US FDA COVID Vaccine Authorization Important Step Toward Ending the COVID-19 Pandemic

AVAC and TAG Call for Global Cooperation to Ensure Equitable Rollout of Vaccines and Other COVID-19 Interventions

Contacts:
Richard Jefferys: richard.jefferys@treatmentactiongroup.org
Kay Marshall: kay@avac.org, +1-347-249-6375

New York City, December 11, 2020 – Today’s decision by the US Food and Drug Administration (FDA) to grant an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA vaccine is an important step toward bringing the COVID-19 pandemic under control in the United States. The US joins Bahrain, Canada, Mexico, Saudi Arabia and the UK in granting regulatory authorization of the Pfizer-BioNTech vaccine. More countries are expected to authorize this vaccine in the coming days, and the FDA will next week consider an EUA for the Moderna mRNA vaccine. One or more other vaccines are expected to follow in the coming weeks and months, with potential for full regulatory approval for one or more by mid-2021.

An EUA is an important step in the race to get vaccines to all who need them. However, public health history shows that only fully and fairly deployed vaccines will actually end this pandemic. It is past time for a comprehensive global plan that provides a clear framework, funding and clear accountability for equitable access to everyone in the world, regardless of income and ability to pay.

AVAC and TAG call for action in three areas:

A robust, integrated research plan: Policy makers and public health programs need to start planning now for follow-on research related to follow-up of trial participants, expanded populations, operational research to optimize deployment, and the prevention of infection and onward transmission (in addition to prevention of disease). Regulators and trial sponsors must provide a plan for ethically continuing follow-up of participants in the Pfizer- BioNTech trials, including plans for when and how participants will be unblinded and placebo recipients will be offered the vaccine. National regulatory agencies, the World Health Organization, researchers, ethicists, and community representatives must develop recommendations for control arms of ongoing and planned COVID vaccine and prevention trials. In addition, vaccine developers, in conjunction with the FDA and other regulators and in consultation with communities, must articulate and implement a plan for accelerated vaccine research and regulatory review for populations not included in the original studies, including pregnant women and other people who are pregnant and children of all ages. We note that while the efficacy trial included a small number of people with HIV, safety data have yet to be reported due to insufficient follow up–these data should be made available as soon as possible, given that there are likely to be people living with HIV among the priority populations for vaccination.
Rational, fully-funded deployment plans in the US: Under the current administration, there is no well-articulated national deployment plan, and state and local efforts are starved of funding. The Trump administration must immediately begin to work closely with the incoming Biden administration to ensure a coordinated national plan that supports and fully funds local efforts. This must include community-led and -developed plans to build trust in vaccination programs, particularly among historically marginalized populations who have reason to distrust government-sponsored public health plans. These plans should include data-driven programming to ensure that populations most at risk of COVID and on the front lines of essential work have access to vaccines as quickly as possible. And these programs must have effective communication campaigns to address side-effects, safety, and potential adverse events to ensure that concerns, which will inevitably arise, are addressed in a clear, transparent, evidence-based and coordinated manner. Distribution plans must also include equitable vaccine allocation based on risk and need. In addition to the importance of vaccinating people whose age, profession, or preexisting conditions place them at high risk, incarcerated and detained populations have notably not been prioritized in COVID-19 vaccine distribution frameworks, and are absent from some preliminary State plans, despite being one of the most at-risk groups. Black, Latinx, indigenous, and other communities of color face high risk of COVID-19 and of poor outcomes from it due to entrenched structural and racial injustices, and also must be prioritized equitably.
Global commitments to equitable global access: COVID anywhere is COVID everywhere. Vaccine nationalism is unethical and is counterproductive to ending this pandemic. New data released this week shows that 9 out of 10 people in poor countries will not have access to COVID-19 vaccines in the next year, while the world’s richest countries have reserved up to 5 times as many vaccine doses as they need for their citizens. The US and other wealthy countries must abandon this vaccine nationalism and work with COVAX and other international programs to ensure equitable global access. In addition, the research pipeline must be optimized to speed development of vaccine formulations that will be easier to store and deliver in areas with underdeveloped health infrastructure. Vaccine manufacturing capacity must be enhanced, including technology transfer and waiving intellectual property protection during the pandemic, to ensure the maximum number of doses of safe and effective vaccines and in keeping with the massive public investments that have underwritten the development and distribution of these innovations.

In testimony at the FDA Advisory Committee hearing on Thursday, Mitchell Warren, AVAC executive director said: “The FDA process is not just about authorization or approval; it is a beacon of independent review and transparency that will help foster the trust necessary to re- build confidence in vaccines, in science and in our public institutions.”

“This is a tremendous step forward,” Warren said. “But if we’ve learned anything in almost four decades of fighting HIV, it’s that proven and approved interventions only reach those who need them most when there are well designed, fully funded programs to deliver them.”

Mark Harrington, executive director of the Treatment Action Group (TAG), adds “the rapid development of safe, effective vaccines for preventing COVID-19 is a testament to what can be achieved with sound science, political will, and adequate resources. In addition to ensuring that all have access to these innovations in keeping with the human right to science, our governments must expand investments in research and delivery to ensure similar achievements to end other infectious pandemics, including HIV, tuberculosis, and hepatitis C.”

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic.

About TAG: Treatment Action Group (TAG) is an independent, activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine, and a cure for HIV, tuberculosis, and hepatitis C virus. TAG works to ensure that all people with HIV, TB, and HCV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions.