Moderna, a US-based pharmaceutical company has applied to the FDA authorization of its covid-19 vaccine. The company has asked the US FDA for authorization to administer the drug to patients after a review of its expanded data.
According to recent news reports, the company’s vaccine is 94.1% effective at immunization. Moreover, the company also claims 100% effectiveness in averting severe cases of the novel coronavirus. In response, some FDA members have noted positive surprise, thanks to the surprising effectiveness of the vaccine.
Dr. Paul Offit, a member of the FDA’s vaccine advisory committee said the results were striking and amazing.
The head of Moderna’s vaccine development program, Dr. Tal Zaks noted that he became overwhelmed with emotions when he witnessed the data for the first time on Saturday. He said this was the first time he allowed himself to cry. Dr. Zaks said, “We have full expectations to change the course of the pandemic.” Furthermore, the company is the second in the race to apply for authorization with Pfizer leading the way with its promising efficacy.
A Quick FDA Approval Process Anticipated
The FDA on its part will likely conduct a thorough analysis before granting approvals. The FDA’s advisory committee will likely meet in December to review applications. Moreover, the dosage of the vaccine will also be administered to people soon.
Dr. Anthony Fauci, the director of the National Institute of Allergy, and Infectious Diseases said, “the vaccination in the United States will occur towards the latter part of December.”
Moderna will also apply for authorization to reach out to millions of more patients in Europe soon. The company will soon be applying for authorization with its promising results from the European Medicines Agency, and Infectious Diseases.
Moderna’s latest data is based on its phase 3 trials, which were conducted on human beings. In its phase 3 trials, Moderna conducted medical trials on 30,000 individuals with its vaccine, and placebo medicine. Among the people treated with the vaccine, only 11 developed coronavirus later on. On the other hand, among those treated with a placebo, 185 individuals were diagnosed with coronavirus.
Additionally, among 11 individuals who received the vaccine, no one developed a serious medical condition. On the other hand, among other groups of participants, 30 developed a chronic condition, resulting in one fatality.
Pfizer’s vaccine also remains a bright horizon for millions who reeling from the deadly virus. However, despite its higher efficacy, its study revealed that one person developed a serious condition after the vaccination. On the other hand, the company claims a higher efficacy with 95% rates. Both vaccination programs are different from each other. However, they both deploy messenger RNA to incite an immune response. The side effects from the dosage, which are separated by a few weeks, remain comparatively negligent like bodge aches, or fever.