White House unveils plans to roll out jabs for 5 to 11 year olds; FDA authorizes Moderna, J&J boosters

White House unveils plans to roll out jabs for 5 to 11 year olds; FDA authorizes Moderna, J&J boosters

By PharmaCompass

2021-10-21Impressions: 1431

White House unveils plans to roll out jabs for 5 to 11 year olds; FDA authorizes Moderna, J&J boosters

This week, Phispers has more updates on Covid vaccines and boosters. Novavax’s Covid-19 vaccine program may have hit a brick wall — a news report says the company is facing significant hurdles in garnering regulatory approval for its Covid vaccine. This indicates a serious setback to WHO’s Covax initiative, though Novavax is denying the news.

The US Food and Drug Administration (FDA) has authorized Moderna and J&J boosters for seniors and high risk groups. The White House has unveiled a plan to roll out Covid-19 vaccines for children aged five to 11 years, pending emergency use authorization (EUA) by the FDA. There is also news that US health officials may recommend reducing the minimum age for getting a booster dose of Pfizer and Moderna vaccines to 40 years.

The FDA has approved Boehringer Ingelheim’s supplemental Biologics License Application (sBLA) for Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar with Humira (adalimumab). The approval places BI in a strong position vis-à-vis other adalimumab biosimilar developers. Six adalimumab biosimilars have been approved and are due to enter the US market in 2023.

Bristol Myers Squibb (BMS) scrapped its partnership with BeiGene pertaining to the chemotherapy drug Abraxane in China. BeiGene sees this as a “tactical maneuver” adopted by BMS to reduce its damages in an ongoing legal fight between the two drugmakers.

In other news, J&J has filed for bankruptcy protection for its newly created subsidiary, LTL Management, set up to manage the burden of lawsuits pertaining to its talcum products. However, some 30,000-odd plaintiffs, who allege the talc causes cancer, say they will “resist the ploy”.


Covid update: White House unveils plans to roll out jabs for 5 to 11 year olds; FDA authorizes Moderna, J&J boosters

On Wednesday, the White House unveiled a plan to roll out Covid-19 vaccines for children aged five to 11 years, pending emergency use authorization (EUA) by the US Food and Drug Administration (FDA).

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
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According to a CNN news report, the Biden administration has secured ample supply of Covid-19 shots to vaccinate the 28 million children falling in the five to 11 age group.

Vaccine advisers to the FDA are scheduled to meet next week to consider Pfizer’s request to authorize its vaccine to five to 11 year olds. The Pfizer vaccine is currently approved for people aged 16 years and older, and has FDA’s EUA for 12 to 15 year olds. Last month, Pfizer had said a phase 2/3 trial had proven that its Covid-19 vaccine was safe and generated a “robust” antibody response in children in the five to 11 age group.

Along with this announcement, the White House also announced a partnership with the Children’s Hospital Association “to work with over 100 children’s hospital systems” across the US to set up vaccination sites “in November and through the end of the calendar year.” The administration also plans to make vaccination available at school and other “community-based sites”. Moreover, the US Department of Health and Human Services will also carry out a national public education campaign “to reach parents and guardians with accurate and culturally responsive information about the vaccine and the risks that Covid-19 poses to children.”

While many experts on Twitter saw this as a repeat of last month’s announcements pertaining to booster shots, in the backdrop of some FDA experts opposing their use, some like Jason L. Schwartz of the Yale School of Public Health dismissed such talk. According to him, the White House is doing it right this time, as there is “no specific talk about dose timing etc.”

FDA authorizes booster doses of Moderna, J&J’s Covid vaccines: On Wednesday, the FDA authorized booster doses of the Covid-19 vaccines from Moderna and Johnson & Johnson (J&J). The agency also said that Americans can choose a different shot from their original inoculation as a booster. In fact, a study conducted by the National Institutes of Health (NIH) has said that recipients of the J&J vaccine may be better off receiving a second shot from Moderna or Pfizer-BioNTech.

With these EUAs, all the three Covid-19 vaccines being administered in the United States can now also be given as boosters to some groups. Last week, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) had unanimously backed Moderna’s Covid boosters for seniors (those 65 years and older) and high risk groups. The panel had also unanimously recommended EUA for a second dose of the J&J vaccine, provided the first shot came at least two months ago.

While the initial Moderna vaccination consists of two 100-microgram shots, the company says a single 50-microgram shot should be enough for a booster.

Last month, FDA had granted an EUA to Pfizer-BioNtech’s Covid-19 vaccine for the elderly and adults with ‘high-risks’. In the case of Pfizer’s booster dose, the agency had to scramble to get the committee to vote in favor of a booster. This time, VRBPAC unanimously backed the Moderna and J&J shots.

FDA may lower age for Pfizer, Moderna boosters: A CNN news report said US health officials are likely to recommend reducing the minimum age for getting a booster dose of Pfizer and Moderna vaccines to 40 years. I believe it will happen,the report quoted a source as saying.

The source said there is growing concern within the FDAthat US data is beginning to show hospitalizations among people under the age of 65 years, who have been fully vaccinated.

If the FDA backs lowering the age for boosters, the plan would then go to the CDC for its sign-off.

Delay in EUA for Moderna’s jab for adolescents: The FDA is delaying its decision on authorizing Moderna’s Covid-19 vaccine for adolescents in order to check if it increases the risk of a rare inflammatory heart condition, known as myocarditis.

According to a report published in the Wall Street Journal, the FDA has been inspecting the risk of myocarditis among younger men vaccinated with Moderna’s vaccine, as compared to the one from Pfizer. Earlier this month, Finland, Sweden and Denmark paused the use of Moderna’s shot for younger males due to reports of myocarditis.

Meanwhile, the European Medicines Agency said on Monday it was evaluating use of the Pfizer-BioNTech Covid-19 vaccine in children as young as five years.


Novavax faces significant hurdles in getting regulatory nod for its Covid jab, says report

On Tuesday, Politico reported on how Novavax is facing significant hurdles in garnering regulatory approval for its Covid-19 vaccine. The report has quoted three sources with direct knowledge of Novavaxs problems.

The report claims the methods used to test the purity of Novavax's Covid-19 vaccine, which is yet to get regulatory approval in any country, have failed to meet regulatory standards. Low purity levels increase the chance of contaminants in the final product, thereby reducing the vaccine’s efficacy and introducing risks for patients.

The World Health Organization’s Covax initiative, which has already faced significant delays, is now likely to fall short by the 1.1 billion doses pledged by Novavax. The WHO has been banking on American firms to provide over 2 billion doses to low- and middle-income nations by 2022-end.

Last year, the US government had invested US$ 1.6 billion in Novavax in the hope that they would get another option to fight Covid-19. However, the company has been dealing with manufacturing issues for many months now, along with challenges in finding enough trial participants.

In March 2020, Emergent BioSolutions had announced an agreement with Novavax whereby Emergent was to provide contract development and manufacturing (CDMO) services to produce Novavaxs influenza vaccine NanoFlu. The Baltimore location was also to produce Novavax’s experimental Covid-19 vaccine candidate. However, following the production problems at the Baltimore plant, Operation Warp Speed moved Novavaxs candidate out of Emergents facility and the company then turned to Fujifilm for production.

On its part, Novavax has hit back at the Politico report. In a statement, it said it remains confident of its ability to deliver as many as 150 million doses per month by the end of the fourth quarter. It said it expects to complete regulatory submissions in key markets including the United Kingdom, Canada and Australia within the next couple of weeks.


J&J seeks bankruptcy protection for its subsidiary to manage talc lawsuits

Johnson & Johnson has filed for bankruptcy protection for its newly created subsidiary, LTL Management, established to manage thousands of lawsuits that allege its talcum products cause cancer. This tactic is referred to as the Texas two-step, and was first used by firms decades ago as a way to mitigate costs associated with asbestos claims.

While we continue to stand firmly behind the safety of our talc products, we believe resolving this matter as quickly and efficiently as possible is in the best interests of the company and all stakeholders,J&Js general counsel Michael Ullmann said in a statement. J&J has set up a US$ 2 billion trust for LTL.

But the plaintiffs arent going to let it off easily. Lawyers representing more than 30,000 women who have brought the claims say they will resist the ploy.

It seems inconceivable that bankruptcy involving a highly profitable US$ 500 billion company could be contemplated, let alone become reality,Andy Birchfield of law firm Beasley Allen said in a statement. It seems hypocritical that such a company could defend a product it claims to be safe, while seeking bankruptcy protection for marketing that same product it knew to be dangerous.

In August this year, a US judge had declined to issue a restraining order against the company. Earlier this year, in a Securities and Exchange Commission filing, the company had estimated its talc-related liabilities at US$ 3.9 billion. But Beasley Allen has put the figure at US$ 25 billion.


FDA grants interchangeable status to Boehringer Ingelheim’s Humira biosimilar

The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s supplemental Biologics License Application (sBLA) for Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar with Humira (adalimumab).

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

The interchangeable designation allows pharmacists more flexibility to sell this more affordable product. The status also gives Boehringer Ingelheim a marketing edge over six other adalimumab biosimilars slated to enter the US market in 2023. Boehringer’s Cyltezo will be among the first to launch, based on the settlements AbbVie has struck with the companies.

The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases. This latest approval designates it as interchangeable across all of these indications.

An interchangeable biosimilar must first meet the high FDA standards of a biosimilar. In order to achieve the interchangeable designation, the FDA requires an additional clinical study of multiple substitutions in patients. This type of study shows how patients do when they are switched back and forth multiple times from a reference product to the interchangeable biosimilar candidate.


BMS scraps Abraxane deal with China’s BeiGene amid legal, production-related woes

A partnership between Bristol Myers Squibb (BMS) and BeiGene pertaining to the chemotherapy drug Abraxane in China has been scrapped by the former, and the American drugmaker’s Chinese partner is in complete disagreement with that decision.

Last week, BMS and its Celgene unit informed BeiGene that they are withdrawing Abraxanes China rights from a basket licensing deal Celgene signed in 2017. The termination will take effect 180 days from the notice.

Though BMS says the reason behind the move was its inability to make Abraxane from two manufacturing sites (one in Illinois operated by CDMO Fresenius Kabi and another in Phoenix owned by BMS), BeiGene sees this as atactical maneuverbeing used by BMS to reduce its damages in an ongoing legal fight between the two.

In an SEC filing, BeiGene said it “intends to contest the purported termination vigorously.According to an analyst, whats at play here is the immuno-oncology rivalry between BMSOpdivo and BeiGenes Novartis-partnered tislelizumab.

In July 2017, BeiGene had signed a deal with Celgene Logistics Sarl, which is now a subsidiary of BMS. The deal was a license and supply agreement giving BeiGene the exclusive right to distribute and market Abraxane, Revlimid and Vidaza in China, barring Hong Kong, Macau and Taiwan.

Abraxane was a major part of that portfolio, making up for half of BeiGenes 2019 revenues. But in March 2020, Chinas drug regulators suspended import of Abraxane, citing manufacturing breaches at the Fresenius facility in Illinois.

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Image Credit : Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0

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