Posts tagged with "Moderna"

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