FDA Commissioner Hahn and Deputy Shah: Coronavirus vaccine search – here’s what we’re doing to defeat COVID-19

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Dr. Fauci: 'No guarantee' we will have a safe, effective vaccine

To accelerate the development of multiple novel vaccine candidates, the Trump administration has tapped the best scientific minds and committed billions of dollars to Operation Warp Speed. This historically unprecedented effort is laser-focused on developing a proven, effective COVID-19 vaccine that can reach Americans in record time.

In doing so, ensuring the safety of a vaccine will always take precedence. Long the world’s gold standard for drug safety, the Food and Drug and Administration (FDA) is synonymous with consumer trust and strict adherence to science-guided integrity.

Developing and manufacturing an effective vaccine is only half the battle. In order for the vaccine to protect the vulnerable and halt the spread of the virus, Americans must be confident in their own minds that they can take it safely.

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Unfortunately, recent polling finds only half to two-thirds of Americans say they would be willing to receive a vaccine once it becomes available – even as we maintain exceptionally high rates of vaccination for many other diseases.

This week, we at the FDA issued guidance to medical innovators with recommendations to facilitate the manufacturing, clinical development and approval of a safe and effective COVID-19 vaccine. This guidance will facilitate the rapid progress on vaccines by recommending to developers ways to meet the standards for safety and efficacy with speed and efficiency.

There are two reasons that widespread vaccination against the coronavirus that causes COVID-19 is so essential to the public health.

First, and obviously, the virus is potentially deadly for all ages – especially the elderly – because we have no preexisting immunity. Humans have developed a degree of baseline genetic immunity for most other diseases we vaccinate against. But we generally do not have such natural defenses against a novel virus.

Unfortunately, recent polling finds only half to two-thirds of Americans say they would be willing to receive a vaccine once it becomes available.

Second, the virus spreads easily and sustainably, including from individuals unaware that they are infected – a risk seen with relatively few viruses. Vaccines can alert our immune systems to identify, contain and destroy microorganisms such as viruses, potentially both preventing disease in the individual as well as spread to others.

Vaccine development is challenging, especially against a newly identified pathogen like the one that causes COVID-19. Scientists must first develop promising vaccine candidates. These are then rigorously tested – initially in laboratory experiments, then in animal models, and finally in humans – to determine if they can provoke an immune response without causing serious side-effects.

Biopharmaceutical companies and government agencies then carefully design large-scale clinical trials to assess whether the vaccine is protective against infection in diverse populations.

While the FDA is generally not involved in executing the development of medical products, we provide feedback and guidance on issues ranging from trial design to product labeling to assuring consumers that a vaccine will perform as intended.

Ultimately, FDA is a regulatory agency created to serve, protect and promote the public health. Independent of political considerations, we carefully review new medical products using the agency’s time-honored standards of safety and effectiveness.

The application of FDA’s institutional knowledge and scientific expertise will ensure that any vaccine given to Americans for the prevention of COVID-19 will have been thoroughly and thoughtfully evaluated.

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Vaccines have always been fundamental to our mission, with the agency following a rigorous review process for each of the more than 50 vaccines currently licensed for use in the United States.

The president and all of America’s public health leaders – including our team at the FDA – recognize the urgent need for an effective COVID-19 vaccine. A safe and effective vaccine will not just protect us from this deadly virus, it will allow life in America to return to normal with the risks from exposure vastly reduced.

In order to get there, however, no corners can be cut. Guaranteeing the safety of a new vaccine isn’t just a paramount FDA priority – it’s our moral guidepost as medical professionals.

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Despite the need for speed, we remain steadfast in our commitment to science – and to following the data in our decision-making.

While we cannot predict when the vaccine will be available, we can promise that when it is, the FDA will have ensured its safety and effectiveness on behalf of the American people.

Dr. Anand Shah is deputy commissioner for medical and scientific affairs of the U.S. Food and Drug Administration.