J&J Vaccine Adds to COVID-19 Arsenal, Includes South African Variant

(Reuters) – Johnson & Johnson said on Friday its single-dose vaccine was 66% effective in preventing COVID-19 in a large global trial against several variants, giving health officials another weapon to fight the pandemic .

In the trial of nearly 44,000 volunteers, the level of protection against moderate and severe COVID-19 ranged from 72% in the United States, to 66% in Latin America, and only 57% in South Africa, hence a disturbing variant has spread.

Data showed the vaccine’s effect on the South African variant was diminished compared to the unmodified virus, but infectious disease and public health experts said it could still help contain the spread of the virus and to prevent deaths.

Novavax mid-term test data on Thursday also documented lower efficacy in South Africa.

The competing injections of Pfizer / BioNTech and Moderna were both approximately 95% effective in preventing symptomatic disease in the pivotal trials when given in two doses.

These trials were conducted primarily in the United States and before the emergence of new variants. This means the world is racing against the clock and with limited supplies to vaccinate as many people as possible, and quickly, to prevent outbreaks of the virus.

COVID-19 is increasing in 37 countries and infections have exceeded 101 million worldwide.

Anthony Fauci, the US infectious disease specialist, said the world needs to vaccinate quickly to try to forestall these changes in the virus.

“It’s really a wake-up call for us to be nimble and able to adapt as this virus will continue to evolve for sure,” Fauci said.

J & J’s primary goal was the prevention of moderate to severe COVID-19, and the vaccine was 85% effective in stopping severe illness and preventing hospitalization in all geographies and against multiple variants 28 days after vaccination.

This will “potentially protect hundreds of millions of people from the serious and fatal consequences of COVID-19,” said Paul Stoffels, scientific director of J&J.

J&J shares were down 4% to $ 162.7 at 5:00 p.m. GMT, with some Wall Street analysts claiming its vaccine’s effectiveness was lower than that of its rivals. Moderna stock gained 8% to $ 172.80.

APPLICATION FOR APPROVAL

J&J plans to apply for emergency use authorization from the United States Food and Drug Administration next week and will follow up with the European Union and the rest of the world soon.

It has announced plans to deliver 1 billion doses of the vaccine, which it will manufacture in the United States, Europe, South Africa and India, in 2021.

Public health officials are counting on him to increase much-needed supplies and simplify vaccination in the United States, which has reached a deal to purchase 100 million doses of J&J vaccine and an option for another 200 million.

J&J said the vaccine would be ready immediately after emergency approval, but Stoffels declined to say how many doses.

“The key is not just overall effectiveness, but specifically effectiveness against serious illness, hospitalization and death,” said Walid Gellad, associate professor of health policy at the University of Pittsburgh.

J & J’s vaccine uses a common cold virus to introduce coronavirus proteins into cells and trigger an immune response, while the Pfizer / BioNTech and Moderna vaccines use a new technology called messenger RNA.

Unlike these vaccines, J & J’s does not require a second injection a few weeks after the first or should not be stored frozen, making it an excellent candidate for use in areas of the world where transport and cold storage pose problems.

“Most countries are still desperate to get their hands on the doses, whether the vaccine is considered highly effective or not. Moderately effective will do very well for now, ”said Michael Breen, director of infectious diseases and ophthalmology at research firm GlobalData.

‘SUBMERGED’

Several studies have emerged this month showing that a South African variant has mutated in areas of the virus that are key targets of vaccines, reducing their effectiveness.

“What we are learning is that there is different efficiency in different parts of the world,” Stoffels told Reuters.

In a sub-study of 6,000 volunteers in South Africa, Stoffels said the J&J vaccine was 89% effective in preventing serious illness. In the South African part of the trial, 95% of cases were infections with the South African variant.

“I am overwhelmed that this vaccine protects against serious disease even in South Africa,” said Glenda Gray, co-principal investigator of the South African vaccine trial.

In the J&J trial, which was conducted in eight countries, 44% of participants were from the United States, 41% from Central and South America, and 15% from South Africa. Just over a third of the volunteers were over 60 years old.