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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 primary series vaccinations and boosters remain one of the first lines of defense to help protect people against COVID-19, for those who do test positive for COVID-19, there are now authorized oral treatment options available for appropriate patients who are at high risk of developing severe illness.

Since 2020, we have been working on a two-pronged approach focused on prevention through primary series vaccination and booster shots, and through oral treatment.

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 complete a primary series of vaccination and booster shots 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 in record time. We developed our COVID-19 vaccine using mRNA, or messenger RNA. Prior to that, no mRNA vaccine had ever been authorized or approved and, thus, one had never been manufactured at scale by any company. 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 best safeguard against the spread of COVID-19 is getting all eligible people up to date with their vaccination schedule.

Oral treatment for appropriate high-risk patients who test positive for COVID-19

In early 2020, recognizing the urgency and escalation of COVID-19 across the globe, we assembled a committed, multidisciplinary team and initiated a clinical program to develop 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 —a protease inhibitor— to progress into clinical studies and, ultimately, received the first U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for an oral COVID-19 treatment. 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. As of July 3, 2022, more than 3.6 billion Pfizer-BioNTech COVID-19 vaccines were shipped to 180 countries in every region of the world. And, in anticipation of the potential for regulatory authorization or approval, Pfizer initiated early, at risk manufacturing of our oral treatment; by the end of June 2022, we had shipped more than 23.3 million courses of our oral treatment to 40 countries around the world.

We remain committed to working toward equitable access to Pfizer’s COVID-19 vaccine and oral COVID-19 treatment for people around the world at an affordable price 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 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 appropriate patients who test positive play coordinated, critical roles in helping to keep people protected, along with other broad interventions.

Emergency uses of the vaccines 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 6 months of age and older (Pfizer-BioNTech COVID-19 Vaccine)
  • individuals 12 years of age and older (Pfizer-BioNTech COVID-19 Vaccine, Bivalent)

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 mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, 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.