Posts tagged with "BioNTech"

FDA moves closer to clearing Moderna and J&J COVID booster shots this week

October 12, 2021

Millions of Americans will be one step closer to receiving a COVID-19 booster shot this week when a key Food and Drug Administration advisory panel meets Thursday and Friday, October  14 and 15, to debate extra doses of the Moderna and Johnson & Johnson vaccines, reports CNBC.

The FDA’s Vaccines and Related Biological Products Advisory Committee meetings come less than a month after U.S. regulators authorized COVID booster shots of Pfizer and BioNTech’s vaccine to a wide array of Americans, including the elderly, adults with underlying medical conditions; and those who work or live in high-risk settings, like health and grocery workers.

More than 7 million Americans have received a booster dose in the United States as of Saturday, October 9, according to the latest data available from the Centers for Disease Control (CDC).

Members on independent committees by the FDA and CDC and Prevention said at the time they were frustrated that only Pfizer recipients would be eligible to get the extra shots, leaving out millions of Americans who got Moderna or J&J’s shots.

The FDA advisory group is scheduled Thursday to discuss data on the safety and effectiveness of a Moderna booster shot in adults. On Friday, the committee is expected to debate J&J booster shots for adults. The FDA could make a final decision within days of the meetings, handing it off to the CDC and its vaccine advisory committee to make their own decision.

The CDC’s next vaccine advisory meeting is scheduled to take place from October 20 to October 21, when it’s expected to discuss the boosters.

Research contact: @CNBC

Biden to pledge 500 million more Pfizer vaccine doses for poor nations at U.N. COVID Summit

September 23, 2021

President Joe Biden was expected to announce on  Wednesday, September 22 that the United States will purchase 500 million additional doses of the coronavirus vaccine developed by Pfizer  and BioNTech to donate to developing countries, senior administration officials told The Wall Street Journal.

Biden was scheduled to make the announcement at a virtual COVID-19 summit on the sidelines of the United Nations General Assemblybringing the total U.S. commitment to 1.1 billion doses to be shared overseas.

According to the Journal, the decision comes as Biden is seeking to expand America’s role in helping to accelerate global vaccination efforts in low- and lower-middle-income countries that have struggled with access to shots.

The new batch of Pfizer vaccines will be manufactured in the United States and begin shipping out in January, officials said. The donation doubles an earlier U.S. pledge of 500 million Pfizer doses to developing countries by the end of June 2022.

The donated vaccines are being routed through Covax, an international program backed by the World Health Organization and tasked with supplying vaccines to the world’s poorest nations.

Although the United states has so far offered the largest donation total of any country, some international aid groups have called on the Biden Administration and other wealthy nations to do more to help inoculate the global population. Only 2% of people in low-income countries have received a first dose of the vaccine, according to the University of Oxford’s Our World in Data project, prompting some health experts to warn that more lives could be lost to COVID-19 in 2022 than 2021.

The U.S. previously sent more than 110 million doses overseas, most of which were manufactured by Moderna Inc. and Johnson & Johnson, with recipient countries ranging from wealthy allies such as Canada to developing nations like Haiti.

Biden also planned to use Wednesday’s summit to call on other world leaders to help expand global access to the vaccine and take steps to make testing, therapeutics and personal protective equipment more available around the world, officials said. He intended to further urge leaders to help low- and lower-middle-income nations vaccinate at least 70% of their populations by September next year.

Research contact: @WSJ

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 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

 

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