J&J announces promising COVID-19 booster data, delays on kids' vaccine trial

·Senior Reporter
·3-min read

Johnson & Johnson (JNJ) announced promising booster data Tuesday showing 94% efficacy for its COVID-19 vaccine when given after six months of the initial dose.

In addition, the initial dose of the vaccine continued to provide consistent protection against the virus, including against the Delta variant, the company said in a statement.

The latter news puts the vaccine in stark contrast to mRNA vaccines, which have shown waning immunity over time.

Mathai Mammen, J&J's global head of R&D, told Yahoo Finance the company has submitted all the data to the U.S. Food and Drug Administration (FDA) and is awaiting a response on if it can file for a booster authorization.

"Ultimately, that will be decided by FDA, and the population that such a booster would impact is decided by CDC," Mammen said.

Last week, an advisory panel to the FDA voted unanimously to recommend a booster dose of the Pfizer (PFE)/BioNTech (BNTX) vaccine for those older than 65 years, and for anyone who is at a high risk of contracting severe COVID-19, such as frontline health workers. 

The FDA has yet to decide on the recommendation, and the U.S. Centers for Disease Control and Prevention (CDC) is holding its advisory panel meeting this week to recommend guidance on booster doses. President Joe Biden's COVID-19 Response Team had targeted this week to begin booster doses for all adults in the U.S., in an announcement last month.

"The advisory committee, I thought, did a good job studying all aspects of the Pfizer vaccine. I think that there are different circumstances for different vaccines, and different circumstances in different parts of the world," Mammen said.

A pre-print of real-world data using health insurance claims showed strong protection in more than 390,000 vaccinated individuals in the U.S.

The data showed protection against COVID-19 was 79%, and protection against hospitalization was 81%. Data to support the announcement for the booster shot was not available Tuesday.

Delay in kids' vaccine trial

Despite the positive booster data, J&J is lagging in providing a single-shot vaccine for kids.

The company has not yet begun its pediatric trial for ages 16 and under, putting it well behind competitors like Moderna (MRNA), and far behind Pfizer, which just submitted data for 5-11 year olds to the FDA and anticipates shots in arms by Halloween.

J&J previously targeted a fall start date, but Mammen said it could be later this year.

"Our trials with children and pediatric population(s) won't start till later this year," Mammen said.

He explained that the coordination with global regulatory bodies was holding up the process.

"We have to agree protocols with the different regulators around the world. So we're not able to say exactly until there's such agreement," he said.

Follow Anjalee on Twitter @AnjKhem

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