Posts tagged with "Pfizer"

Moderna announces vaccine nearly 95% effective

November 17, 2020

The new vaccine from Cambridge, Massachusetts-based Moderna, the biotechnology company, is 94.5% effective against coronavirus, according to a release from the company on November 16—making it the second vaccine to look promising enough to hit the market soon in America, Yahoo reports in an article picked up from the blog, Eat This, Not That.

Last week, New York City-based Pfizer’s vaccine was found to be more than 90% effective.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Moderna CEO Stephane Bancel said in a statement. “Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters.”

Bancel emphasizes, “This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.”

On hearing the news, Dr. Anthony Fauci, the nation’s top infectious disease doctor commented to CNN, “These are obviously very exciting results …. It’s just as good as it gets—94.5% is truly outstanding.”

Regarding the timetable, Fauci said of the Pfizer vaccine the following, which could also apply to Moderna: “What will happen is that,” after the emergency authorization is approved, “at the end of November, the beginning of December, if that goes through—and again, I don’t want to get ahead of the FDA, if they’re going to dot all the I’s and cross all the T’s—but I believe with the impressive nature of the data that that should go through smoothly, that by the time we get into December, we’ll be able to have doses available for people who are judged to be at the highest priority to get.”

As for logistics, “about getting the supply chain intact with the cold requirements”—the vaccine needs to be shipped at a certain low temperature—”that’s all been anticipated and part of Operation Warp Speed, particularly on the general, Gus Perna, the general from the army who has been responsible for making sure this goes smoothly. We anticipate, although they’re all logistic challenges that it will be done successfully.”

As for who gets these vaccines first, Fauci said: “What we have well-established in this country is that the ultimate decision of the distribution in priority, or it goes with the CDC, their advisory committee on immunization practices, traditionally over the years for other vaccines has been responsible for advising them as to the prioritization of the distribution.”

Regular folks with no underlying conditions might have theirs by April.

Research contact: @Yahoo

Shot to be ‘heard’ around the world: Pfizer says its coronavirus vaccine is more than 90% effective

November 9, 2020

A coronavirus vaccine developed by New York City-based pharmaceutical firm Pfizer is more than 90% effective, according to the first look at data from a late-stage U.S. trial involving nearly 44,000 participants, Politico rerports.

An analysis of 94 trial participants who contracted COVID-19 showed that the vaccine was 94% effective, the company and its partner BioNTech of Germany said in a press release on November 9.

The pair added that they expect to apply to the U.S. Food & Drug Administration (FDA) for an emergency-use authorization before the end of the month, after they have collected sufficient data on the vaccine’s safety.

The better-than-expected result is the first Phase III data from any of the four candidates now in the final stage of testing in the United States.

“I can’t imagine better news on the vaccine front,” Walid Gellad, director for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told Politico.  Not only is it highly effective based on the press release, but there were 90 cases so we don’t have to deal with the skeptics about interim analyses, and there appeared to be no safety signals.”

Others noted that the information Pfizer had released was promising but still incomplete. “We should remain a little cautious, said Michael Head, a senior research fellow in Global Health at the University of Southampton in the U.K. “The provisional findings are made available in a press release, and the study is ongoing.”

President Donald Trump, who pushed unsuccessfully for a vaccine by Election Day, cheered the Pfizer result. “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he wrote on Twitter.

Although Ivanka Trump tried to link the new vaccine to the Administration’s Operation Warp Speed, a top scientist for Pfizer told the New York Times that her company had not partnered with the Trump administration’s program meant to speed vaccine development.

President-elect Joe Biden issued a statement congratulating “the brilliant women and men who helped produce this breakthrough,” but he cautioned that “the end of the battle against COVID-19 is still months away.”

Even if a shot is authorized by late November, it will take many months before vaccination is widespread, Biden noted. “Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year,” he said.

Research contact: @politico

A shot in the dark? Drug companies issue rare joint pledge on vaccine safety

September 9, 2020

On September 7, nine pharmaceutical companies issued a rare joint pledge—intended to reassure the American public about the safety and efficacy of the coronavirus vaccines that currently are under development.

The statement from the top drug companies working on COVID-19 vaccines—including Pfizer, AstraZeneca, and Moderna—comes amid fears that President Donald Trump will continue to place pressure on the industry to speed up the vaccine approval process without proper oversight, and doubts among the public about taking a vaccine, The Hill reports.

The joint pledge states that the companies will not seek Food and Drug Administration (FDA) approval for their vaccines until a rigorous phase 3 clinical trial shows that it is safe and that it works. 

The companies pledged they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”

The companies said they would “always make the safety and well-being of vaccinated individuals our top priority.”

Highlighting the fears of political interference, Trump on Monday floated the idea of having a vaccine before Election Day on November 3. “We’re going to have a vaccine very soon. Maybe even before a very special date. You know what date I’m talking about,” he said at a news conference.

Trump has put pressure on the FDA before, saying that the “deep state” at the agency was throwing up roadblocks before the agency issued an emergency authorization for a coronavirus treatment known as convalescent plasma.

According to The Hill, FDA Commissioner Stephen Hahn also has offered reassurances that his agency will base vaccine decisions only on science and not on politics.

But the statement from the pharmaceutical companies is an illustration of how deep the fears are about politicization of the process and the need for companies to try make their own reassurance about science guiding the process.

An NPR-PBS NewsHour-Marist poll last month found that a significant portion of the public (35%) did not intend to receive a coronavirus vaccine.

Research contact: @thehill