakes area that have grown for weeks, the U.S. reported about a million new cases over the past 10 days, reflecting daily counts exceeding 100,000, far more than any other nation. Hospitalizations have doubled since mid-September, with a slow but steady uptick in deaths following, according to pandemic trackers at The New York Times.

Contrasting Trump, Biden Urges Continued Mask-Wearing

Pfizer’s announcement was quickly wrapped up in politics as people close to President Trump attempted to erroneously give his administration credit for the vaccine, leading Pfizer to clarify that the company did not receive government funding for development. Donald Trump Jr., the president’s son, suggested without evidence that there was a conspiracy to keep the trial data under wraps until after the election. Trump Jr. insisted that “Big Pharma hates Trump” for working to lower prescription drug prices, which President Trump repeatedly promised but largely failed to do.

President-Elect Joe Biden implored Americans on Monday to continue wearing masks through the winter as a widely distributed vaccine is likely still months away, despite the promising news from Pfizer. Biden announced a pandemic task force made up of public health experts and former federal health officials as part of his transition team, which is already crafting COVID-19 policies ahead of Biden’s inauguration on January 20.

“The head of the CDC warned this fall that, for the foreseeable future, a mask remains the most potent weapon we have against the virus,” Biden said. “Today’s news does not change that urgent reality.”

While Biden did not mention the sitting president by name, he asked Americans to put aside partisan divisions over mask-wearing. Throughout his reelection campaign and the pandemic, Trump repeatedly, and with little evidence, assured his followers that effective COVID-19 treatments and vaccines would soon be widely available while flouting mask-wearing and social-distancing rules. Trump and others at the White House tested positive for coronavirus last month and received medical treatment.

In September, Trump said on television that he would be “getting” a vaccine “in a matter of weeks,” and predicted a vaccine would be available to the public before November, a claim that clearly contradicted statements by various health officials at the time.

A Widely Available Vaccine Is Likely Still Months Away

Pfizer made its vaccine announcement based on the analysis of 94 trial participants with confirmed COVID-19 infections in a study that enrolled 43,500, according to a press release. The vaccine clinical trial continues and will eventually conclude with a final analysis of 164 confirmed cases, and data on safety and efficacy are still being collected, the company said. Pfizer partnered with the German biotech firm BioNTech to develop the vaccine.

Carome said “enthusiasm” for Pfizer’s vaccine should be “tempered” until the clinical trial is reviewed by the Food and Drug Administration and Pfizer makes more data on safety and efficacy available.

“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,” Carome said. “More importantly, critical safety data from the phase 3 trial of the Pfizer and BioNTech vaccine is not yet available.”

Still, the preliminary data on the vaccine’s efficacy generated plenty of excitement. The stock market jumped — along with stock prices for Pfizer and BioNTech. Trump boasted about the stock market and the vaccine on Twitter, stopping short of taking credit for the vaccine on behalf of his administration, as sitting Vice President Mike Pence did in a tweet that was immediately questioned by experts and journalists.

Pfizer later clarified that, while the company has made a “purchase agreement” with the U.S. government as a potential vaccine supplier, it has not received any public funding from the Trump administration’s multibillion dollar private-public effort to develop and distribute a vaccine. While the Trump administration could potentially take credit for distributing Pfizer’s vaccine if it’s approved before Biden takes office — a big “if” — Trump and Pence cannot truthfully take credit for the development of this particular vaccine, only for providing an incentive by offering to buy the final product: a policy no-brainer.

However, in 2016 researchers at the National Institutes of Health developed a method for freezing coronavirus “spike” proteins that is being used by Pfizer and other drug makers to create the first generation of COVID-19 vaccines, according to Public Citizen. While this technology preceded the Trump administration’s private-public partnerships to rapidly develop of a COVID-19 vaccine, it is just the latest example of private companies using taxpayer-funded research and technology to develop crucial medicines that can be sold to taxpayers for a profit, undercutting Pfizer’s claim that is received no government support.

Anthony Fauci, the government’s lead infectious disease expert who is regularly attacked by Trump, said the preliminary results of the vaccine trial showing 90 percent effectiveness are “just extraordinary.” Fauci and other scientists have warned for months that an initial vaccine may only be 50 or 60 percent effective and could require multiple shots administered to each patient.

“It’s going to have a major impact on everything we do with respect to COVID,” Fauci told The Associated Press.

The vaccine is one of dozens currently in development in the U.S. and globally, including 11 in late-stage testing. Many questions remain. The data released on Monday comes from fewer than 100 participants, and Pfizer released few details about how its vaccine trial is structured, including how many participants received the vaccine and how many received a placebo.

Pfizer and BioNTech still must show that the vaccine is effective in dozens of additional study participants and track any side effects that may occur over the course of weeks. If the vaccine receives an emergency approval before the end of the year, Pfizer expects to produce enough doses to treat only 25 million people before 2021, when production would increase. Experts have repeatedly cautioned that, when a vaccine is approved, it will likely be rationed at least initially, with access prioritized for health care workers and the medically vulnerable.

On Monday, Biden said widely distributing a vaccine “free of charge” is the goal of his administration, but that could be months down the line. Biden said his administration would also work to distribute more COVID-19 tests, support widespread contact tracing and produce more personal protective equipment for health care workers. Biden said addressing racial disparities that cause higher rates of infection in communities of color is a priority for his pandemic task force, and activists are expected to hold Biden accountable to this pledge. In the meantime, everyone should wear a mask in public.

“Please, I implore you, wear a mask,” Biden said. “Do it for yourself, do it for your neighbor.”

This story has been updated.