COVID-19 vaccine Archives - Page 7 of 38

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, 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…

Senator Markey pushes U.S. to develop universal COVID-19 vaccine

Image from www.edmarkey.com

Senator Edward J. Markey (D-Mass.) has sent a letter to the National Institute of Allergy and Infectious Disease (NIAID) asking for a status update regarding ongoing research to develop a universal COVID-19 vaccine.

NIAID had awarded $36.3 million to academic institutions to conduct research that will help develop a coronavirus vaccine that protects against multiple types of coronaviruses.

Coronavirus outbreaks have resulted in three outbreaks in the past two decades. First, there was severe acute respiratory syndrome (SARS) from 2002 to 2004. Then, Middle East respiratory syndrome (MERS) appeared in 2012 and SARS-CoV-2 seven years later.

“Had a universal coronavirus vaccine existed at the onset of the pandemic, hundreds of thousands of American lives could have been saved,” wrote Senator Markey in a press release. “And we remain at risk of variants that have the pot…

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…

OSHA suspends enforcement of COVID-19 vaccine mandate

Image courtesy of Pixabay.

The Biden administration will not proceed with enforcing its vaccine mandate for businesses with at least 100 employees given a recent decision by the U.S. Court of Appeals for the Fifth Circuit.

The administration had planned on putting the Occupational Safety and Health Administration (OSHA) in charge of administering the COVID-19 vaccine mandate. While a statement on the OSHA website proclaims that it “remains confident in its authority to protect workers in emergencies,” the agency agreed it would suspend enforcement of the emergency temporary standard (ETS) that would have required many U.S. employees to be fully vaccinated or face regular testing. However, OSHA could change course in the event of a further court order.

The U.S. Court of Appeals for the Sixth Circuit will hear the challenge to the OSHA-specific vaccine mandate.

For the time being, however, OSHA h…

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…

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

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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…

J&J COVID-19 vaccine to find use in conflict zones

Johnson & Johnson (NYSE:JNJ) has reached an agreement with the U.S. government and the public–private health partnership Gavi to distribute the Ad26.COV2.S vaccine to conflict zones or humanitarian settings.

New Brunswick, NJ–based Johnson & Johnson anticipates deliveries in such areas in the coming days.

“We believe our single-shot COVID-19 vaccine has a critical role to play in conflict zones and other humanitarian settings that can’t be reached by government vaccination campaigns, and we are proud to be part of this effort to protect the world’s most vulnerable people,” said Dr. Paul Stoffels, J&J’s vice chairman of the executive committee and chief scientific officer, in a press release.

To facilitate deliveries to such hard-to-reach areas, Gavi established the concept of a COVAX Humanitarian Buffer earlier this year. Governments and humanitarian agencies can apply for authorization for the distinction from Gavi.

The Inter-Agen…

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

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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 …

Pfizer and BioNTech file for FDA authorization of COVID-19 vaccine boosters for all adults

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have filed paperwork with FDA to authorize their COVID-19 vaccine for all adults 18 and older.

The two companies had filed a supplemental Biologics License Application for a booster dose of the COVID-19 vaccine in adults at least 16 years old.

FDA did not accept the supplemental Biologics License Application, however. Instead, FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine in September to allow individuals with an elevated risk to receive a single booster dose. The EUA required that eligible individuals receive a booster dose at least six months after completing the primary series.

Earlier, an advisory committee had decided there was insufficient evidence to warrant approval for all adults. In particular, the committee expressed concerns about the rare risk of myocarditis in some younger vaccine recipients.

Instead, the U.S. authorized Pfizer booster doses in October for adults 6…