Syringe and vials of vaccine.

Why a COVID-19 Vaccine Shouldn’t be Mandatory

By Dorit Rubinstein Reiss and Y. Tony Yang

A future COVID-19 vaccine will not work without sufficient uptake, and some are considering mandates to get that uptake. Some scholars have gone so far as to call for compulsory vaccination for all U.S. residents in a recent USA Today column.

We believe premature mandates won’t work. In fact, they could backfire spectacularly.

There are several reasons for this. First, once we have an approved vaccine, we will not have enough doses to go around for those who want them. Forget mandates: even if all goes remarkably well, we will begin by producing and distributing tens of millions of doses—not the hundreds of millions needed to cover the entire United States.

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Vials of medications with syringe and needle.

Is “Implied Consent” Ethically Permissible in WHO’s Malaria Vaccine Pilot Introduction?

By Beatrice Brown

A recent BMJ article has exposed ethical concerns with the informed consent process in the World Health Organization’s (WHO) large, randomized cluster trial of the world’s first licensed malaria vaccine, RTS,S, known as Mosquirix. The study is being conducted in Malawi, Ghana, and Kenya, and 720,000 children will receive the vaccine. The vaccine is currently limited to pilot implementation because of residual safety concerns from previous clinical trials, including: a tenfold rate of meningitis in those who received the vaccine versus those who did not, “increased cerebral malaria cases, and a doubling in the risk of death in girls.” Rather than engaging in the traditional informed consent process, the WHO is utilizing an implied consent process, leading several bioethicists, including Charles Weijer, Christine Stabell Benn, and Jonathan Kimmelman, to voice concern.

The WHO has defended their use of implied consent to BMJ on the grounds that “the study is a ‘pilot introduction’ and not a ‘research activity.'” A WHO spokesperson explained that in an implied consent process, “parents are informed of imminent vaccination through social mobilisation and communication, sometimes including letters directly addressed to parents. Subsequently, the physical presence of the child or adolescent, with or without an accompanying parent at the vaccination session, is considered to imply consent.” However, as Weijer rightly points out, this is not truly consent, as “We have no assurance that parents, in fact, received information about the study let alone that they understood it.” After the publication of the original article criticizing the WHO for going against international ethical standards for research involving human participants, the WHO released a response in BMJ and on their own website, contending that this implied consent process is “used for all vaccines provided through the Expanded Programme on Immunization” and that the study is in accordance with international ethical standards. Here, I further explore whether this implied consent process is ethically permissible in this specific trial by exploring the guidelines set out by two organizations.

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U.S.-Mexico border wall in Texas near a dirt road

Targeting Health: How Anti-Immigrant Policies Threaten Our Health & Our Humanity

By Patricia Illingworth and Wendy E. Parmet

On May 19th of last year, Carlos Gregorio Hernandez Vasquez died of the flu while being held in a cell by U.S. Customs and Border Protection (CBP) in south Texas. He was just 16, a migrant from Guatemala. Hours before his death, when his fever spiked to 103, a nurse suggested that he be checked again in a few hours and taken to the emergency room if he got any worse. Instead, Carlos was moved to a cell and isolated. By morning, he was dead.

Sadly, Carlos’s substandard medical treatment was not an isolated case. Between December 2018 and May 20, 2019, five migrant children died while in federal custody. All of them were from Guatemala. Their deaths were not accidental. Rather, they died as a consequence of harsh policies that are designed to deter immigration, in part, by making life itself precarious for migrants.

Since taking office, the Trump administration has instituted a wide-ranging crackdown on immigration. A surprising number of the policies the administration has instituted as part of that crackdown relate directly or indirectly to health. For example, in addition to providing inadequate treatment to sick migrants, CBP has refused to provide flu shots to detainees, despite the fact that influenza, like other infectious diseases, can spread rapidly in overcrowded detention facilities. In dismissing a CDC recommendation to provide the vaccines, CBP cited the complexity of administering vaccines and the fact that most migrants spend less than 72 hours in its custody before being transferred to other agencies, or returned to Mexico. These explanations lack credibility given how easy it is to administer flu vaccines. Read More

First-person perspective photograph of a health care worker holding up a mask used to prevent the spread of germs

The Big Winner in Trump’s Newest Immigration Policies: The Flu

By Robert Field

The influenza virus gained an important ally during the past few weeks: the Trump Administration. If you have been rooting for a widespread and virulent flu epidemic this winter, several of its new immigration policies should give you reason to cheer.

The first bit of good news for flu fans is a decision to withhold vaccination from children held in Customs and Border Protection detention centers. These facilities are supposed to hold migrants for no longer than three days, but many remain much longer, and the centers are often severely overcrowded. Since the flu can be quite serious, this puts the thousands of children held in them at increased risk of major illness or death.

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Photograph of a young girl receiving a vaccination from a doctor

New York’s Strict Vaccine Mandate Goes to Court

By Dorit Reiss

On June 13, 2019 New York repealed the religious exemption from its school immunization mandates. While the actual repeal went fast – the bill passed the Assembly health committee, the Assembly floor, the Senate floor and the Governor’s office on the same day – the bill has been in the process since January, and activists on both sides were active in the lead up to the vote. The bill was a response to a large measles outbreak in New York that sickened hundreds of people and hospitalized over a hundred, sending tens to the ICU.

Not surprisingly, opponents filed lawsuits against the new law. Two of these lawsuits were led by the Children’s Health Defense organization, an anti-vaccine group led by Robert F. Kennedy, Jr., though with two different lead lawyers. Eight additional ones were recently filed by two unassociated lawyers in eight different counties.

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A baby getting vaccinated by a doctor wearing gloves.

The Rockland Ban: The Next Step in the Battle Against Measles

Rockland County, New York’s Executive, Ed Day, issued an emergency declaration last month, banning unvaccinated children from public places. Although this seems like a drastic step, it is the culmination of extensive efforts to stem a large outbreak created by anti-vaccine misinformation. It is also in line with principles of public health.

For months, Rockland county in New York has been battling a large measles outbreak. As of April 2, 2019, the outbreak reached 158 cases. The vast majority of cases – 86 percent – were in minors under the age of 18, and over 50 percent are under six years old. Only 3.8 percent of the victims are fully vaccinated (3.8 percent received two doses of the Measles, Mumps, Rubella vaccine, MMR). And 82.8 percent of cases are known to be unvaccinated. Many of the cases are concentrated in Orthodox Jewish neighborhoods.

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child getting vaccinated

California Court of Appeal Rejects Challenge to Vaccine Law

By Dorit Reiss

The Second Appellate District’s Court of Appeal upheld the California law that removed California’s Personal Belief Exemption (PBE) from school immunization requirements earlier this month.

The decision is a strong endorsement of immunization mandates and is binding on all state courts until another appellate decision is handed down, or the Supreme Court of California addresses the question.

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Baby was receiving his scheduled vaccine injection in his right

Childhood Flu Vaccination and Home Rule in the Big Apple

On June 28, the State of New York Court of Appeals upheld a New York City Board of Health requirement that children between the ages of 6 months and 5 years old attending city-regulated child care or school-based programs receive flu vaccinations.

While New York City is no stranger to progressive public health initiatives, this ruling in particular is significant on at least two accounts. First, it strengthens New York City’s ability to confer the public health benefits of flu vaccination to a wider segment of the adolescent population, consistent with current recommendations. Second, it stands as a reminder of the important role that local health authorities, like boards of health, can play in improving population health, if granted sufficient authority under state law.

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a pile of vaccine vials and a needle

Long Overdue: Check Out the Vaccine Resources Library for Expert Witnesses

By Dorit Reiss, Stanley A. Plotkin, Paul A. Offit

A new tactic has emerged in a few recent family law vaccination cases: using arguments created by the anti-vaccine movement.

Lack of familiarity with anti-vaccine claims can trip up even the most qualified expert. But a new resource library at the Vaccine Education Center at the Children’s Hospital of Philadelphia aims to combat anti-vaccine rhetoric and by giving experts the information they need to respond.

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First, Do No Harm: NGOs and Corporate Donations

By Clíodhna Ní Chéileachair

Last year Médecins Sans Frontières (MSF) refused free vaccinations for pneumonia from Pfizer, who had offered the medicines as a corporate donation to the humanitarian organisation. The explanation MSF provided (available here) makes for an interesting, if uncomfortable read. Looming large is the lengthy history of negotiations between MSF with the only manufacturers of the vaccine, GlaxoSmithKline and Pfizer. MSF claim that the only sustainable solution to a disease that claims the lives of almost a million children each year is an overall reduction in the cost of the vaccine, and not one-off donations that come with restrictions on where MSF may use the medicines, and a constant power disparity between the parties, where Pfizer may release the medication on their own timeline, and revoke access as they see fit.

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