Posts tagged with "Moderna"

Biden to donate 500 million doses of Pfizer vaccine worldwide over a year

June 11, 2021

In a speech set to be delivered on Thursday, June 10, on the eve G7 Cornwall Summit in the United Kingdom, President Joe Biden plans to  outline plans for the United States to donate 500 million Pfizer-BioNTech vaccine doses to about 100 nations worldwide over the next year—in addition to the 80 million doses he already has pledged will be delivered by the end of this month.

According to a report by The New York Times, in making the announcement, the president will challenge his fellow G-7 leaders— from the United Kingdom, Canada, France, Germany, Italy, and Japan—to step up vaccine distribution in their own nations and in others in order to beat the COVID-19 pandemic.

The White House reached the deal just in time for Biden’s eight-day European trip, which offers his first opportunity to reassert the United States as a world leader and restore relations that were badly frayed by former President Donald Trump.

“We have to end COVID-19, not just at home, which we’re doing, but everywhere,” Biden told American troops after landing at R.A.F. Mildenhall in Suffolk, England, on June 9. “There’s no wall high enough to keep us safe from this pandemic or the next biological threat we face, and there will be others. It requires coordinated multilateral action.”

People familiar with the Pfizer deal said the United States would pay for the doses at a “not-for-profit” price. The first 200 million doses will be distributed by the end of this year, followed by 300 million by next June, they said. The doses will be distributed through COVAX, the international vaccine-sharing initiative.

Biden is in Europe for a week to attend the NATO and Group of 7 summits and to meet with President Vladimir Putin of Russia in Geneva. In a statement on Wednesday, Jeffrey Zients, the White House official in charge of devising a global vaccination strategy, said Biden would “rally the world’s democracies around solving this crisis globally, with America leading the way to create the arsenal of vaccines that will be critical in our global fight against Covid-19.”

According to the Times, the White House is trying to spotlight its success in fighting the pandemic — particularly its vaccination campaign — and use that success as a diplomatic tool, especially as China and Russia seek to do the same. Mr. Biden has been insistent that, unlike China and Russia, which have been sharing their vaccines with dozens of countries, the United States will not seek to extract promises from countries receiving American-made vaccines.

The 500 million doses still fall far short of the 11 billion the World Health Organization estimates are needed to vaccinate the world, but significantly exceed what the United States has committed to share so far. Other nations have been pleading with the United States to give up some of its abundant vaccine supplies. Less than 1% of people are fully vaccinated in a number of African countries, compared with 42% in the United States and the United Kingdom.

Advocates for global health welcomed the news, but reiterated their stance that it is not enough for the United States to simply give vaccine away. They say the Biden Administration must create the conditions for other countries to manufacture vaccines on their own, including transferring technology to make the doses.

“The world needs urgent new manufacturing to produce billions more doses within a year, not just commitments to buy the planned inadequate supply,” Peter Maybarduk, the director of Public Citizen’s Access to Medicines program, said in a statement. He added, “We have yet to see a plan from the U.S. government or the G7 of the needed ambition or urgency to make billions more doses and end the pandemic.”

The deal with Pfizer has the potential to open the door to similar agreements with other vaccine manufacturers, including Moderna, whose vaccine was developed with American tax dollars—unlike Pfizer’s. In addition, the Biden administration has brokered a deal in which Merck will help produce Johnson & Johnson’s vaccine, and those doses might be available for overseas use.

The United States has already contracted to buy 300 million doses of the Pfizer-BioNTech vaccine, which requires two shots, for distribution in the United States; the 500 million doses are in addition to that, according to people familiar with the deal.

Research contact: @nytimes

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

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

 

J&J vaccine provides strong shield against acute COVID-19, prevents hospitalizations

February 1, 2021

Johnson & Johnson’s one-shot vaccine has generated strong protection against acute COVID-19 in a large, late-stage trial—raising hopes that it can rapidly reshape a stumbling immunization campaign, Bloomberg reports.

In a study of more than 43,000 people, the vaccine prevented 66% of moderate to severe cases of COVID-19, according to a company statement released on Friday, January 29.

And it was particularly effective at stopping severe disease—preventing 85% of severe infections and 100% of hospitalizations and deaths.

“If you can prevent severe disease in a high percentage of individuals, that will alleviate so much of the stress and human suffering” of the pandemic, said Anthony Faucidirector of the National Institute of Allelrgy and Infectious Diseases (NIAID) and the top U.S. infectious-disease official—at a briefing on the results with company and government officials.

Based on the result, J&J plans to file with the U.S. Food and Drug Administration for an emergency-use authorization next week. The drug giant’s top scientist said this month he expects a clearance in March, and that it would have product ready to ship then.

The company didn’t specify how much of the vaccine would be available immediately, although it reaffirmed that the United States will receive 100 million doses by the end of June, Bloomberg said.

J&J’s vaccine is different from the messenger RNA-based shots made by Moderna and partners Pfizer and BioNTech SE. It is based on an adenovirus, or cold germ that has been modified to make copies of the coronavirus spike protein—which the pathogen uses to force its way into cells. The altered virus can’t replicate in humans, but it triggers an immune response that prepares the body to defend itself against the coronavirus. J&J uses the same technology in a vaccine to fight Ebola.

J&J’s R&D head said the company’s trial, conducted at the height of the pandemic, had to deal with resistant variants that arose mainly after Moderna’s and Pfizer’s trials were finished. When counting cases, it also focused on somewhat sicker patients, Mammen said.

“If those vaccine programs accrued cases at the same time as us, when viral infections were so much higher, incidents were higher, and variants were all around us, they would have gotten different numbers,” he said. “The fact that we could do this level of efficacy with a single shot—people don’t have to come back for another, and it’s conveniently stored— well that makes this the vaccine of choice.”

At the outset of the pandemic, U.S. government officials said any vaccine showing greater than 50% efficacy would be considered a success.

Research contact: @Bloomberg

Millions of COVID-19 vaccine doses stuck in warehouses until federal orders, Pfizer says

December 21, 2020

Millions of doses of the Pfizer-BioNTech COVID-19 vaccine are languishing in warehouses awaiting shipment instructions from the Trump administration—even as states and first responders are clamoring for them—vaccine manufacturer Pzifer said in a statement on Thursday, December 17.

The startling bottleneck is occurring as America is breaking daily COVID-19 death tolls, The Huffington Post reports. The nation lost more people on Decemeber 16, alone (3,611), than the number of people who died in the terrorist attack on the World Trade Center on 9/11.

Officials in several states said they were told Wednesday that their second shipments of Pfizer-BioNTech’s vaccine next week has been mysteriously reduced, CNN reported. That triggered fears by states that the Trump Administration may be incapable of hitting the target of delivering enough vaccine doses for 20 million injections by the end of the year.

Indeed, Illinois Governjor J.B. Pritzker (D) said Wednesday that federal officials informed states that the expected total shipments of doses nationally over the next two weeks have been cut in half to about 4.3 million doses for each week.

Washington State Governor Jay Inslee (D) tweeted Thursday that the state’s vaccine allocation will be cut by 40% next week and that “no explanation was given.” He called it “disruptive and frustrating.”

States are reportedly already scrambling to cut back and reorganize planned vaccinations.

A source told The Washington Post that Pfizer executives were “baffled” that the Trump administration wasn’t immediately shipping out all of the vaccine.

Pfizer defended itself amid the rising fears about vaccine delivery, noting that it has no production problems—and has doses ready to go.

“This week, we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. government to the locations specified by them,” Pzifer said in its statement. “We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses,” the company added.

A unidentified federal official blamed the delivery change on states’ requests for expedited delivery, leaving less time for inspection and clearing of supplies, the Post reported. “We are sending doses that have been produced, verified and released,” the official said. But that would appear to be contradicted by Pfizer’s statement that millions of doses have been ready for inspection, the newspaper

Pfizer said it has continually kept President Donald Trump’s Operation Warp Speed program, as well as his administration’s Department of Health and Human Services up to date on “every aspect of our production and distribution capabilities,” and officials have “walked the production lines” at company facilities.

Pfizer has a successful and long track record of producing and distributing large volumes of complex vaccines that the world can trust―and we are continuing to extend this track record with our COVID-19 vaccine,” it said.

On top of Pfizer’s 2.9 million doses already shipped, millions of more doses of Moderna’s vaccine are ready to go out next week if they’re approved, which is likely. Pfizer will provide an additional 2 million doses next week, according to HHS Secretary Alex Azar.

The Post characterized the upcoming number as a sharp dropoff from what states were expecting.

Research contact: @HuffPost

Moderna’s vaccine is highly effective, FDA says, clearing way for second vaccine

December 16, 2020

Moderna’s COVID-19 vaccine is 94% effective at preventing symptomatic illness—and appears to prevent the spread of the virus, as well—according to an FDA briefing document released on Tuesday, December 15, NBC News reports. .

The findings set the Moderna vaccine up for emergency use authorization by the FDA—which would double the number of COVID-19 vaccines available, after the first shots of Pfizer-BioNTech’s vaccine were given to healthcare workers nationwide in the USA on Monday.

The high efficacy of the Moderna vaccine was achieved after two doses given 28 days apart. This is about the same level of effectiveness as the Pfizer-BioNTech vaccine.E

But there is also evidence that just one dose of Moderna’s may stop the virus’s spread. A second document published on the FDA website shows asymptomatic infection was reduced by 63% after the first shot.

Still, it is expected that regulators will require two doses of the vaccine for maximum protection, NBC News notes.

A committee independent of the FDA, the Vaccines and Related Biological Products Advisory Committee, will meet Thursday to decide whether to recommend that the agency greenlight the Moderna vaccine. The meeting will largely mirror the one from last Thursday, when the panel of experts ultimately recommended that the FDA authorize Pfizer’s vaccine.

The vaccines from both drugmakers use similar technology.

It is widely anticipated that the Moderna vaccine’s path to approval will be similar to Pfizer’s. Indeed, NBC reports, an authorization could come as soon as Friday. And officials with Operation Warp Speed are already planning for widespread distribution of the Moderna vaccine.

Research contact: @NBCNews

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

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