FDA Rejects India-Made Bharat Biotech Vaccine For Those Under 18 | FDA declines pediatric EUA for Ocugen's COVID vaccine Covaxin |

[Golwalkar]

The F.D.A. rejects an India-made Covid vaccine for those under 18.

 

A health worker preparing a shot of Covaxin Covid vaccine developed by Bharat Biotech at the vaccination center in New Delhi, last year. Credit...Rajat Gupta/EPA, via Shutterstock

By Rebecca Robbins

• March 4, 2022

 

The American pharmaceutical company Ocugen said on Friday that the Food and Drug Administration had rejected its application seeking emergency authorization for an India-made Covid vaccine for those ages 2 to 18.

The vaccine, made by the Indian pharmaceutical company Bharat Biotech, has not yet been tested in the United States, nor has it been authorized for any age groups in the United States. It is not clear if the vaccine has a path forward with American regulators, when the country already has a surplus of authorized doses.

A clinical trial in India that enrolled those ages 2 to 18 found that two doses of the vaccine generated strong immune responses and did not cause serious side effects. Another large-scale clinical trial in adults in India found that the vaccine provided good protection against Covid, with very strong protection against severe disease. Both of those studies were conducted pre-Omicron, when earlier versions of the virus were circulating.

The vaccine is widely used in India. It has been authorized in about 20 countries as well as by the World Health Organization. Ocugen has a deal with Bharat to try to bring its vaccine to the U.S. market.

 

 

Pfizer makes the only Covid vaccine authorized in the United States for those ages 5 to 17. There are no vaccines currently authorized for younger children, but those ages 6 months through 4 years of age could become eligible for Pfizer’s vaccine as soon as next month.

Representatives of the F.D.A. did not immediately return a request for comment on Friday. The agency generally declines to comment on medical products it has declined to authorize.

Ken Inchausti, a spokesman for Ocugen, said the company is “disappointed” by the agency’s decision. The company said in a news release that it still wants to try to find a path forward for the vaccine to be made available for 2- to 18-year-olds in the United States. Ocugen’s stock fell 23 percent on Friday.

Ocugen is continuing to seek full approval for the vaccine in the United States. The company has said it plans to soon start enrolling adult volunteers in the United States for a clinical trial that will evaluate the immune response generated by the vaccine.

Rebecca Robbins joined The Times in 2020 as a business reporter focused on covering Covid-19 vaccines. She has been reporting on health and medicine since 2015. @RebeccaDRobbins

https://www.nytimes.com/2022/03/04/world/fda-bharat-biotech-vaccine.html

 

[Golwalkar]

FDA declines pediatric EUA for Ocugen's COVID vaccine Covaxin

Reuters

1 minute read

Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech's COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical Sciences (AIIMS) hospital in New Delhi, India, January 16, 2021. REUTERS/Adnan Abidi/Files/File Photo

March 4 (Reuters) - Ocugen Inc (OCGN.O) said on Friday U.S. regulators have declined to issue an emergency use authorization (EUA) for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for use in individuals aged 2 to 18 years.

Shares of Ocugen slumped 30% premarket on the news.

Ocugen said it intends to continue working with the U.S. Food and Drug Administration to evaluate the process for getting an EUA for pediatric use of Covaxin.

Ocugen had entered into a deal with vaccine maker Bharat Biotech in late 2020, under which it would develop, supply, and commercialize Covaxin for the U.S. market. (https://reut.rs/35nVA1P)

Covaxin, which is not cleared for any age group in the United States, is one of the two most widely used COVID vaccines in India and also has an emergency use listing from the World Health Organization.

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-declines-pediatric-eua-ocugens-covid-vaccine-covaxin-2022-03-04/

 

[Golwalkar]

This is not to alarm anyone but to present developments in this rollout space as they happen. 

This whole c-word thing is far from done and dusted. That much I assure you. 

It's important to maintain vigilance about findings & proceedings in the space. 

There is nothing to be gained by developing partisan attitudes toward public health issues. One needs an unbiased & objective eye when observing these things. 

There has been & will continue to be lots of misinformation on every side of this issue. You will be hearing about this for years ( & decades ?!? ) to come. 

Some recent stuff :

 

 

 

 

[Golwalkar]

The illusion of evidence based medicine

 

635,264 views Mar 26, 2022

The illusion of evidence based medicine

https://www.bmj.com/content/376/bmj.o702

https://www.bmj.com/company/the-story-of-bmj-2/

https://journals.bmj.com/home

Evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia, argue these authors Jon Jureidini, research leader

https://www.adelaide.edu.au/directory/jon.jureidini

Research Leader, child psychiatrist Adelaide

Leemon B. McHenry, professor emeritus

Emeritus Professor, Cal State University

Not commissioned, externally peer reviewed

Solid scientific foundation for medicine

Validity of this new paradigm

Reliable data from clinical trials,

Mostly conducted by the pharmaceutical industry

THE JAPANESE JOURNAL OF ANTIBIOTICS
74―1 61( 61 )

http://jja-contents.wdc-jp.com/pdf/JJA74/74-1-open/74-1_44-95.pdf

Global trends in clinical studies of ivermectin in COVID-19 

Morimasa Yagisawa, Patrick J. Foster, Hideaki Hanaki, Satoshi Ōmura

Kitasato University asked Merck & Co., Inc. to conduct clinical trials of ivermectin for COVID-19 in Japan. 

This company has priority to submit an application for an expansion of ivermectin’s indications, since the original approval for the manufacture and sale of ivermectin was conferred to it. 

However, the company said that it had no intention of conducting clinical trials. 

The release into the public domain of previously confidential pharmaceutical industry documents,
valuable insight into the degree to which industry sponsored clinical trials are misrepresented

Until this problem is corrected, evidence based medicine will remain an illusion

Karl Popper

Critical rationalism, advocated for the integrity of science and its role in an open, democratic society

A science of real integrity practitioners are careful not to cling to cherished hypotheses, and take seriously the outcome of the most stringent experiments

This ideal is, however, threatened by corporations, financial interests trump the common good

Medicine is largely dominated by a small number of very large pharmaceutical companies, that compete for market share, but are effectively united in their efforts to expanding that market. 

Scientific progress is thwarted by the ownership of data and knowledge because industry suppresses negative trial results, fails to report adverse events, and does not share raw data with the academic research community. 

Patients die because of the adverse impact of commercial interests on the research agenda, universities, and regulators.

Hierarchical power structures, product loyalty, 
and public relations propaganda over scientific integrity. 

Universities, have adopted a neo-liberal market approach, actively seeking pharmaceutical funding on commercial terms. 

As a result, university departments become instruments of industry: through company control of the research agenda, and ghostwriting of medical journal articles and continuing medical education, academics become agents for the promotion of commercial products.

The corporate university also compromises the concept of academic leadership. 

Deans, (proper academics) have in places been replaced with fundraisers and academic managers, 
who are forced to demonstrate their profitability or show how they can attract corporate sponsors. 

In medicine, those who succeed in academia are likely to be key opinion leaders (KOLs in marketing parlance), whose careers can be advanced through the opportunities provided by industry,
physicians are selected based on their influence on prescribing habits of other physicians

KOLs are sought out by industry for this influence and for the prestige that their university affiliation brings to the branding of the company’s products. 

KOLs present results of industry trials at medical conferences and in continuing medical education.

Instead of acting as independent, disinterested scientists and critically evaluating a drug’s performance, they become what marketing executives refer to as “product champions.”

While universities fail to correct misrepresentations of the science from such collaborations, 
critics of industry face rejections from journals, legal threats, and the potential destruction of their careers.

This uneven playing field is exactly what concerned Popper when he wrote about 
Suppression and control of the means of science communication (Popper)

Regulators receive funding from industry, and use industry funded and performed trials to approve drugs, without in most cases seeing the raw data. 

Drug companies, “mark their own homework”

Our proposals for reforms liberation of regulators from drug company funding
taxation imposed on pharmaceutical companies to allow public funding of independent trials anonymised individual patient level trial data posted, along with study protocols,

[Golwalkar]

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

 

1,511,383 views Mar 16, 2022

For researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. 

A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. 
Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. 

After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson , emailed a complaint to the US Food and Drug Administration (FDA).

Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Read the full investigation: 
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

 

 

https://www.bmj.com/content/375/bmj.n2635