Posts tagged with "Pfizer"

Shot heard round the world: FDA gives full approval to Pfizer-BioNTech COVID-19 Vaccine

August 24, 2021

The COVID-19 vaccine from Pfizer  and partner BioNTech received full approval from U.S. regulators on Monday, August 23, which many public health officials and vaccine experts hope will encourage hesitant populations to get the shot, reports The Wall Street Journal.

The Food and Drug Administration’s clearance of the shot for people 16 years and older is the agency’s first full approval of a COVID-19 vaccine. The decision was expected this week, the Journal and other news outlets reported.

The vaccine was first cleared in December by the FDA on an emergency-use basis for people 16 years and older after the drugmakers showed it to be highly effective at preventing symptomatic COVID-19. The two-dose shot, resulting from the fastest vaccine development ever in the West, has since become the most-received COVID-19 vaccine in the United States.

The vaccine was authorized for children as young as 12 years in May. Pfizer plans to request full approval for that group once it has collected and analyzed six months of safety data from clinical-trial subjects, according to the company.

Pfizer—which will market the vaccine under the name Comirnaty—is now permitted to market the vaccine to doctors, providers, and the general public, as it does with other approved products. The FDA is permitted to restrict such communications with emergency authorization.

The vaccine is also eligible for off-label prescriptions, which could include booster doses, according to the FDA.

The FDA, under pressure to give COVID-19 vaccines full approval swiftly, made its decision less than four months after Pfizer began its approval submission. The process of reviewing applications normally takes up to approximately ten months.

The FDA said its review found the vaccine to be safe and effective in preventing COVID-19 as well as severe disease, hospitalization, and death. The most common side effects by clinical trial participants who received the vaccine included fatigue, headache, joint pain, chills and fever.

“We have not lost sight that the COVID-19 public health crisis continues in the U.S.A. and that the public is counting on safe and effective vaccines,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the United States.”

The approval comes as U.S. hospitals are seeing a surge in cases tied to the contagious Delta variant, and as the government weighs when vaccinated adults should receive additional doses (the consensus: eight months after the second shot).

Pfizer already has submitted data to the FDA showing that a third dose of its vaccine boosts the immune system against the original virus and against the Beta and Delta variants to higher levels than the standard two-dose regimen. Pfizer plans to submit a request for booster authorization as an amendment to the full approval.

Of the three authorized vaccines in the United States, only Pfizer had submitted all the required information to the FDA, according to the companies, and analysts expected it to be the first to receive clearance.

Moderna, whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech vaccine, has said it is still completing rolling data submissions. Johnson & Johnsonwhose shot was authorized in February, has said it plans to file for full approval later this year.

Research contact: @WSJ

Taking ‘extraordinary measures,’ White House backs suspending patents on vaccines

May 7, 2021

The Biden Administration came out on Wednesday, May5, in support of waiving intellectual property protections for coronavirus vaccines—thereby, siding with international efforts to bolster production amid concerns about vaccine access in developing nations, The New York Times reports.

Under former President Trump, the United States had been a major holdout at the World Trade Organization over a proposal to suspend some of the world economic body’s intellectual property protections—enabling drugmakers worldwide to gain access to the closely guarded trade secrets of how the vaccines have been made.

However, the Times notes, President Biden had come under increasing pressure to throw his support behind the proposal, drafted by India and South Africa and backed by many congressional Democrats.

Katherine Tai, the United States Trade Representative, announced the Administration’s position on Wednesday afternoon, as the pandemic continued to spiral in India and South America.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in a statement. “The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.”

Support from the White House is not a guarantee that a waiver will be adopted. The European Union has also been standing in the way, and changes to international intellectual property rules require unanimous agreement. Tai said the United States would participate in negotiations at the World Trade Organization over the matter, but that they would “take time given the consensus-based nature of the institution and the complexity of the issues involved.”

Standing against her will be the pharmaceutical industry, which responded angrily to the extraordinary decision. Stephen J. Ubl, the president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), called the announcement “an unprecedented step that will undermine our global response to the pandemic and compromise safety.”

“This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,” he said in a statement, adding that the move would have the effect of “handing over American innovations to countries looking to undermine our leadership in biomedical discovery.”

The pharmaceutical industry has argued that a suspension of patent protections would undermine risk-taking and innovation.

“Who will make the vaccine next time?” Brent Saunders, the former chief executive of Allergan, which is now part of AbbVie, wrote on Twitter.

However, the Times reports, global health activists, who have been pressing for the waiver, praised the Administration’s decision. It is “a truly historic step, which shows that President Biden is committed to being not just an American leader, but a global one,” said Priti Krishtel, an executive director of the Initiative for Medicines, Access & Knowledge (I-MAK).

But the activists said a waiver alone would not increase the world’s vaccine supply. It must be accompanied by a process known as “tech transfer,” in which patent holders supply technical know-how and personnel. Activists also are demanding that Biden use his leverage to ensure that manufacturing is scaled up around the globe, and not just by the pharmaceutical companies that now hold the patents.

“Handing needy countries a recipe book without the ingredients, safeguards and sizable work force needed will not help people waiting for the vaccine,” Dr. Michelle McMurry-Heath, the president and chief executive of the Biotechnology Innovation Organization (BIO), said in a statement. “Handing them the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new Covid variants.”

Shares of the pharmaceutical companies BioNTech, Moderna and Novavax dropped on Wednesday afternoon as news broke of the Biden administration’s decision.

Research contact: @nytimes

Pfizer’s new at-home pill to treat COVID could be available by the end of this year

April 28, 2021

Pfizer’s experimental oral drug to treat COVID-19 at the first sign of illness could be available by the end of the year, CEO Albert Bourla told CNBC on Tuesday, April 27.

In March, the company—which developed the first FDA-authorized COVID-19 vaccine in the United States in cooperation with German drugmaker BioNTech—began an early-stage clinical trial testing a new antiviral therapy for COVID. The drug is part of a class of medicines called protease inhibitors and works by inhibiting an enzyme that the virus needs to replicate in human cells.

Protease inhibitors are used to treat other viral pathogens, such as HIV and hepatitis C.

If clinical trials go well and the Food and Drug Administration approves it, the drug could be distributed nationwide by year-end, Bourla told CNBC’s “Squawk Box.”

Health experts say the drug, taken by mouth, could be a gamechanger because people newly infected with the virus could use it outside of hospitals. Researchers hope the medication will keep the disease from progressing and prevent hospital trips.

In addition to the drug, Pfizer is still testing its vaccine in 6-month to 11-year-old children. Vaccinating children is crucial to ending the pandemic, public health officials and infectious disease experts say.

Earlier this month, the company asked the FDA to expand its vaccine authorization to adolescents ages 12 to 15 after the shot was found to be 100% effective in a study.

Bourla told CNBC on Tuesday he is “very optimistic” that the FDA will approve the use of the shot in adolescents.

Research contact: @CNBC

Johnson & Johnson COVID-19 vaccine pause likely to last only a few days

April 14, 2021

On Tuesday morning, federal officials said they expected the recommended pause in administration of the Johnson & Johnson COVID-19 vaccine to last only a few day—and said it should not impact the United States’ vaccination goals, Roll Call reports.

The Food and Drug Administration and the Centers for Disease Control and Prevention announced early on March 13 that the they were recommending a pause in Johnson & Johnson COVID-19 vaccinations after six female patients out of the 6.8 million Americans who had received the vaccine to date reported the development of a rare type of blood clot six to 13 days after vaccination. The women were between the ages of 18 and 48.

The Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, told reporters on a call that the pause is necessary to educate providers about the type of blood clot caused by the Johnson & Johnson vaccine, called a cerebral venous sinus thrombosis.

Standard blood clot treatment does not work for this type of clot, which, according to Johns Hopkins Medicine, occurs in the brain’s venous sinuses. Such a clot prevents blood from draining out of the brain. As a result, blood cells may break and leak blood into the brain tissues, forming a hemorrhage—and leading tio a life-threatening stroke.

The experts warn that, if the standard course of treatment is followed for a cerebral venous sinus thrombosis, it could cause further harm or even be fatal, Roll Call reports.

Marks said there is no known link to birth control or contraceptives. The only hypothesis health officials mentioned is that the adenovirus vaccine creates an extreme immune reaction in some people that causes platelet clots.

The CDC’s Vaccine Advisory Committee on Immunization Practices is set to meet on Wednesday, March 14, to review these cases and discuss the potential significance.

CDC Principal Deputy Director Anne Schuchat told reporters that anyone who was vaccinated with this one-shot vaccine a month ago or more should not worry. But anyone who received the Johnson & Johnson coronavirus vaccine in the past few weeks should watch for symptoms including severe headaches, leg pain, or abdominal pain that differs from typical post-vaccination symptoms.

Acting FDA Commissioner Janet Woodcock said these reactions are extremely rare and should not deter Americans from getting vaccinated for COVID-19. The pause is due to regular safety monitoring, she said.

“The message to patients who haven’t been vaccinated is to continue to get vaccines that may still be available to them,” Woodcock said.

White House COVID-19 Response Coordinator Jeff Zients told reporters the delay would not have a significant impact on the U.S. vaccination plan. The one-shot vaccines from Johnson & Johnson make up less than 5% of recorded shots in arms to date.

The U.S. has secured enough doses of the COVID-19 vaccines from Moderna and Pfizer to continue vaccinating 3 million people per day, Zients said. States and the federal government plan to work quickly to get anyone scheduled for a Johnson & Johnson vaccine rescheduled for a two-dose shot by Moderna or Pfizer.

The pause will immediately impact the places that receive vaccines directly from the federal government: retail pharmacies, community vaccination clinics, mobile vaccinations units and FEMA-run sites.

The move could shutter some mass vaccination sites. The Federal Emergency Management Agency said it is working with states to find other vaccines.

“FEMA is committed to helping the President’s goal to ensure everyone who wants to be vaccinated can be. In alignment with the Centers for Disease Control and Prevention and Food and Drug Administration’s recommendation to pause the use of the Johnson & Johnson vaccine, effective immediately FEMA will stop administering this vaccine at our pilot Community Vaccination Clinics, as well as via our Mobile Vaccine Units,” said Acting Administrator Bob Fenton in an emailed statement. “We are working with our state partners to determine the path forward and find alternative vaccine options for these sites.”

Georgia, North Carolina, and Colorado have reportedly shut vaccination sites because of adverse events experienced by people receiving the Johnson & Johnson vaccine.

Several states—including Maryland, New York, and Ohio—confirmed Tuesday morning that they would pause administering the vaccine.

Research contact: @rollcall

Pfizer asks FDA to approve ‘not-so-cold storage’ for its vaccine

February 22, 2021

Pfizer announced on February 19 that  it is seeking permission from the Food and Drug Administration to store its COVID-19 vaccine for two weeks at temperatures that still are extremely cold, but that are commonly found in pharmaceutical freezers and refrigerators, CNBC reports.

The vaccine, which was developed with German drugmaker BioNTech, currently needs to be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, according to the FDA.

Pfizer said it submitted new data to the U.S. agency that demonstrates that the vaccine is stable at between minus 13 and minus 5 degrees Fahrenheit, according to CNBC.

If the FDA grants the request, it could simplify logistics for distribution of the vaccine. U.S. federal and state officials are trying to pick up the pace of vaccinations as the virus spreads.

“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the [nation] and around the world,” Pfizer CEO Albert Bourla said in a release. “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”

Medical experts had warned that Pfizer’s vaccine would present logistical challenges because of the need for ultracold temperatures. In December, U.S. officials said they quarantined several thousand doses in California and Alabama after an “anomaly” in the transportation process caused the storage temperature to get too cold, CNBC notes.

The vaccine is shipped in a special thermal container that can be used as temporary storage for up to 30 days , if it is refilled with dry ice every five days. Before mixing with a saline diluent, the vaccine also may be refrigerated for up to five days at standard refrigerator temperature, between 36 degrees and 46 degrees Fahrenheit, according to the company.

By comparison, Moderna’s vaccine needs to be shipped at between minus 13 and minus 5 degrees Fahrenheit. It has said its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for six months at minus 4 degrees Fahrenheit.

Johnson & Johnson’s vaccine, which is expected to be authorized for emergency use by the FDA as early as this month, has said it plans to ship its vaccine at 36 to 46 degrees Fahrenheit.

As additional stability data is obtained, Pfizer said it anticipates the shelf life could be extended, and alternate short-term temperature storage may be considered.

Research contact: @CNBC

 

More than 170 top U.S. business leaders urge Congress to certify Biden’s Electoral College win

January 6, 2021

More than 170 American business leaders signed a letter on January 4 urging Congress to certify the result of the presidential election without delay, Business Insider reports.

Signatories included Goldman Sachs Chairman and CEO David Solomon; Microsoft President Brad Smith;  BlackRock CEO Laurence Fink; Pfizer CEO Albert Bourla; James Zelter, a co-president of Apollo Global Management; and Lyft CEO Logan Green.

Congress is scheduled to certify the result on Wednesday, January 6—thereby confirming President-elect Joe Biden’s Electoral College victory. President Donald Trump has so far refused to acknowledge that he lost the election.

The Partnership for New York City, a nonprofit organization and major business advocacy group, published the letter on Monday. “This presidential election has been decided and it is time for the country to move forward,” the letter said. “President-elect Joe Biden and Vice President-elect Kamala Harris have won the Electoral College and the courts have rejected challenges to the electoral process.”

According to Business Insider, the leaders added that “attempts to thwart or delay this process run counter to the essential tenets of our democracy.”

Biden and Harris deserve respect and bipartisan support as America faces “the worst health and economic crises in modern history,” they said.

The letter said that Congress should certify the electoral vote and that “there should be no further delay in the orderly transfer of power.”

But at least 140 Republican House members are planning to vote against certification, two representatives told CNN last week.

Trump and other Republicans have tried to overturn the result of the election, pushing false claims of voter fraud.

Over the weekend, Trump pleaded with Georgia’s secretary of state in an hourlong phone call to “find” additional votes to overturn Biden’s victory in the state.

Biden won the 2020 presidential election with 306 electoral votes, flipping five states that voted for Trump in 2016.

Research contact: @businessinsider

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