US gives full approval to Moderna's COVID-19 vaccine
A vial of the Moderna COVID-19 vaccine is displayed on a counter at a pharmacy in Portland, Oregon, Monday, December 27, 2021.

WASHINGTON, United States (AP) — US health regulators on Monday granted full approval to Moderna's COVID-19 vaccine, a shot that's already been given to tens of millions of Americans since its emergency authorisation over a year ago.

The action by the Food and Drug Administration means the agency has completed the same rigorous, time-consuming review of Moderna's shot as dozens of other long-established vaccines.

The decision was bolstered by real-world evidence from the more than 200 million doses administered in the US since the FDA cleared the shot in December 2020. The FDA granted full approval of Pfizer's vaccine last August.

Public health advocates initially hoped the regulatory distinction would boost public confidence in the shots. But there was no discernable bump in vaccinations after the Pfizer approval, which was heavily promoted by President Joe Biden and other federal officials. Still, regulators said Monday they hoped the extra endorsement would encourage more people to get vaccinated.

More than 211 million Americans, or 63 per cent of the total population, are fully vaccinated. About 86 million people have gotten a booster dose. Vaccinations peaked last spring at more than three million per day, and now average less than 750,000 per day. The pace of vaccinations briefly spiked following news of the omicron variant in December but has since slowed again.

The FDA reviewed months of additional follow-up data submitted by Moderna to confirm the vaccine's effectiveness against COVID-19. The FDA also analysed and kept watch for serious side effects that have proved to be very rare. The vaccine includes a warning about a rare type of heart inflammation that mostly occurs in young men following the second dose. Most cases are mild and resolve quickly.

Additionally, FDA reviewed the company's manufacturing process and facilities.

“The public can be assured that this vaccine was approved in keeping with the FDA's rigorous scientific standards,” said Dr Peter Marks, FDA's top vaccine regulator, in a statement.

With full approval, Moderna will now market the vaccine under the brand name, Spikevax. It is the first FDA-approved product for the Cambridge, Massachusetts-based company.

In the US, Moderna is used only by adults, for initial vaccination and as a half-dose booster. The company said last fall that FDA had delayed deciding whether to clear the shots for 12- to 17-year-olds as it examined the heart inflammation risk.

Johnson & Johnson has not yet applied for full approval of its COVID-19 vaccine.

Now you can read the Jamaica Observer ePaper anytime, anywhere. The Jamaica Observer ePaper is available to you at home or at work, and is the same edition as the printed copy available at https://bit.ly/epaper-login

HOUSE RULES

  1. We welcome reader comments on the top stories of the day. Some comments may be republished on the website or in the newspaper; email addresses will not be published.
  2. Please understand that comments are moderated and it is not always possible to publish all that have been submitted. We will, however, try to publish comments that are representative of all received.
  3. We ask that comments are civil and free of libellous or hateful material. Also please stick to the topic under discussion.
  4. Please do not write in block capitals since this makes your comment hard to read.
  5. Please don't use the comments to advertise. However, our advertising department can be more than accommodating if emailed: advertising@jamaicaobserver.com.
  6. If readers wish to report offensive comments, suggest a correction or share a story then please email: community@jamaicaobserver.com.
  7. Lastly, read our Terms and Conditions and Privacy Policy