WHO lists J&J COVID-19 vaccine for emergency use

COVAX vaccine shipment
COVAX vaccine shipment

Présidence de la République du Bénin / Flickr cc

The World Health Organization (WHO) today announced that it has listed the one-dose Johnson & Johnson COVID-19 vaccine for emergency use, which adds a more agile option for immunizing people in developing countries.

In another vaccine development, the WHO said its safety committee is reviewing reports of blood clots in people who have received doses from certain batches of the AstraZeneca-Oxford vaccine, but emphasized that the vaccine can be used while the probe is underway.

J&J green-light adds another COVAX option

Given as one dose and stored at normal refrigeration temperatures, the Johnson & Johnson vaccine is the fourth COVID-19 vaccine to be listed for emergency use by the WHO, a key step that paves the way for it to be used in developing countries. The emergency listing is also needed for the vaccine to be part of the COVAX program, which is designed to ensure equitable access.

At a WHO briefing today, Director-General Tedros Adhanom Ghebreyesus, PhD, said the group's vaccine advisors will meet next week to make recommendations on the vaccine's use. He said COVAX has booked 500 million Johnson & Johnson vaccine doses.

Bruce Aylward, MD, MPH, senior advisor to Tedros, said COVAX officials are working with the company to bring the vaccine into the program as soon as possible, which could be July or earlier.

WHO officials said today that COVAX has so far delivered 29 million doses of the other listed vaccines to 38 countries.

Tedros said officials are still worried about how to meet the massive demand for vaccines and the raw materials needed to make them, which could limit production of both COVID-19 vaccines and those used for childhood immunizations.

"Some countries have imposed legal restrictions on the export of critical supplies. This is putting lives at risk around the world," he said. "We call on all countries not to stockpile supplies that are needed urgently to ramp up production of vaccines."

WHO officials met with industry officials and other stakeholders this week to look at issues and solutions, and Mariangela Simao, MD, MSc, the WHO's assistant director-general for access to medicines and health products, said one possibility is for Johnson & Johnson to expand manufacturing capacity to other countries, similar to how production of the AstraZeneca-Oxford vaccine was expanded in India and South Korea.

In a related development today, the WHO published its new strategy and budget for the ACT Accelerator, which includes COVAX as well as treatments and diagnostic tests. The document shows that $11 billion has been committed so far, with a remaining funding gap of $22.1 billion.

Countries pause AstraZeneca vaccine as precaution

More countries announced temporary suspensions of vaccination with the AstraZeneca-Oxford vaccine, some covering limited batches, following a few reports of blood clots in vaccine recipients in Austria and Denmark.

However, the European Medicines Agency (EMA) said there is no indication that vaccination caused the episodes and that the vaccine's benefits continue to outweigh the risks. It said the number of thromboembolic events in vaccinated people is no higher than that of the general population.

As of Mar 10, the EMA said there were 30 cases of thromboembolic events among close to 5 million people who have received the AstraZeneca-Oxford vaccine in Europe. And it notes that its safety committee is continuing to review all reports related to the vaccine.

At today's WHO briefing, Tedros said the WHO is aware of the reports, which pertain to recipients of two batches of the vaccine, and he emphasized that countries have suspended use as a precaution to allow a full investigation to be finalized. He said the WHO's vaccine safety committee is carefully assessing the reports.

Simao said the WHO's vaccine safety committee expects to release a statement next week when its investigation is complete. She noted that the two batches that raised concerns in some countries were produced in Europe.

Concerns over Brazil's rising surge

WHO officials today aired deep concerns about Brazil's deepening COVID-19 crisis, which has put intensive care unit (ICU) occupancy at 96% in the midwest and south of the country.

Mike Ryan, MD, who leads the group's health emergencies program, said the country's case fatality rate has risen significantly, would could reflect pressure on the healthcare system. Maria Van Kerkhove, PhD, the WHO's technical lead for COVID-19, said initial studies show that the P1 variant that is now dominant in Brazil is more transmissible, with some suggesting that it causes more severe disease.

Tedros said to reverse the steady rises in cases and deaths, the country needs serious measures with clear messages from top government authorities. He also said Brazil's expanding outbreak poses a risk to neighboring countries and beyond.

In other global headlines:

  • Italian health officials tightened restrictions for much of the country to slow its surge, and the country will enter a national lockdown over Easter weekend, according to Reuters. Cases rose 10% this week, fueled by the spread of more transmissible variants.

  • German health officials are acknowledging that a third spike is starting and warned of tough weeks ahead, compounded by a slow start to vaccination due to supply and logistical issues, according to the Washington Post. Elsewhere in Europe, Portugal—one of the first European countries to experience a third surge—is starting to slowly lift its restrictions.

  • The global COVID-19 total today reached 118,860,770 cases with 2,634,724 deaths, according to the Johns Hopkins online dashboard.

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