Johnson & Johnson COVID-19 vaccine cleared for use in US

JOHNSON & JOHNSON’S (J&J) coronavirus vaccine was cleared for use in the US, making a third shot available that could plug gaps in the nation’s immunization campaign as concern grows over an influx of virus variants.

The Food and Drug Administration (FDA) said in a statement on Saturday that it had granted an emergency-use authorization for the single-dose vaccine for people 18 and older.

The decision comes after virus deaths topped 500,000 in the US and as health officials raise alarms that a recent decline in new cases may be stalling.

The J&J shot is highly effective at preventing severe coronavirus disease 2019 (COVID-19), with no serious side effects, agency staff said in a report Wednesday. On Friday, a committee of outside advisers to the FDA voted unanimously that the vaccine’s benefits outweigh any risks. In the week ahead, J&J is prepared to ship 3 million to 4 million doses.

“We’re in a race between the virus mutating — new variants coming out that could cause further disease — and stopping it,” said Jay Portnoy, director of the division of allergy, asthma and immunology at Children’s Mercy Hospital, who supported an emergency authorization. “We need to get this vaccine out.”

The clearance is another milestone in an unprecedented global scientific sprint. Since the World Health Organization declared the coronavirus a pandemic nearly a year ago, numerous vaccines have been deployed around the world, including shots developed in China and Russia. Worldwide, more than 231 million doses have been administered in 100 countries, according to data collected by Bloomberg.

J&J’s shot is expected to be easier to distribute and administer than the Pfizer, Inc.-BioNTech SE vaccine and the Moderna, Inc. shot that were cleared by the FDA late last year. To reach full effectiveness, the earlier shots require two doses several weeks apart. They must also be kept at very cold temperatures, while J&J’s doses can be stored in a refrigerator for long periods.

President Joseph R. Biden hailed the vaccine’s authorization, calling it “exciting news” in a statement on Saturday.

“Thanks to the brilliance of our scientists, the resilience of our people, and the eagerness of Americans in every community to protect themselves and their loved ones by getting vaccinated, we are moving in the right direction,” Mr. Biden said.

The inoculation drive in the US has accelerated in recent weeks, with more than 70.5 million doses given as of Friday, according to Bloomberg’s Vaccine Tracker. However, Mr. Biden cautioned that the rise of the new coronavirus variants still poses a threat.

Fast-spreading mutations first reported in the UK, South Africa and Brazil have appeared in the US, while domestic variants spotted in California and New York are raising new concerns among some scientists.

J&J is on track to supply 20 million doses to the US by the end of March, and 100 million by the end of June, an executive said at a congressional hearing on Feb. 23. Globally, J&J expects to produce 1 billion doses this year. Regulators in the European Union could clear the shot in early March.

J&J’s shot is unlikely to be the last to come available in the US Both AstraZeneca Plc and Novavax, Inc. are expected to seek authorization in the coming months for their vaccines, pending results of big US trials that are now fully enrolled.

DIFFERENT PLATFORM

J&J’s vaccine is made from a common cold virus that doesn’t replicate in the body but triggers an immune response to fight off infection. In the US portion of a more than 43,000-person global trial, it was found to be 72% effective at preventing moderate to severe COVID.

That is a lower overall efficacy rate than the Pfizer-BioNTech and Moderna vaccines, which are based on technology called messenger RNA that primes the body to ward off the virus. Each of those was found to be more than 90% effective.

Still, all three shots are extremely reliable at preventing hospitalizations and deaths. And J&J’s does that quickly, with protection against severe disease starting only seven days after vaccination, and ramping up over the course of about two months.

Public-health officials hope that as more people get them, they will greatly reduce the strain the pandemic has placed on the health-care system. Already, more people in the US have received at least one vaccine dose than have tested positive for the virus.

The FDA prescribing document for J&J’s vaccine said not to give it to individuals with a known history of severe allergic reaction, including anaphylaxis, and that sites giving the shots must have treatments for managing such reactions. The same protocols are in place for the shots from Pfizer and Moderna.

The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most were mild to moderate in severity and lasted one to two days. —