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Pfizer bolsters COVID-19 antiviral manufacturing capacity

Although Pfizer (NYSE:PFE) has yet to receive emergency use authorization for its Paxlovid COVID-19 therapy, it plans to manufacture 80 million courses of the drug by the end of 2022. Pfizer had initially planned on making 50 million courses of Paxlovid (PF-07321332/ritonavir) in the same time frame.

An interim analysis of the Phase 2/3 EPIC-HR study found the drug to be 89% effective at reducing hospitalization or death. Pfizer announced the launch of a Phase 1 study of PF-07321332 in March.

Pfizer has inked a $5.29 billion Paxlovid deal with the U.S. government.

One course of oral Paxlovid therapy would consist of two daily 150-mg doses for five days.

Meanwhile, molnupiravir, the antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, has lost some of its luster. New data suggests the drug led to an absolute risk reduction against hospitalization or death of 3% compared to placebo. Furthermore, the drug led to a relative risk reduction of…

J&J joins Moderna and Pfizer in researching Omicron variant

Johnson & Johnson (NYSE:JNJ) has announced that it is collaborating with academic institutions internationally to gauge the effectiveness of its COVID-19 vaccine against Omicron and other SARS-CoV-2 variants.

In particular, J&J said it is conducting research on blood serum from clinical trial volunteers who have received single or multiple doses of its COVID-19 vaccine.

The company also vowed to design and develop an Omicron-specific variant vaccine if necessary.

“We remain confident in the robust humoral and cell-mediated immune responses elicited by the Johnson & Johnson COVID-19 vaccine demonstrated by the durability and breadth of protection against variants to date in clinical studies,” said Dr. Mathai Mammen, global head, Janssen Research & Development, in a press release. “Building on our long-term collaboration with scientists on the ground in South Africa and the ongoing real-world effectiveness studies being conducted with the J…

Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines.

The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein.

“I don’t think the result would be the vaccines don’t protect,” Pfizer CEO Dr. Albert Bourla told CNBC. It is possible, however, that the vaccines could offer less protection against Omicron than other variants such as Delta.

Get the full story from our sister site, Drug Discovery & Development.

Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines.

The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein, which

“I don’t think the result would be the vaccines don’t protect,” Pfizer CEO Dr. Albert Bourla told CNBC. It is possible, however, that the vaccines could offer less protection against Omicron than other variants such as Delta.

“Given the large number of mutations, it is highly possible that the efficacy of the vaccine – all of them — is going down,” Stéphane Bancel, Moderna CEO, told CNBC.

If they decide it is necessary, Pfizer and its German partner BioNTech (NSDQ:BNTX) could develop a new vaccine based on Omicron in under 100 days.

Moderna has similar plans.

On November …

Pfizer says employee stole confidential COVID-19 vaccine documents

Pfizer (NYSE:PFE) accused a former employee Chun Xiao (Sherry) Li of uploading 12,000 documents from a company-issued laptop to a personal Google Drive account and various personal devices.

In a complaint filed in the U.S. District Court for the Southern District of California, Pfizer also accuses Li of misleading the company about what she did with the files she reportedly took, which included sensitive intellectual property.

The alleged stolen documents pertain to “numerous Pfizer vaccines, drugs, and other innovations,” including its COVID-19 vaccine and avelumab and elranatamab monoclonal antibodies.

The company jointly developed the COVID-19 vaccine with BioNTech. Pfizer jointly developed avelumab (Bavencio) with Merck KGaA, Darmstadt, Germany. The drug won FDA approval in 2020.

The bispecific monoclonal antibody elranatamab remains in the clinic.

The lawsuit notes that Pfizer…

Pfizer-BioNTech COVID-19 vaccine 100% effective in adolescents 12 to 15

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose.

The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In addition, clinical trial investigators reported no serious safety concerns in participants in the six months following receipt of the second dose.

Data from 2,228 individuals were included in the analysis.

In the U.S., the Comirnaty vaccine is available under emergency use authorization for adolescents 12 to 15. The FDA approved the vaccine for individuals at least 16 years of age in August. In late October, the companies received emergency use authorization for the vaccine in children 5 to 11.

Pfizer and BioNTech plan on including the recent data in a planned supplemental Biologics License Application (sBLA) t…

ACIP supports COVID-19 boosters for all adults

CDC’s Advisory Committee on Immunization Practices voted unanimously to allow all fully vaccinated adults to receive a COVID-19 booster at least six months after receiving a primary series.

All 11 members of the panel also voted to recommend boosters for adults 50 and older.

Last week, FDA authorized the mRNA vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) boosters for all adults at least six months after completion of a primary series.

Previously, government authorities had recommended boosters for people 65 and older, those who are moderately to severely immunocompromised, and those at high risk of exposure in occupational or residential settings.

Several states aimed to sidestep the federal government’s booster requirements by allowing all fully adults who received an mRNA-based COVID-19 vaccine to obtain a booster, provided at least six months had elapsed before receiving the second vaccine dose.

Guidance is m…

FDA could soon authorize Pfizer-BioNTech boosters for all adults

The FDA reportedly is planning to authorize the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine booster for all adults in the coming days. FDA could make an announcement on the subject as soon as tomorrow, according to The New York Times.

CDC’s Advisory Committee on Immunization Practices (ACIP) plans on discussing the Pfizer-BioNTech booster data on November 19.

A growing number of U.S. states authorized the vaccine boosters for all adults, including California, Colorado, New Mexico, Kansas, Vermont, Kentucky and Maine.

In September, Pfizer asked federal officials to authorize the vaccine booster for all adults. Instead, it received limited authorization for high-risk groups.

To bolster its application for vaccine boosters for all adults, Pfizer included clinical trial data involving 10,000 participants who received a booster dose.

The news comes as U.S. COVID-19 cases have risen 18% in the past 14 days after having fallen steadily…

Pfizer to make COVID-19 pill available in low- and middle-income nations

In late October, Merck (NYSE:MRK) and its partner Ridgeback Biotherapeutics agreed to make the COVID-19 antiviral molnupiravir available in the developing world.

Now, Pfizer (NYSE:PFE) is taking a similar approach for its investigational antiviral cocktail Paxlovid, which contains PF-07321332 and ritonavir.

Pfizer, like Merck, struck an agreement with the Medicines Patent Pool (MPP) related to Paxlovid.

MPP’s mission is to expand low- and middle-income countries’ access to vital medicines. The United Nations supports the organization.

Pfizer announced earlier this month that Paxlovid was 89% effective in reducing the risk of hospitalization or death in an interim analysis of the Phase 2/3 EPIC-HR trial.

The collaboration with MPP will enable generic drug makers internationally with sub-licenses to produce Paxlovid for use in 95 countries, which comprise more than half of the world’s population.

“This license is so important because, …

TIME recognizes Abbott among this year’s 100 best inventions

The BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]

Abbott (NYSE:ABT) was among a series of medtech companies to receive recognition from TIME in its list of 2021’s best inventions.

The list of the year’s top inventions included Abbott’s innovations twice, with a nod to its NeuroSphere Virtual Clinic and its at-home COVID-19 testing offerings.

NeuroSphere Virtual Clinic allows physicians to speak to patients over a video app and to remotely adjust Abbott’s implanted neuromodulation devices. The platform won FDA approval in March and Time reported that the company plans to expand availability of NeuroSphere Virtual Clinic soon.

Abbott’s BinaxNOW was one of several at-home, over-the-counter COVID-19 tests to receive a mention from Time as the news organization recognized the tests for aiding in efforts to prevent the spread of the virus.

In a post on LinkedI…

California and Colorado to allow COVID-19 boosters for all adults

Flag images courtesy of Wikipedia.

COVID-19 vaccine booster eligibility has gradually expanded, but a significant portion of adults don’t meet the current criteria set forth by FDA and CDC.

California and Colorado have decided to sidestep the federal government by making all fully vaccinated adults in those states eligible for a booster.

California will require that six months have elapsed in order for recipients of the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) vaccines to receive a third dose. Similarly, recipients of the J&J vaccine must wait at least two months before receiving the second dose of that vaccine. Both requirements mirror federal recommendations except for the provision that all fully vaccinated adults are eligible.

Now facing a significant wave of COVID-19 infections, Colorado is also making boosters available for all fully vaccinated adults.

In an…

White House says nearly one million younger children have received COVID-19 vaccines

Image courtesy of Pexels

In a White House COVID-19 Response Team press briefing today, government officials said that 900,000 children between the ages of 5 and 11 will have received their first COVID-19 vaccine dose by the end of the day.

The federal government authorized shots for that demographic last week.

Jeffrey Zients, counselor to the President, estimated that parents had made some 700,000 additional appointments at local pharmacies.

Jeff Zients at a COVID-19 briefing. Image courtesy of the White House.

At present, only the Comirnaty COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) is available to children 11 and younger.

Zients also observed that vaccinations of unvaccinated individuals had also accelerated recently. The pace is now averaging about 300,000 daily shots.

The federal government has …