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COVID-19: Prevention and Treatment Options

Vaccination and treatment for eligible patients: a two-pronged approach for COVID-19

From the beginning, we understood that fighting COVID-19 would require the power of science and unprecedented collaboration among scientists, companies, governments, and other stakeholders around the world.

We know that vaccinations have played an important role in public health by helping to protect us from serious diseases and helping to reduce the burden of once common infections.

While vaccinations remain one of the first lines of defense to help protect people against COVID-19, for those who do get COVID-19, there are authorized oral treatment options available for eligible patients who are diagnosed with COVID-19 and are at high risk of progressing to severe illness [including hospitalization or death].

Since 2020, we have been working on a two-pronged approach focused on prevention through vaccinations and treatment through oral medication.

There is still more work to be done, though. At Pfizer, we remain unwavering in our commitment to combatting COVID-19.

Prevention through vaccination

Prevention through getting eligible people to get vaccinated remains critical to help in the fight against COVID-19.

That’s why, in 2020, we set out to make the impossible possible. In collaboration with BioNTech, we delivered a breakthrough COVID-19 vaccine to the world. We developed our COVID-19 vaccine using mRNA, or messenger RNA. We worked with tremendous urgency, without compromising quality, coordinating closely with trial participants and investigators, regulatory bodies, other companies, and governments to bring this vaccine forward.

Our success was made possible in part due to Pfizer’s longstanding history in vaccine research, development, and delivery, which dates back more than a century.

Today, while clinical and real-world data still show that existing COVID-19 vaccine options can help protect against the virus, we are continuing to follow the science and exploring new vaccine approaches that may be needed as the pandemic evolves. In the meantime, we believe that the one of the best safeguards against the spread of COVID-19 is getting all eligible people up to date with their vaccination schedule.

Oral treatment for eligible patients diagnosed with COVID-19 and at high risk of progressing to severe illness

In early 2020, recognizing the urgency and escalation of the COVID-19 pandemic across the globe, we assembled a committed, multidisciplinary team and initiated a clinical program to support the development of an oral treatment, specifically designed to help inhibit the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus.

Pfizer researchers identified our most promising candidate—an oral protease inhibitor—to progress into clinical studies and, ultimately, received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the treatment of eligible patients diagnosed with COVID-19 at high risk of progressing to severe illness. Since then, it has been approved or authorized for conditional or emergency use by many regulatory authorities around the world.

Manufacturing and access to COVID-19 vaccine and treatment

Since 2020, we have continued to scale up our at-risk manufacturing efforts to expand vaccine and treatment access to different populations, based on local authorization or approval. 4.6 billion Pfizer-BioNTech COVID-19 vaccines have been distributed, with more than 1 billion delivered to low- and middle-income countries. As of April 17, 2023, we have shipped more than 52 million courses (inclusive of more than 50 million courses delivered) of PAXLOVID total to date to 78 countries around the world.

We remain committed to working toward broad, equitable, and affordable access to Pfizer’s COVID-19 vaccine and oral COVID-19 treatment for eligible patients around the world and are working with governments and other appropriate partners on a tailored approach.

  • While vaccines are one of the best ways individuals can help reduce their risk of infection, COVID-19 cases are still possible, and some people are at high risk for severe illness. Therefore, it is important that we have treatment options available to support individuals who are at high risk of becoming severely ill from the virus. This is why both vaccines and treatment options are necessary to help reduce the burden of COVID-19 disease.

  • COVID-19 oral treatments may be right for you if you are at high risk of progressing to severe illness. Talk to your doctor for individual medical advice.

  • Clinical and real-world data show that COVID-19 vaccines can help protect against COVID-19, particularly against the risk for severe disease and hospitalization. However, if you are at high risk for severe illness and do get sick or infected, you should speak with your doctor about treatment options as soon as possible.

  • Your best resource for individual medical advice is your doctor.

  • COVID-19 is highly unpredictable, and we believe that both vaccination and treatment for eligible patients play coordinated, critical roles in helping to protect people, along with other broad interventions.

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

U.S. FDA Emergency Use Authorization Statement

PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild-to-moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.