As of January 26, 2021

 

Working across the health care ecosystem, biopharmaceutical companies, academia, hospitals and the public sector are collaborating with urgent dedication to bring about new medicines and vaccines that can help combat COVID-19.

 

Here’s the latest on how biopharmaceutical researchers are working to advance vaccines and treatments, investigate the disease, and discover potential ways to fight back.[i]

 

Vaccines

 

Preventive vaccines help the body develop immunity to the coronavirus by imitating an infection, teaching the immune system how to identify and target the virus that can lead to COVID-19 without actually causing an infection.

 

On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the first vaccine for the prevention of the novel coronavirus that causes COVID-19. This vaccine was developed and subsequently authorized using novel mRNA technology and represents a historic milestone in vaccine science, given the unprecedented R&D timeline. A week later on December 18, 2020, a second mRNA vaccine for the novel coronavirus received an EUA as well. Additional candidates under investigation have also demonstrated promising clinical results.

 

Treatments

 

Potential treatments for COVID-19 generally fall into four categories: antibody therapies, antiviral therapies, immunoglobulins/convalescent plasma and therapeutics approved for other indications.

  • Antibody therapies, such as monoclonal antibodies are designed to recognize coronavirus surface proteins, that could be used to both prevent and treat COVID-19.
  • Antiviral therapies work by attacking the virus directly, often by disrupting the virus’s ability to replicate itself. One antiviral therapy has received FDA approval for the treatment of COVID-19 requiring hospitalization.
  • Immunoglobulins or convalescent plasma treatments are produced by harvesting blood plasma from people who have recovered from COVID-19. This plasma contains antibodies capable of fighting the virus, which are isolated and injected into patients currently fighting COVID-19 to boost their immune response. To date, the FDA has issued an EUA for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients to fight COVID-19.
  • Therapeutics approved for other indications include medicines that are already approved to treat diseases like malaria and other infectious diseases. In some cases, doctors have found these treatments may be helpful in fighting COVID-19, and biopharmaceutical companies are working closely with regulatory authorities including FDA to ensure they are available if and when they are shown to be safe and effective for use in COVID patients.

 

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PhRMA COVID-19 Treatment Progress

America’s biopharmaceutical companies are coming together to achieve one common goal: ending COVID-19. Our shared heritage of discovery and research allows us to respond to the coronavirus swiftly, with active trials for both treatments and vaccines already underway.

By The Numbers

 

As of January 26, 2021, current efforts to develop treatments and vaccines for COVID-19 include:

  • 1 antiviral therapy has received FDA approval for the treatment of COVID-19
  • 2 vaccines have received an EUA from the FDA
  • 5 treatments have received EUAs from the FDA
  • More than 1,612 clinical trials for experimental treatments and vaccines are in development for COVID-19.[ii]
  • 545 unique therapies are in clinical trials
  • 67 unique vaccines are in clinical trials
  • More than 245 clinical trials have been expanded to take place in 45 States and the District of Columbia and about half of those U.S.-based clinical trials are sponsored by industry.
  • 1 month is how long it took to sequence the virus, which is a necessary first step before developing a vaccine. The first vaccine was ready for study in patients just 2 months later. In comparison, it took 20 months to have a vaccine ready to test in SARS patients a decade ago.

 

Partnerships And Collaboration

 

Responding effectively to a public health emergency requires close collaboration between public and private organizations around the world to share insights that could accelerate treatment and prevention strategies. Throughout the battle with COVID-19, leading PhRMA member companies have been collaborating with relevant U.S. and global public health authorities, including the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO), to understand how pandemic preparedness platforms can be tailored to address the current emergency, and how to accelerate the development of potential treatments and vaccines.

“We always need a pharmaceutical partner. I can’t think of a vaccine, even one in which we’ve put substantial intellectual and resource input, that was brought to the goal line without a partnership with industry. So this is a very natural process that we’re doing right now,” said Anthony Fauci, director of the U.S. National Institute for Allergy and Infectious Diseases. “I have not seen in my experience situations in which we were involved in the development of a vaccine, particularly for low- and middle-income countries that really needed it, where the pharmaceutical companies priced it out of their reach.”

Learn more about the efforts underway to develop solutions to help diagnose, treat and prevent COVID-19.

 

 

[i]The following data represents U.S. sites, U.S. companies contributing to clinical trials overseas, and non-U.S. companies and sites generating data overseas
[ii]Numbers subject to change.