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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Syringe and vials of vaccine.

How Does Moderna’s COVID-19 Vaccine Work, and Who Is Funding Its Development?

Cross-posted from Written Description, where it originally appeared on August 19, 2020. 

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Moderna, Inc., a Cambridge, MA-based biotech company, is a leading contender in the race to develop a SARS-CoV-2 vaccine. Moderna’s vaccine, however, works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world. Despite this, the U.S. government—and two agencies in particular, the NIH and Biomedical Advanced Research and Development Authority (BARDA)—has invested, heavily, in the vaccine’s development. This week, we explore how these investments interact through different forms of research partnerships, and what this says about IP, novel technologies, and innovation policy.

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a pile of vaccine vials and a needle

COVID-19 Vaccine Advance Purchases Explained

Cross-posted from Written Description, where it originally appeared on August 5, 2020. 

By Nicholson PriceRachel SachsJacob S. Sherkow, and Lisa Larrimore Ouellette

No vaccine for the novel coronavirus has been approved anywhere. Nevertheless, governments and international organizations around the world are announcing deals for billions of dollars to procure tens of millions of doses of vaccines from companies that are still running clinical trials, including a $2.1 billion deal with Sanofi and GSK announced by the US on Friday. What’s going on? And what do these deals tell us about innovation policy for COVID-19 vaccines? In this post, we lay out the landscape of COVID-19 vaccine pre-purchases; we then turn to the innovation impact of these commitments, and finish by asking what role patents and compulsory licensing have to play.
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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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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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Image of a child in a blue dress with pigtails receiving a vaccination injection.

Social Media’s Anti-Anti-Vaxxer Fight Ramps Up

According to the World Health Organization (WHO), “vaccine hesitancy,” which is “the reluctance or refusal to vaccinate despite the availability of vaccines” is among the top ten threats to global health in 2019. While there are many complex reasons why people may choose not to vaccinate their children, social media has received a great deal of scrutiny for its role in empowering and financing the movement opposing vaccines. Platforms have taken a wide range of actions in response.

Pinterest, for example, demonstrated an aggressive tactic, banishing results that are associated with certain searches related to vaccines, “regardless of whether those results might have been reputable.“In 2017, the platform altered its “community guidelines” after a 2016 study revealed that 75 percent of vaccine-related posts were negative. The guidelines aim to prevent misinformation and advice that has “immediate and detrimental effects on a pinner’s health and public safety,” and explicitly state that “[t]his includes . . . . anti-vaccination advice.” Now, if a user attempts to search “vaccination,” they’ll see a result stating “Pins about this topic often violate our community guidelines, so we’re currently unable to show search results.” And while users can still pin images related to vaccines, their posts won’t be visible in searches.

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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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How the New York Court of Appeals Applied the Soda Cap Criteria to Vaccines

By Dorit Reiss

New York’s Court of Appeals reversed an Appellate Division decision and reinstated New York City’s influenza mandate for city daycares in Garcia v. New York City Department of Health and Mental Hygiene in June. Applying the same criteria the court used in 2014 to overturn the city’s controversial Soda Cap, the court found that the rules are well within the Board’s authority.

We can suspect that the recent influenza season influenced the decision, but it was also based on a more explicit delegation of authority, and a history of vaccination programs by the Board.

Also, it’s likely good news for at least some of New York’s youngest, who will be better protected from a dangerous disease, and for the public.

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