Pfizer and Moderna COVID-19 vaccines seek FDA approval after promising clinical test trials

Cassy Tweed | Graphic Courtesy
COVID-19 vaccines are becoming promising but America is still in for a harsh continuation of the pandemic during the winter months.

As of Dec. 1, 2020, there have been 267,302 deaths in the United States that are attributed to COVID-19 according to the Center for Disease Control and Prevention (CDC). On May 15, 2020, the Trump administration announced Operation Warp Speed (OWS) as a public-private partnership to facilitate the development, manufacturing and distribution of COVID-19 vaccines. OWS was funded with $10 billion from the CARES Act passed by Congress and companies have since received hundreds of millions of more in research funding from investors. Moderna rece7ived $1 billion from OWS to help develop its mRNA vaccine, while Pfizer passed on this development money.

Moderna, Inc., a biotechnology company has been working in conjunction with the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) to produce a COVID-19 vaccine. In a press release on Nov. 30, 2020, Moderna announced that Phase 3 of their COVE study of their mRNA-1273 vaccine indicated a high efficacy among all demographics involved in testing, including 100% effectiveness against severe COVID-19 symptoms. 

“The positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Stephane Bancel, Chief Executive Officer of Moderna said.

Moderna expects to have around 20 million doses of mRNA-1273 by the end of the year and the company is on track to manufacture 500 million to one billion doses globally in 2021 according to a Moderna press release. Moderna is working with the CDC, Operation Warp Speed and McKesson (a vaccine distributor) in preparing for approval by the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). 

Pfizer Inc. and German partner BioNTech have also concluded their own Phase 3 study of BNT162b2, their COVID-19 vaccine candidate. Pfizer has announced that their vaccine is 95% effective against COVID-19 beginning 28 days after the first dose. Pfizer and Moderna have both requested EUA’s and hope to hear back by Dec. 17, when a federal committee will meet to determine the distribution methods of the vaccines and who will receive the first vaccinations. 

“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” said Ugar Sahin, M.D., CEO and Co-founder of BioNTech.

“These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.”

The Advisory Committee on Immunization Practices (ACIP) is a federal advisory committee made up of public health experts with the task of making vaccine recommendations. The ACIP has stated that their four goals are to (1) decrease death and serious disease as much as possible, (2) preserve the functioning of society, (3) reduce the extra burden the disease is having on people already facing disparities and (4) increase the chance for everyone to enjoy health and well-being. 

The ACIP has considered four groups of persons for early vaccination: healthcare personnel, workers in essential and critical industries, people at high risk for severe COVID-19 illness due to underlying medical conditions and people 65 years and older. 

Moderna plans to charge $32 to $37 per dose of the vaccine in developed countries and will have cheaper pricing in other parts of the world, according to Barcel. OWS has said that vaccine doses purchased with U.S. taxpayer dollars will be offered free to Americans. However, vaccination providers will be able to charge administrative fees for giving the shots, which can be reimbursed by a patient’s public or private insurance company or by the Health Resources and Services Administration’s Provider Relief Fund if the patient is uninsured. 

According to OWS, it is likely that public vaccinations will begin by Jan. 2021, if not sooner. The top infectious disease expert in the U.S., Dr. Anthony Fauci has said that “the ordinary citizen” should be able to get a vaccine by April, May or June 2021.

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