CDC panel unanimously backs J&J and Moderna vaccine boosters 

CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended the Janssen (NYSE:JNJ) COVID-19 vaccine booster at least two months after the initial dose.

The committee also recommended a booster of the Moderna’s (NSDQ:MRNA) COVID-19 vaccine for people 65 and a handful of other demographics. Also eligible for boosters are individuals at least 18 who are immunocompromised and those who have frequent occupational or institutional exposure to SARS-CoV-2.

The recommendation for the Moderna boosters pertains to the 50-µg dose level, which is half the level used in the primary series.

CDC Director Dr. Rochelle Walensky will now decide whether to accept or alter the ACIP recommendations. For the Pfizer-BioNTech booster, Walensky opted to support boosters for a larger segment of people than the ACIP had recommended.

Walensky is likely to issue a final decision in the coming days.

The CDC advisors also recommended allowing Americans to ch…

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Novartis to continue manufacturing Pfizer/BioNTech vaccine

Novartis (NYSE:NVS) has announced that it has reached an agreement with BioNTech (NSDQ:BNTX) and Pfizer (NYSE:PFE) to produce their popular COVID-19 BNT162b2 vaccine.

The companies reached a new production agreement that will leave Novartis responsible for fill-and-finish operations related to the mRNA-based vaccine from Pfizer and BioNTech.

Under the agreement, Novartis will produce at least 24 million doses of the vaccine in 2022 in its facilities in Ljubljana, Slovenia.

This year, Novartis had an agreement for the fill and finish of more than 50 million doses.

For the agreement pertaining to 2022, Novartis intends to obtain bulk mRNA from BioNTech to fill into vials under sterile conditions. The company will return the vaccine doses to BioNTech for distribution.

In related news, Pfizer recently announced data from a Phase 3 study, which found that a booster dose of its vaccine was 95.6% effective against COVID-19 in a period when the Del…

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Why COVID-19 booster criteria will remain complicated for now

The FDA has authorized COVID-19 vaccine boosters for many people who are fully vaccinated.

Individuals seeking boosters must currently navigate a sort of checklist to confirm their eligibility.

The criteria for the Janssen vaccine are the simplest: Anyone who has received a single dose of that vaccine can receive an additional dose two months or more after the first.

The Pfizer-BioNTech and Moderna boosters are available to fully vaccinated people 65 or older, provided six months have elapsed after receipt of the last dose. In addition, individuals 18 and older who live in a long-term care facility are also eligible. Those who live or work in high-risk settings also can get the shot, as can individuals with certain medical conditions.

When asked when FDA would authorize boosters to all individuals 18 and older, Dr. Peter Marks, a senior official at FDA, said in a media briefing, “I think we may get…

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White House reveals plan to vaccinate children aged 5 to 11 

Photo by Aaron Kittredge from Pexels

The White House says that vaccination will be readily available and free of charge for children between the ages of five and 11, assuming the FDA and CDC authorize them.

The authorization of a vaccine for that age group would make 28 million additional Americans eligible for vaccination.

Pfizer recently asked FDA to extend emergency use authorization (EUA) to its vaccine, which it jointly developed with BioNTech.

An FDA advisory committee will convene on October 26 to discuss Pfizer’s request to amend the EUA. While some members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) have signaled concern about the risk of myocarditis linked to mRNA vaccines in children in the past, clinical trial data suggest the vaccines are safe and effective in five- to eleven-year-olds.

The White House said it would begin dispensing shots with…

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Abbott rises on Street-beating Q3, increased EPS guidance

Abbott (NYSE:ABT) shares ticked up this morning on third-quarter results that easily topped the consensus forecast.

The Abbott Park, Illinois-based company posted profits of $2.1 billion, or $1.17 per share, on sales of $10.9 billion for the three months ended Sept. 30, 2021, for a 70.5% bottom-line gain on sales growth of 23.4%.

Adjusted to exclude one-time items, earnings per share were $1.40, 46¢ ahead of Wall Street, where analysts were looking for sales of $9.6 billion.

The company’s medical device business registered revenues of $3.6 billion, representing a year-over-year increase of 14.6%. Abbott’s diagnostics business, bolstered by its COVID-19 testing products like the over-the-counter BinaxNow rapid diagnostic, saw 48.2% growth to revenues of $3.9 billion for the quarter.

“We achieved another quarter of strong growth overall and across all four of our major business areas,” Abbott president & CEO Robert B. For…

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FDA to authorize heterologous vaccination 

Media reports suggest FDA will soon permit so-called “mix-and-match” COVID-19 boosters as it prepares to authorize boosters from Moderna (NSDQ:MRNA) and Janssen (NYSE:JNJ).

The move would give healthcare workers more leeway in administering boosters, as The New York Times reported.

During last week’s Vaccines and Related Biological Products Advisory Committee (VRPAC) meeting, preliminary results from a federally-funded study suggested that heterologous boosters were non-inferior to homologous boosters. “The heterologous [recipients] had as good or higher neutralizing antibodies following at day 15,” said Dr. Kristen Lyke, a clinical translational investigator affiliated with the University of Maryland, who spoke during the VRBPAC meeting.

Although the research Lyke referenced was not powered to make definitive comparisons between various heterologous vaccine booster regimens, mRNA vaccines appeared to be more efficacious when used as boosters and overall…

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Johnson & Johnson rises on Q3 earnings beat

Johnson & Johnson (NYSE:JNJ) shares ticked up today on third-quarter results that topped the consensus earnings forecast.

The New Brunswick, N.J.-based company posted profits of $3.7 billion, or $1.37 per share, on sales of $23.3 billion for the three months ended Sept. 30, 2021, for a 3.2% bottom-line gain on sales growth of 10.7%.

Adjusted to exclude one-time items, earnings per share were $2.60, 25¢ ahead of Wall Street, where analysts were looking for sales of $23.7 billion.

Each of J&J’s individual segments saw year-over-year revenue growth, with pharmaceuticals (13.8% increase from 2020) and medical devices (8%) experiencing significant upticks.

“Our third-quarter results demonstrate solid performance across Johnson & Johnson, driven by robust above-market results in pharmaceuticals, ongoing recovery in medical devices, and strong growth in consumer health,” J&J chairman & CEO Alex Gorsky said in a news release. “In…

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The European Union has become a leading COVID-19 vaccine exporter 

The European Union is now one of the largest exporters of COVID-19 vaccines globally, having provided 150 nations with more than one billion vaccine doses.

The U.S. has exported fewer than 200 million vaccine doses to date but has pledged to donate more than one billion.

China has pledged to donate two billion doses by the end of the year. As of September 23, the Chinese foreign ministry stated that China had exported 1.2 billion doses to more than 100 countries.

The EU announced in September that it would provide an additional 200 million doses to low-income countries in Africa and elsewhere.

“We know that other countries also have to step up,” EU Commission President Ursala von der Leyen told the AP. “That’s the only way to beat the pandemic.”

To date, 47.6% of the world’s population has received at least one dose of vaccine, according to Our World in Data. But most of those doses have gone to middle- and high-income nations. Less than 3.…

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FDA hits pause on reviewing Moderna COVID-19 vaccine for adolescents

The FDA has decided to postpone deciding whether to extend emergency use authorization of Moderna’s (NSDQ:MRNA) COVID-19 vaccine.

Some regulators have concluded that the risk of myocarditis is higher in recipients of the Moderna vaccine than the Pfizer-BioNTech vaccine.

Japan recently authorized men 30 and under who received an initial dose of the Moderna vaccine to receive a second dose of the Pfizer-BioNTech vaccine. Japanese authorities also recommended requiring a four-week interval between the first and second doses in this subpopulation — the same as the 28-day interval Moderna recommended for the second dose.

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

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FDA hits pause on reviewing Moderna COVID-19 vaccine for adolescents 

The FDA has decided to postpone deciding whether to extend emergency use authorization of Moderna’s (NSDQ:MRNA) COVID-19 vaccine.

Some regulators have concluded that the risk of myocarditis is higher in recipients of the Moderna vaccine than the Pfizer-BioNTech vaccine.

Japan recently authorized men 30 and under who received an initial dose of the Moderna vaccine to receive a second dose of the Pfizer-BioNTech vaccine. Japanese authorities also recommended requiring a four-week interval between the first and second doses in this subpopulation — the same as the 28-day interval Moderna recommended for the second dose.

Sweden, Denmark, Norway and Finland recently recommended that younger age groups avoid obtaining the Moderna COVID-19 vaccine until further notice.

Health authorities in Europe are scrutinizing data to determine whether the Moderna vaccine increases the risk of myocarditis in younger recipients.

FDA data concerning the Moderna a…

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What to consider before renewing your serialization contract

As we kickstart the last quarter of 2021, the federal deadline for full interoperability in pharmaceutical serialization, as dictated by the DSCSA (Drug Supply Chain Security Act), will soon reach its two-year countdown on November 27. Since November 2018, all manufacturers, including virtual manufacturers and brand owners, have been required to serialize products at the lowest salable unit. Products that do not contain a unique serial number on the packaging, along with other required information (GTIN, serial, lot and expiry date), are not authorized to be sold or purchased. As stated in the guidelines, “Failure to comply with DSCSA can lead to fines, suspension or revocation of license, and even potential imprisonment or civil penalties.”

Technical challenges coupled with a global pandemic have hindered the roadmap towards serialization compliance. Pressured by the supply chain amidst the COVID-19 outbreak, the FDA announced an enforcement discretion on verifying s…

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Bayer abandons plans to produce first-generation CureVac vaccine

Bayer (ETR:BAYN) had planned to retool a facility in Wuppertal, Germany, to produce CureVac’s (NSDQ:CVAC) COVID-19 vaccine. But Leverkusen, Germany–headquartered Bayer has put those plans on ice, according to the German paper Leverkusener Anzeiger.

Bayer had planned on producing 160 million doses of the vaccine annually.

In June, CureVac reported that its COVID-19 vaccine was 48% efficacious in an international Phase 2b/3 study focused on various age groups. Despite having lower efficacy than the mRNA vaccines from rivals Moderna and Pfizer/BioNTech, CureVac had assumed in July that it would receive marketing authorization to distribute the vaccine in Europe.

The company announced it would withdraw its first-generation vaccine candidate, CVnCoV, from regulatory review at the European Medicines Agency. CureVac also canceled an existing advanced purchase agreement with the European Commission related to the CVnCoV vaccine.

Earlier this week, CureVac…

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