J&J files for emergency use clearance for its COVID-19 vaccine

WHAT YOU NEED TO KNOW:

• On Thursday, Johnson & Johnson (J&J) submitted an application for emergency-use authorization of its COVID-19 vaccine to the Food and Drug Administration.
• Compared to Pfizer/BioNTech and Moderna’s vaccine, J&J only has a single dose with an efficacy rate of 66 percent against the virus.
• The FDA is set to review J&J’s application on Feb. 26.

Johnson & Johnson (J&J) filed for an emergency-use authorization of its one-shot COVID-19 vaccine on Thursday to the Food and Drug Administration (FDA), giving the Americans a third option in choosing a vaccine to protect themselves against contracting the coronavirus.

Based on an international study, J&J vaccine’s efficacy rate is 66 percent versus moderate to severe infection, but it could give strong immunization against hospitalization and death.

The vaccine, which is only a single-dose (compared to Pfizer and Moderna’s two-doses), would be more applicable for people who are more vulnerable, those in remote areas and other skeptics, public health authorities noted.

It can also be kept in regular refrigerators versus the other vaccines that need freezing temperature storage.

The dose, however, was found to be less effective versus a deadlier COVID-19 variant at 57 percent, which was initially recorded in South Africa during a clinical trial. 

The variant, known as B.1.351, was already spreading in the US. Experts have cautioned that it could also adopt the UK variant that would make it more resistant against the vaccine.

“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. We are working with great urgency to make our investigational vaccine available to the public as quickly as possible,”, J&J’s chief scientific officer Paul Stoffels said in a statement.

J&J initially assured the federal government that it would distribute over 12 million doses in January and 100 million in the spring. Last month, though, it gave an advisory that the enormous allotment would have to wait until the end of April upon completion, a source familiar with the matter said.

The company announced that it would send a conditional marketing authorization to the European Medicines Agency in the weeks to come. It has also “initiated rolling submissions with several health agencies outside the U.S.”

The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to decide about J&J’s proposal on February 26. Granting of clearance is expected to be released in a couple of weeks.

As one of the first drugmakers funded by the US government to develop a vaccine, J&J has received over $456 million for its clinical trials and later made a $1 billion deal with the government in exchange for 100 million doses.

J&J’s vaccine allocation will be added to Pfizer/BioNTech and Moderna’s 200 million (each) vaccine doses that would be utilized for Americans nationwide. Pfizer and Moderna have also expressed their interest to provide another 100 million shots.

Source: Politico