Tag: covid-19 vaccine

Vial and syringe.

What to Know About the COVID-19 Vaccine Dosing Debate

Dorit Reiss 1 Comment

By Dorit Rubinstein Reiss

Faced with limited COVID-19 vaccine doses and the ever-mounting toll and strain of the pandemic, a new debate has emerged as to the best strategy for allocating the vaccines.

Both COVID-19 vaccines authorized for emergency use in the U.S., which are produced by Pfizer/BioNTech and Moderna, have been studied under two-dose clinical trials. The two-dose regime is thought to accord a more robust immune response against COVID-19.

In the U.K., however, due to concerns about the shortage of COVID-19 vaccines, the government has deviated from established protocols. First, it decided to delay (but not omit) the administration of the second dose of the available vaccines, in order to increase the number of people getting at least one dose; second, it decided to allow mixing and matching of doses across vaccine types.

The United States is considering following the U.K. and moving to give more first doses, at the cost of delaying completion of the series.

Experts are sharply divided on whether that is a good or bad idea.

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Vial and syringe.

Congress Should Enact No-Fault Compensation for COVID-19 Vaccine Injuries

Dorit Reiss 1 Comment

By Dorit Rubinstein Reiss

If COVID-19 vaccines lead to any serious harms, society should compensate those victims generously and quickly.

Currently, under the Public Readiness and Emergency Preparedness (PREP) Act, COVID-19 vaccine manufacturers and providers are immune from liability.

Anyone seeking compensation for a severe side effect from a COVID-19 vaccine needs to go through a government program that is extremely narrow and hard to win; the Countermeasures Injury Compensation Program (CICP). The program requires “compelling, reliable, valid, medical and scientific evidence” to be compensated — a very high bar. It has compensated only a very small percentage of claims submitted over the years.

But we have an alternative. The Vaccine Injury Compensation Program (VICP) provides compensation under a much more generous standard. It has been used for years for childhood vaccines, and has served us well. While not perfect, it offers a decent path forward.

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Person receiving vaccine.

What You Should Know About the COVID-19 Vaccine

The Petrie-Flom Center Staff Leave a comment

Cross-posted from Harvard Law Today, where it originally appeared on December 3, 2020. 

By Jeff Neal

The race to approve and distribute a vaccine for COVID-19 got a huge shot in the arm this week.

On Tuesday, the United Kingdom approved a vaccine developed by pharmaceutical giant Pfizer. On the same day in the United States, a panel of experts advising the Centers for Disease Control and Prevention recommended a first-stage plan for distributing the vaccine to some of the most at-risk Americans. Separately, another advisory committee is set to meet twice in the coming weeks to evaluate for the U.S. Food and Drug Administration the safety and efficacy of both the Pfizer vaccine and a similar one produced by Moderna.

To better understand the impact of these developments, Harvard Law Today recently spoke with public health expert Carmel Shachar J.D./M.P.H. ’10, the executive director of the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School, about the vaccine, who is likely to get it first, and whether employers and states can require people to get vaccinated.

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This 2006 image depicted a nurse, who was administering an intramuscular vaccination into a middle-aged man’s left shoulder muscle. The nurse was using her left hand to stabilize the injection site.

An Equity-Based Strategy for COVID-19 Vaccine Distribution

Megan Shen Leave a comment

By Megan J. Shen

How COVID-19 vaccines roll out in the U.S. will highlight the nation’s priorities, and potentially also its persistent disparities.

Top of the list to receive the vaccine are frontline healthcare workers, who were the first to receive Pfizer’s new vaccine this week.

Next will come long-term care facility residents and workers. This is critical, as long-term care residents have suffered perhaps the most devastating death toll, killing over 100,000 residents.

But there is still a long winter ahead where many will not yet have access to the vaccine. And it remains unclear how the next round of vaccine recipients will be allocated to serve the most vulnerable populations.

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Stacks of books against a burgundy wall

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

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Vial and syringe.

Challenges in COVID-19 Vaccine Rollout: Lessons from the UK

Sravya Chary Leave a comment

By Sravya Chary

Just over a week after the United Kingdom became the first Western country to authorize the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the U.S. Food and Drug Administration (FDA) followed suit on December 11, 2020.

This lag may prove beneficial. The United States can and should cautiously assess the United Kingdom’s vaccination strategy to avoid challenges that may impede its ability to control the virus.

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Spoonful of sugar.

From “A Spoonful of Sugar” to Operation Warp Speed: COVID-19 Vaccines and Their Metaphors

The Petrie-Flom Center Staff Leave a comment

By Ross D. Silverman, Katharine J. Head, and Emily Beckman

As professors studying public health policy, narrative medicine, and how providers and the public communicate about vaccines, we recognize the power and peril of using the rhetorical tool of metaphors in vaccination and, more broadly, the COVID-19 response efforts.

Metaphors can be an effective shorthand to help people understand complex ideas, but we also must remain cognizant of the many ways metaphors may distort, divide, or misrepresent important details.

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Vaccine.

Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines

Sravya Chary Leave a comment

By Sravya Chary

Two COVID-19 vaccine manufacturers recently submitted Emergency Use Authorization (EUA) requests to the Food and Drug Administration (FDA) for their candidates.

While the need for a safe and efficacious COVID-19 vaccine is dire and immediate, an EUA may not be the best regulatory method to provide access. Experts warn that the EUA pathway may impede vital scientific progress needed to establish the long term safety and efficacy of investigational COVID-19 vaccines.

According to the FDA, an Emergency Use Authorization is a tool that allows an unapproved medical product to be released to the public in a health crisis given that the medical product meets statutory criteria outlined in Section 564 of the Federal Food, Drug, and Cosmetic Act.

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Close up of a Doctor making a vaccination in the shoulder of patient.

Authorize Emergency Vaccines for COVID-19, but Do It Well

Holly Fernandez Lynch Leave a comment

By Holly Fernandez Lynch, Alison Bateman-House, and Arthur Caplan

The U.S. Food and Drug Administration (FDA) is expected to grant emergency use authorization (EUA) for one or more COVID-19 vaccines before the end of the year — perhaps even before the end of the day, given today’s advisory committee meeting.

The agency’s decision on these EUAs will balance the need for additional data on safety and efficacy against the potential to protect at-risk groups as quickly as possible. EUAs tip the balance in favor of speed, which can be reasonable for these populations given the circumstances, especially in light of the strong trial data reported for three COVID-19 vaccines since mid-November. But the tradeoff is very real: vaccine EUAs will substantially lower the likelihood of ongoing trials completing and new trials successfully recruiting volunteers. There are a few ways to minimize these consequences.

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people waiting in a line.

Advance Health Equity by Getting Vaccine Distribution Right

Nicolas P. Terry Leave a comment

By Sarah de Guia and Nicolas Terry

The U.S. Food and Drug Administration (FDA) is poised to decide soon whether to authorize the emergency use of COVID-19 vaccines. While this is positive news, critical decisions remain about the equitable allocation of the vaccine.

On December 10, 2020, the FDA will hold a meeting of its vaccine advisory committee to consider an emergency use authorization (EUA) sought by Pfizer/BioNTech for its COVID-19 vaccine candidate. A week later, the committee likely will consider a similar request from Moderna for its candidate. The UK is moving on an even more aggressive timeline and has already approved the Pfizer/BioNTech candidate.

In 2020, it is expected that doses will be ready for only 20 million Americans; there will not be general availability until the second quarter of 2021.

So, who will get the vaccine soonest, and will those decisions be based on equitable criteria?

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