CDC’s ACIP deprioritizes Johnson & Johnson’s COVID-19 vaccine

CDC’s Advisory Committee on Immunization Practices (ACIP) voted 15 to 0 to prioritize the Pfizer-BioNTech and Moderna COVID-19 vaccines over Johnson & Johnson’s.

One of the main reasons for the recommendation is a rare side effect associated with the Johnson & Johnson vaccine that results in low blood clots and blood-platelet levels.

CDC officials revealed that there had been 54 cases of the condition, known as thrombosis with thrombocytopenia syndrome.

FDA temporarily paused the use of the vaccine in April over blood clot concerns.

The J&J vaccine has lagged behind the mRNA-based Pfizer-BioNTech and Moderna vaccines in terms of demand.

To date, U.S. health workers have administered 17 million doses of the Johnson & Johnson vaccine compared to 286 million Pfizer-BioNTech doses and 187 million Moderna doses, according to CDC data.

The J&J vaccine also trails its rivals in terms of vaccine efficacy.

That said…

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Three doses of Pfizer-BioNTech vaccine neutralized Omicron variant in the lab

Pfizer (NYSE:PFE) and BioNTech SE (NSDQ:BNTX) have announced that their vaccine remains effective against the Omicron variant (B.1.1.529 lineage) of SARS-CoV-2 in early lab studies.

Two doses of the vaccine significantly reduced neutralization titers, while three neutralized the variant.

The lab studies showed that three doses of the BNT162b2 vaccine were similar in efficacy against Omicron as two doses were against the wild-type SARS-CoV-2 spike protein.

Pfizer and BioNTech indicated that two doses of the BNT162b2 are likely insufficient to prevent infection from the Omicron variant. However, the companies still expect that two doses of the vaccine will be effective at protecting against severe disease related to the Omicron variant.

Early evidence suggests that Omicron may offer less of a risk of severe disease than the Delta variant, which continues to dominate the U.S.

“Although two doses of the vaccine may still offer protection agains…

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Why global vaccine equity could prolong the COVID-19 pandemic

[Photo by Fusion Medical Animation on Unsplash]

In May, the World Health Assembly set the goal of fully vaccinating 10% of each country’s population by September 30. A number of countries hit the goal, including 15 in Africa, but more than 50 didn’t.

“It’s very concerning,” said Donna Patterson, a fellow at the Wilson Center, in a recent webinar from that organization. Uneven vaccination rates threaten to extend the COVID-19 pandemic’s timelines. Some countries remain far behind the 10% goal. For example, the percentage of fully vaccinated people in Senegal is 5.6%. Burundi’s rate is near 0%. “There are other countries that are higher, mostly in North Africa, including Morocco, but that also varies,” said Patterson, who is also a professor at Delaware State University.

Vaccination rates are also lagging in regions such as the Caribbean, Latin Americ…

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FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron

Acting FDA Commissioner Dr. Janet Woodcock

Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy.

In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests, therapeutics, and vaccines.

“Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends,” Woodcock said.

Discovered in late November in South Africa, the Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. The variant has enough mutations to raise concerns worldwide, even though it is still un…

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UK puts vaccine manufacturing goes up for auction

Image courtesy of VMIC

The U.K. government has put a manufacturing plant up for sale that was instrumental in the country’s plan to battle future pandemics.

According to The Financial Times, the plant, dubbed the Vaccine Manufacturing Innovation Centre (VMIC), had received at least £215 million of public funding since it was launched in 2018.

A handful of companies have placed bids for the 74,000 m2 plant, located in Harwell, approximately 15 miles from Oxford.

The U.K. had planned on using the facility to make vaccines for epidemics, but the COVID-19 pandemic has elevated the role of private industry in vaccine manufacturing.

The country had scheduled to complete work on the Vaccine Manufacturing Innovation Centre in 2023 but moved that date to spring 2022 in an earlier phase of the pandemic.

Created as a nonprofit organization, the Vaccine Manufacturing Innovation Centre (VMIC) …

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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…

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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 …

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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…

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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…

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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…

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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…

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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 …

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