PHILADELPHIA (KYW Newsradio) -- Johnson & Johnson officially filed a request to get emergency-use authorization for its one-dose COVID-19 vaccine. This brings the U.S. a step closer to having a third vaccine in the fight to slow the spread of the coronavirus.
The drugmaker announced it sent the EUA application to the U.S. Food and Drug Administrstion on Thursday. The FDA then said it scheduled a meeting of its vaccine advisory panel for Friday, Feb. 26. This is the same group of independent experts that met and recommended the authorization of the Pfizer and Moderna vaccines late last year.
If regulators with the FDA and CDC end up giving the thumbs-up, doses could start going out quickly.
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping," Dr. Paul Stoffels, Johnson & Johnson's chief scientific officer, said in a company press release.
This new vaccine requires just one shot per person, compared to the two-dose regimen for Pfizer and Moderna. It can also be stored at regular refrigeration and not the ultra-cold temperatures that Pfizer's and Moderna's vaccines require.
Johnson & Johnson says Phase 3 clinical trials, involving nearly 44,000 participants in the U.S., Latin America and South Africa, showed the vaccine was 66% effective overall. There is concern from health officials that it was less effective in South Africa, where a highly contagious variant of the coronavirus was first detected. Efficacy was 57% there compared to 72% in the United States. As of Friday morning that variant was detected in five people in the U.S. -- three in Maryland and two in South Carolina.
One of the major advantages of this new vaccine, according to the company, is 85% effectiveness in preventing the most severe COVID symptoms and keeping people out of the hospital.
"And because there's no excipients in order to make the vaccine, there is no allergic reaction worry and so patients can come in and can leave right away," said CBS Medical Advisor Dr. David Agus.
Johnson & Johnson has an agreement with the U.S. government to distribute 100 million doses in the country by the end of June, which would help with the supply issues experienced by state and local governments.
