The FDA has fully approved the Moderna Covid vaccine

The FDA has fully approved the Moderna Covid vaccine

/ 10:48 AM February 01, 2022

Moderna Covid-19 vaccine now on the same side with Pfizer as a fully authorized vaccine. The US Food and Drug Administration grants Moderna full approval to their COVID-19 vaccines. They were the second approved and licensed COVID-19 vaccine in the US.

Although their COVID-19 vaccine name is Moderna, this newly vaccine will be out in the market as Spikevax. In the meantime, it’ll only be available for adults 18 years and above. Here are some key points to take note of the Moderna vaccine.


  • A COVID-19 vaccine that was authorized for emergency use of individuals 18 years and older.
  • Spikevax passed the FDA’s approval for effectiveness, safety standards, and manufacturing quality.
  • This COVID-19 vaccine has the same formulation as the original Moderna Covid vaccine.
  • Similar to their pre-approved COVID-19 vaccine, it also has two doses. With one month gap for each dose.
  • The two-dose series for adults is still available under EUA (emergency use authorization).
  • The third primary dose was intended for adults with records of immunocompromised conditions.
  • A single booster dose for adults at least 5 months after completing a primary series of vaccines.
  • This COVID-19 vaccine is approved for a “mix and match” single booster dose for adults 18 years and older.
  • Common side effects of the Covid vaccine based on clinical trials are as follows. You can experience fatigue, headache, swelling and redness of the jabbed part, muscle and joint pains, chills, fever, vomiting, and nausea. As well as swollen lymph nodes under the arms.

Moderna CEO Stephanie Bancel tweeted, “This is a momentous milestone in Moderna’s history.”

Is Moderna Vaccine Safe

FDA conducted a series of studies and investigations on certain cases of pericarditis (inflammation of the heart tissue) and myocarditis (heart muscle inflammation). Based on the findings, it shows that there’s a higher risk of these heart conditions after the second dose.

Although complete information for potential long-term health effects is not yet available. Moderna has been clear about these warnings on their Spikevax Prescribing Information data.


The US FDA is still requiring Moderna to conduct further studies to assess the pericarditis and myocarditis cases. Moreover, Moderna has agreed and will also conduct studies for pregnancy and infant outcomes after Spikevax vaccination.

The US FDA based their approval on clinical data of 30,000 individuals. The trial showed that the vaccine was an effective and safe vaccine against COVID-19. Another data basis is real-world data using the Moderna vaccine. Whereas, tens of millions of people in the US have received the Moderna shots.

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TAGS: Covid vaccine, interesting topics, Moderna, US FDA
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