Scientist Holding Moderna Vaccine

Moderna Applies For Emergency Use Authorization Of Covid-19 Vaccine In US And Europe

Moderna announced today that it would be asking US and European regulators to allow emergency use authorization of its Covid-19 vaccine. The submission is a result of new study data confirming that the shots offer a very strong protection against the coronavirus. 

Moderna quickly followed Pfizer in their announcement of the development of a vaccine, which is crucial considering multiple Covid-19 vaccines will need to be made available in order for the pandemic to come to a true close. Moderna created its shot treatment with the US National Institutes of Health, and according to the company this past weekend’s data showed that the vaccine is more than 94% effective. 

Within the massive US clinical trial that Moderna performed, 196 participants became infected with Covid-19. Of that number, 185 received the placebo vaccine, while the other 11 got the real vaccine. The only individuals who got severely ill with the virus were those who received the placebo as well, proving the vaccines effectiveness. Dr. Tal Zaks, one of Moderna’s chief medical officers, recently rejoiced with the media about this amazing advancement. 

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“I allowed myself to cry for the first time, we have already, just in the trial, saved lives. Just imagine the impact then multiplied to the people who can get this vaccine.”

Moderna claims that so far they’ve only seen temporary flu-like side effects come from the vaccine, the same type of symptoms that appear after getting a regular flu shot. The safety data up until this point has already met the US Food and Drug Administrations (FDA) requirements for emergency use, the company just needed to complete its final trial testing before it could have all the necessary information for the FDA’s review. 

The European Medicines Agency, which is like Europe’s version of the FDA, will also likely be granting Moderna with emergency use authorization in the coming weeks. Before the FDA approves either vaccine from Moderna or Pfizer a panel of scientific advisers will publicly debate if there’s enough evidence to release either or both vaccines to the public. 

Pfizer and German tech partner BioNTech will present their vaccine data to the FDA on December 10th and Moderna is set to present theirs on December 17th. If approved, Moderna expects to distribute 20 million doses within the US by the end of the year. Recipients need two doses, meaning the initial rounds will go to 10 million people. 

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Pfizer projects that they’ll be able to distribute 50 million doses throughout the world in December if approved; 12.5 million of those doses are reserved for the US. If the FDA approves of either of the vaccines they will begin being shipped within 24 hours. This week a panel of experts established by the US Centers for Disease Control and Prevention will also be meeting to decide how the vaccine will be distributed throughout the country once approved. 

The first doses will likely be reserved for health care workers who are at the most risk of exposure, and then will go to higher risk groups like the elderly and immunocompromised. As the vaccine’s continue in their development and distribution, other essential workers and individuals at higher risk for infection will receive their doses first. “Higher risk” could also be determined based on location and how severe the Covid-19 outbreaks have been for certain parts of the country. 

The UK ordered 40 million doses of the Pfizer-BioNTech vaccine, however, that doesn’t mean the company’s December supply will all be going to the UK at first. Like in the US, all parts of the world will have their own plans for distribution to higher risk/healthcare workers initially. Both Moderna and Pfizer have used messenger RNA from the Covid-19 virus itself to make their vaccines, which is why these two have likely proven to be the most effective around the same time. 

As the world continues to wait to see when and how these vaccines will be distributed, continue to listen to your healthcare providers and follow all the necessary precautions to protect yourself, and your loved ones.

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