Moderna Seeks Emergency Coronavirus Vaccine Approval from FDA

Moderna filed an emergency approval request with the U.S. Food and Drug Administration (FDA) on Monday for its coronavirus vaccine, which touts high efficacy in preventing severe infections.

The vaccine, known as mRNA-1273, has had remarkable success in its clinical trials, according to ABC News, showing 94.5% effectiveness in preventing COVID-19 infections and 100% success in preventing severe cases of the viral disease.

In a phase-three trial of 30,000 participants, the Moderna coronavirus vaccine was tested against a placebo to measure its efficacy.

Of those participants, only five vaccinated patients were diagnosed with COVID-19. In comparison, 90 placebo participants ended up catching COVID-19. These results support Moderna’s claims of 94.5% efficacy.

The trial also showed the vaccine was 100% effective in preventing severe COVID-19 infections. All cases of severe COVID-19 infection were reportedly seen in the placebo group with no severe cases in the vaccinated group.

Although these results cannot definitively say that the vaccine will prevent severe disease amongst a wider population, the trial outcomes are extremely promising.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, called these results “very exciting” and “truly outstanding” after the vaccine’s clinical trial results were announced in November.

Moderna’s coronavirus vaccine works by using messenger RNA — a piece of genetic code — to direct the body to create a “spike” protein, stimulating the body to respond to the virus, according to The Associated Press. This protein trains immune cells to recognize COVID-19, allowing the body to fight infection if it encounters the real virus.

According to the trial results, no serious side effects are associated with the coronavirus vaccine. However, some mild reactions have been reported such as injection site redness and soreness, headaches, fever, fatigue and other symptoms.

“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,” Stéphane Bancel, Moderna’s chief executive officer, said in a press release, according to Business Wire.

In order to secure FDA approval, Moderna must participate in a public debate with scientific advisers on the Vaccines and Related Biological Products Advisory Committee about the safety of their coronavirus vaccine Dec. 17.

Two other biopharmaceutical companies, Pfizer and BioNTech, will also present data that their vaccine is 95% effective in a meeting a week earlier, on Dec. 10. These debates will question whether there is enough data to support approval for each of the proposed vaccines.

If the Moderna coronavirus vaccine is approved, the company estimates that 20 million doses could be available in the U.S. by the end of the year, the AP reported. With each patient needing two doses, this is enough to vaccinate 10 million Americans.

Distribution of these doses could begin within 24 hours of FDA approval, according to Moderna.

In addition to applying for emergency approval with the FDA, Moderna has asked European regulators for approval of their coronavirus vaccine.

The British government has reportedly ordered 7 million doses of Moderna’s vaccine along with 40 million doses of the Pfizer-BioNTech vaccine.

Other coronavirus vaccines are still in the works from notable pharmaceutical companies such as Johnson & Johnson and AstraZeneca.

AstraZeneca is reportedly seeking emergency authorization from the World Trade Organization to distribute its proposed vaccine in low-income countries.

The coronavirus pandemic was first identified in Wuhan, China, in December 2019. Since then, COVID-19 has spread around the world — resulting in over 63 million cases and more than 1.4 million deaths, according to the BBC. The U.S. leads the world in both of these statistics with over 13 million total cases and more than 266,000 deaths.

If Moderna’s coronavirus vaccine is approved by the FDA, it could mark an end to the days of countrywide quarantines and severe social distancing measures.

However, this may only be possible if the vaccine is accessible and affordable.

Global charity Oxfam responded to Moderna’s announcement with its own statement, urging the company to take measures to ensure the coronavirus vaccine is both affordable and accessible.

“While the amazing effectiveness of the vaccine candidates is encouraging, we must remember they will be zero percent effective for those who cannot access them,” Oxfam America senior advisor Niko Lusiani said in a statement.

“That’s why every COVID-19 vaccine must be a people’s vaccine: patent-free, mass produced, distributed fairly, and made available free of charge, to every individual, rich and poor alike.”

Although Moderna previously said that it wouldn’t enforce seven patents in connection to its coronavirus vaccine while the world is gripped by the pandemic, Oxfam argues further action should be taken to ensure the vaccine is a “public good.”

Will you get the coronavirus vaccine once it becomes available? Let us know in the comment section.

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