J&J adds to COVID-19 vaccine armory with 66% efficacy in global trial

The first single-shot vaccine, made by Janssen, appears 66% effective overall at preventing moderate to severe COVID-19. It was more protective against severe symptoms, 85%. (AP)
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Updated 29 January 2021
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J&J adds to COVID-19 vaccine armory with 66% efficacy in global trial

  • J&J will seek emergency use authorization in U.S. next week
  • The pharmaceutical giant has said it plans to deliver 1 billion doses in 2021

LONDON: Johnson & Johnson said on Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a large global trial against multiple variants which will give health officials another weapon to tackle the coronavirus.
In the trial of nearly 44,000 volunteers, the level of protection against moderate and severe COVID-19 varied from 72% in the United States, to 66% in Latin America and just 57% in South Africa, from where a worrying variant has spread.
A high bar has been set by two authorized vaccines from Pfizer/BioNTech and Moderna, which were around 95% effective in preventing symptomatic illness in pivotal trials when given in two doses.
Those trials, however, were conducted mainly in the United States and before new variants emerged.
The top US infectious disease specialist Anthony Fauci said the variations in effectiveness around the world underlined the need to vaccinate as many people as quickly as possible to prevent new variants from emerging.
“It’s really a wake up call for us to be nimble and to be able to adjust as this virus will continue for certain to evolve,” Fauci said.
J&J’s main goal was the prevention of moderate to severe COVID-19, and the vaccine was 85% effective in stopping severe disease and preventing hospitalization across all geographies and against multiple variants 28 days after immunization.
That “will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19,” Paul Stoffels, J&J’s chief scientific officer, said of the results, which were based on 468 symptomatic cases.
J&J plans to seek emergency use authorization from the US Food and Drug Administration next week. It has said it plans to deliver 1 billion doses in 2021 and will produce the vaccine in the United States, Europe, South Africa and India.
Public health officials are counting on the J&J vaccine to increase much-needed supply and simplify immunization in the United States, which has a deal to buy 100 million doses of J&J’s vaccine and an option for an additional 200 million.
J&J said the vaccine would be ready immediately upon emergency approval, but Stoffels declined to say how many doses.
“Right now, any protection and additional vaccine is great. The key is not only overall efficacy but specifically efficacy against severe disease, hospitalization, and death,” Walid Gellad, a health policy associate professor at the University of Pittsburgh, said.
Michael Breen, Director of Infectious Diseases and Ophthalmology at research firm GlobalData said “Most countries are still desperate to get their hands on doses, regardless of whether or not the vaccine is considered highly effective. Moderately effective will do just fine for now.”
None of the vaccine recipients in the J&J trial died from COVID-19, compared with 5 in the placebo group, the National Institutes of Health said. Three deaths in the vaccine group overall, but none were determined to be from the virus. That compares with 16 deaths overall in the placebo arm, it added.
Unlike the Pfizer and Moderna vaccines, J&J’s does not require a second shot weeks after the first or need to be kept frozen, making it a strong candidate for use in parts of the world where transportation and cold storage are an issue.

SOUTH AFRICAN VARIANT
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 efficacy.
“What we are learning is there is different efficacy 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 at preventing severe disease. In the South Africa portion of the trial, 95% of cases were infections with the South African variant.
“I am overwhelmed by the fact that this vaccine protected against severe disease even in South Africa,” said Glenda Gray, the joint lead investigator of the South African vaccine trial.
Gray, who is the chief executive of the South African Medical Research Council, said this is by far the best vaccine for South Africa to fight the mutant strain and can prevent a large number of hospitalizations and deaths.
A mid-stage trial of a Novovax coronavirus vaccine in South Africa also showed lower efficacy, proving to be 60% effective among volunteers who didn’t have HIV. In a separate, late-stage trial in Britain it was 89.3% effective.
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. Slightly more than a third of the volunteers were over 60.
J&J’s vaccine uses a common cold virus to introduce coronavirus proteins into cells in the body and trigger an immune response, whereas the Pfizer/BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA).


Bangladesh mourns Khaleda Zia, its first woman prime minister

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Bangladesh mourns Khaleda Zia, its first woman prime minister

  • Ousted ex-premier Sheikh Hasina, who imprisoned Zia in 2018, offers condolences on her death
  • Zia’s rivalry with Hasina, both multiple-term PMs, shaped Bangladeshi politics for a generation

DHAKA: Bangladesh declared three days of state mourning on Tuesday for Khaleda Zia, its first female prime minister and one of the key figures on the county’s political scene over the past four decades.

Zia entered public life as Bangladesh’s first lady when her husband, Ziaur Rahman, a 1971 Liberation War hero, became president in 1977.

Four years later, when her husband was assassinated, she took over the helm of his Bangladesh Nationalist Party and, following the 1982 military coup led by Hussain Muhammad Ershad, was at the forefront of the pro-democracy movement.

Arrested several times during protests against Ershad’s rule, she first rose to power following the victory of the BNP in the 1991 general election, becoming the second woman prime minister of a predominantly Muslim nation, after Pakistan’s Benazir Bhutto.

Zia also served as a prime minister of a short-lived government of 1996 and came to power again for a full five-year term in 2001.

She passed away at the age of 80 on Tuesday morning at a hospital in Dhaka after a long illness.

She was a “symbol of the democratic movement” and with her death “the nation has lost a great guardian,” Bangladesh’s interim leader Muhammad Yunus said in a condolence statement, as the government announced the mourning period.

“Khaleda Zia was the three-time prime minister of Bangladesh and the country’s first female prime minister. ... Her role against President Ershad, an army chief who assumed the presidency through a coup, also made her a significant figure in the country’s politics,” Prof. Amena Mohsin, a political scientist, told Arab News.

“She was a housewife when she came into politics. At that time, she just lost her husband, but it’s not that she began politics under the shadow of her husband, president Ziaur Rahman. She outgrew her husband and built her own position.”

For a generation, Bangladeshi politics was shaped by Zia’s rivalry with Sheikh Hasina, who has served as prime minister for four terms.

Both carried the legacy of the Liberation War — Zia through her husband, and Hasina through her father, Sheikh Mujibur Rahman, widely known as the “Father of the Nation,” who served as the country’s first president until his assassination in 1975.

During Hasina’s rule, Zia was convicted in corruption cases and imprisoned in 2018. From 2020, she was placed under house arrest and freed only last year, after a mass student-led uprising, known as the July Revolution, ousted Hasina, who fled to India.

In November, Hasina was sentenced to death in absentia for her deadly crackdown on student protesters and remains in self-exile.

Unlike Hasina, Zia never left Bangladesh.

“She never left the country and countrymen, and she said that Bangladesh was her only address. Ultimately, it proved true,” Mohsin said.

“Many people admire Khaleda Zia for her uncompromising stance in politics. It’s true that she was uncompromising.”

On the social media of Hasina’s Awami League party, the ousted leader also offered condolences to Zia’s family, saying that her death has caused an “irreparable loss to the current politics of Bangladesh” and the BNP leadership.

The party’s chairmanship was assumed by Zia’s eldest son, Tarique Rahman, who returned to Dhaka just last week after more than 17 years in exile.

He had been living in London since 2008, when he faced multiple convictions, including an alleged plot to assassinate Hasina. Bangladeshi courts acquitted him only recently, following Hasina’s removal from office, making his return legally possible.

He is currently a leading contender for prime minister in February’s general elections.

“We knew it for many years that Tarique Rahman would assume his current position at some point,” Mohsin said.

“He should uphold the spirit of the July Revolution of 2024, including the right to freedom of expression, a free and fair environment for democratic practices, and more.”