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peter doshi :: Article Creator New Research Reports On Financial Entanglements Between FDA Chiefs And The Drug Industry An investigation published by The BMJ today raises concerns about financial entanglements between US Food and Drug Administration (FDA) chiefs and the drug and medical device companies they are responsible for regulating. Regulations prohibit FDA employees from holding financial interests in any FDA "significantly regulated organization" and the FDA says it takes conflicts of interest seriously, but Peter Doshi, senior editor at The BMJ, finds that financial interests with the drug industry are common among its leaders. Doshi reports that nine of the FDA's past 10 commissioners went on to work for the drug industry or serve on the board of directors of a drug company. That includes Margaret Hamburg, who led FDA between 2009 and 2015, but whose story is less well known. Like her colleagues, Margaret Hamburg h

Will Israel Mandate COVID-19 Vaccination? - Precision Vaccinations

The prospect of Israel making it mandatory to get an experimental vaccine against the new coronavirus has quickly become a concern, commented Ronny Linder in an editorial published by The Haaretz.

‘This possibility didn't emerge from thin air, but rather comments by the professionals in charge of managing Israel’s COVID-19 pandemic response.’

Chezy Levi, the Health Ministry director-general, said in a recent interview that “a way has to be found to force people to immunize … we are in talks with the attorney general about this and clarifying whether there’s a way to make it mandatory to get vaccinated against the coronavirus.”

“I would definitely want to advance a law that would require people to get vaccinated if it does not pose any medical risk to them,” reported Linder on November 13, 2020.

According to precedent, Israel’s Ministry of Health (MOH) is generally responsible for public health crisis management. And the MOH is authorized to classify specific diseases as “communicable diseases,” and to declare a public health crisis caused by such diseases.

As of November 12, 2020, Israel has confirmed over 2,700 fatalities related to COVID-19 during 2020.

Theoretically, the legal infrastructure for mandating vaccinations already exists in Israel. 

Section 19 of the Public Health Ordinance allows for fines to be imposed on anyone refusing to immunize during an epidemic. And in Section 20 of this ordinance, authorizing forcible immunization during an epidemic, but only of certain people, namely, public figures, pilgrims, immigrants, passengers, or people suspected of having been at recent risk of contagion, reported Kinder.

In 2017, a study by the Israel Journal of Health Policy Research concluded ‘A mandatory vaccination backed by criminal sanctions in the service of the eradication of contagious diseases would probably be perceived as infringing on the constitutional right to autonomy to a greater extent than necessary according to Israeli law and case law precedents.’

Yet, during the measles outbreak in Israel, and in other Jewish communities during 2018-2019, when children’s health was at risk, lawmakers did not pursue ‘mandatory’ vaccination laws.

Given the option of choosing between positive and negative incentives, most under-immunized people in Israel, New York, New Jersey and elsewhere, decided to get the Measles-Mumps-Rubella (MMR) vaccination. 

Those decisions led to the measles outbreak’s ending faster than it started.

The two obvious differences between the recent measles outbreak and the current COVID-19 pandemic are related to vaccine efficacy and the vaccination risk/benefit analysis for affected populations.

As of mid-November 2020, the leading COVID-19 vaccine candidates are classified as ‘experimental’ and lack normal clinical efficacy data for a new vaccine to be approved by the U.S. Food and Drug Administration (FDA). 

The current pandemic’s fatality reports are motivating public health leadership to encourage the FDA to issue Emergency Use Authorizations for these experimental vaccines. Even though most new vaccines take about 8 years to complete clinical studies in the USA.

A second consideration for any vaccine committee to debate is should experimental vaccines be authorized for a population segment, children, without vaccine efficacy data. And should children, who are the least impacted group by COVID-19, be forced to be vaccinated.

Recently, the New York Bar Association issued a recommendation for the state to consider mandating a ‘safe and effective vaccine if voluntary measures fail to protect public health.’

However, as of June 2020, all 50 US state school immunization laws grant exemptions to children for medical reasons, states the National Conference of State Legislatures website.

Moreover, there are 45 states and Washington D.C. that grant religious exemptions for people who have objections to immunizations. 

And there are 15 states that allow philosophical exemptions for those who object to immunizations because of personal, moral, or other beliefs.

During an “Ethics Talk” videocast from the AMA Journal of Ethics® on September 29, 2020, Debbie Kaminer, JD, a professor in the Department of Law at Baruch College, explained that states and the federal government ‘have the law on their side if they needed to enact mandates to ensure sufficient vaccination rates.’

But, Kaminer argued, that is not the best way to go about ensuring Americans get a COVID-19 vaccine.

Mandates “are heavy-handed,” she said. “They can be divisive. They can backfire and then the end result is it’s going to increase tensions,” she said. “What you can have instead are more targeted policies.”

Currently, there are no COVID-19 vaccines authorized or approved by the FDA and recommended by the CDC’s Advisory Committee on Immunization Practices. An updated list of experimental COVID-19 vaccine candidates pending authorization is published by CoronavirusToday on this webpage.

PrecisionVaccinations publishes research-based vaccine news.



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