sunny.png
Wednesday February 24th, 2021 12:41PM

India's quick nod to homegrown COVID-19 vaccine seeds doubt

By The Associated Press
Related Articles
  Contact Editor

NEW DELHI (AP) — As the director of a large hospital in the Indian state that has seen the country's most coronavirus cases, Dr. S.P. Kalantri had been waiting for the day a vaccine would be approved and bring protection not only to his community but also himself.

But now he has his doubts about getting the shots after India took a regulatory shortcut to approve a vaccine by Indian drugmaker Bharat Biotech before late clinical trials showed it was effective in preventing illness from coronavirus infections.

“I’d rather wait and watch,” said Kalantri, who runs a hospital in Maharashtra state's Wardha district.

He's not alone. Several groups and unions representing scientists and doctors have also expressed their concerns over scant evidence of the effectiveness of the vaccine.

Many scientists have said that approving a vaccine without evidence from late trials is risky and a lack of transparency in the approval process could increase vaccine hesitancy in the world’s second-most populated country, where more than 10.4 million coronavirus cases have been reported among the nearly 1.4 billion people.

The homegrown vaccine was one of two that India authorized for emergency use on Jan. 3. The approval for the other — a version of the AstraZeneca vaccine made by world's largest vaccine maker Serum Institute of India — was given on the basis of partial results from studies in Britain and Brazil that suggested it was about 70% effective at preventing illness from coronavirus infection.

Initially, a member of India’s COVID-19 task force said that the Bharat Biotech vaccine would be a “backup.” But on Jan. 5, health officials said it would be given to people after getting their consent and ensuring more frequent follow-ups, suggesting both vaccines will be deployed. It remains unclear as to which states will receive which vaccine and on what basis.

Prime Minister Narendra Modi has touted the vaccines as evidence of India's growing self-reliance due to its protectionist policies.

On Jan. 16 India will start the massive undertaking of inoculating an estimated 30 million doctors, nurses and other front line workers, before attention turns to around 270 million people who are either aged over 50 or have co-morbidities.

China and Russia have also administered vaccines while late clinical trials were still underway. But India, which is the world’s largest manufacturer of vaccines, has drawn criticism for using two different standards — needing efficacy data for one and not the other — for greenlighting the use of the two vaccines as well as a lack of transparency in the process.

The panel of experts that eventually gave the nod to the vaccines met three times. In the first two meetings, on Dec. 30 and Jan. 1, they were dissatisfied with Bharat Biotech's application and asked for more data on its ability to prevent illness from COVID-19, minutes from the meeting show. The AstraZeneca vaccine, meanwhile, was greenlit on Jan. 1.

But on Jan. 2, the experts permitted the restricted use of the Bharat Biotech vaccine as an “abundant precaution” after the company claimed that the vaccine had the potential to target a more contagious variant of the virus found in Britain.

Since its approval, Bharat Biotech’s chairman and managing director Krishna Ella has acknowledged that the vaccine’s effectiveness against the U.K. variant is “only a hypothesis.”

Although minutes from the Jan. 2 meeting maintain that the company presented “updated data,” there isn't any clarity as to what new evidence prompted the experts to change their minds, resulting in the need for “guess work,” said Dr. Anant Bhan, who studies medical ethics and was not on the panel.

Dr. Vineeta Bal, who studies immune systems at India’s National Institute of Immunology, echoed the need for transparent approvals that includes data that confirms efficacy.

“This is a process that Indian government officials are themselves sabotaging,” she said.

India's main opposition Congress party has said that the premature clearance was “unprecedented, inadvisable and risks lives.” That concern was echoed by the health minister of Chattisgarh state, TS Singh Deo, who said the Bharat Biotech vaccine shouldn't be used in the state.

“Rushing into general use before trials are complete will set a precedent where other companies will seek emergency use authorization before completing mandated trials. This may also jeopardize the valuable lives and health of our citizens,” Deo said.

Some have implied that the approval of the vaccine was based on nationalism. After the AstraZeneca vaccine was approved and before the clearance for the Bharat Biotech vaccine was issued, a leader from Modi’s party tweeted that he was shocked to learn that a foreign vaccine had been approved, while an Indian vaccine lay “in the ditch.”

The head of India's drug regulator has declined to comment on the controversy, while the identity of the experts on the panel that approved the vaccines has not been made public.

Balram Bhargava, who heads the Indian Council of Medical Research, the country’s apex medical research body, said the “restricted use” of a vaccine on the basis of data from early clinical trials is legally possible in a pandemic. The body is a co-sponsor of the trials.

Also muddying the waters was a public spat between the top executives of Serum Institute of India and Bharat Biotech in which they each questioned the effectiveness of the other's vaccine. The executives later issued a joint statement saying the events were a “miscommunication and misunderstanding” and that they were focused on the vaccine rollout.

“Such actions do raise doubts in the minds of people and may promote vaccine hesitancy,” said Dr. Shahid Jameel, who studies viruses at India's Ashoka University.

He said that while Bharat Biotech's homegrown vaccine was promising, the approval process needs to be based on hard data and evidence.

“Belief has no value in science,” Jameel said.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

  • Associated Categories: Associated Press (AP), AP Health, AP World News, AP Business, AP Business - Corporate News, AP Business - Industries, AP Business - Health Care
© Copyright 2021 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
Village doctor in Ukraine faces coronavirus challenge
Riding a horse-drawn cart, Dr. Viktoria Mahnych trots along country roads to attend to her patients in several villages nestled in the Carpathian Mountains in western Ukraine
2:20AM ( 11 minutes ago )
India's quick nod to homegrown COVID-19 vaccine seeds doubt
India took a regulatory shortcut for their homegrown vaccine, a move touted by Prime Minister Narendra Modi as a success in India’s self-reliance
2:06AM ( 26 minutes ago )
Records show fervent Trump fans fueled US Capitol takeover
The violent mob that stormed the U.S. Capitol last week was overwhelmingly made up of longtime Trump supporters
1:48AM ( 44 minutes ago )
Associated Press (AP)
China: WHO experts arriving Thursday for virus origins probe
China says a group of experts from the World Health Organization are due to arrive Thursday for an investigation into the origins of the coronavirus pandemic
12:40AM ( 1 hour ago )
The Latest: Scores test positive in China's Hebei province
Chinese health authorities say scores more people have tested positive for coronavirus in Hebei province bordering on the capital Beijing
8:55PM ( 5 hours ago )
The Latest: Japanese Health Ministry finds new virus variant
The Japanese Health Ministry has found a coronavirus variant in people arriving from Brazil that’s different from the ones in Britain and South Africa
7:28PM ( 7 hours ago )
AP Health
EXPLAINER: Why Indonesia's plane safety record is a concern
The crash of a Sriwijaya Air jet carrying 62 people once again turns a microscope on the safety of Indonesia’s aviation industry
12:46AM ( 1 hour ago )
N. Korea's Kim adds title: General secretary of ruling party
North Korean leader Kim Jong Un has been given the new title of general secretary of the ruling Workers’ Party, a designation formerly held by his late father and grandfather
12:07AM ( 2 hours ago )
South Korean diplomat in Iran over seized ship, frozen funds
Iran says a South Korean diplomatic delegation has arrived in the country to negotiate the release of a vessel amid an escalating financial dispute between the countries
9:27PM ( 5 hours ago )
AP World News
Biden faces challenge in guiding American past Trump era
Joe Biden has already been preparing for months to take on a series of historic crises — a pandemic that’s killed at least 373,000 Americans and a sluggish economy that’s left millions jobless
12:20AM ( 2 hours ago )
Asian shares mostly higher on optimism despite pandemic
Asian shares are mostly higher as bullish sentiments stuck to global markets despite continuing signs of economic damage from the pandemic and a new version of the virus was reported in Japan
10:41PM ( 3 hours ago )
The Latest: Browns open 28-0 lead over Steelers
The Cleveland Browns are off to a record-setting start in Pittsburgh
9:14PM ( 5 hours ago )
AP Business
Syria temporarily cuts supplies of fuel to meet shortages
Syria’s petroleum ministry is blaming U.S. sanctions for forcing it to reduce by up to 24% its distribution of fuel and diesel
9:11AM ( 17 hours ago )
Squelched by Twitter, Trump seeks new online megaphone
Though stripped of his Twitter megaphone, President Donald Trump does have alternative options of much smaller reach
11:16PM ( 1 day ago )
After DOJ warning, NCAA to delay vote on compensation rules
The NCAA is set to delay a potential landmark vote on legislation that would permit college athletes to be compensated for their fame for the first time after receiving a warning from the Department of Justice about potential antitrust violations
6:42PM ( 1 day ago )
AP Business - Corporate News
Minister: Massive power outage leaves Pakistan in the dark
Pakistan's energy minister says a major technical fault in the country's power generation and distribution system caused a massive power outage that plunged the country into darkness overnight
1:34AM ( 1 day ago )
New Zealand central bank says data system hacked
New Zealand’s central bank says one of its data systems has been breached by an unidentified hacker who potentially accessed commercially and personally sensitive information
12:23AM ( 1 day ago )
The Latest: Mexico sees record 16,105 new virus cases
Mexico has posted another daily record for newly confirmed coronavirus cases, with 16,105 new infections reported Saturday, and a near-record of 1,135 deaths related to COVID-19 in the latest 24-hour period
10:22PM ( 1 day ago )
AP Business - Industries
The Latest: India planning to start vaccine drive in 1 week
The government of India is planning to kick off a vaccination drive on Jan. 16 to stem COVID-19 in the world’s second-most populous country
9:19AM ( 1 day ago )
Asia Today: China asks residents in 2 cities to stay home
Chinese authorities have asked residents in two cities south of Beijing to stay home for seven days as they try to stamp out a COVID-19 outbreak in which more than 300 people have tested positive in the past week
6:51AM ( 1 day ago )
The Latest: Twitter hides Iranian vaccine conspiracy post
Twitter has hidden a post on the account of Iran’s Supreme Leader Ayatollah Ali Khamenei on a coronavirus vaccine conspiracy theory
6:01AM ( 1 day ago )
AP Business - Health Care
Village doctor in Ukraine faces coronavirus challenge
Riding a horse-drawn cart, Dr. Viktoria Mahnych trots along country roads to attend to her patients in several villages nestled in the Carpathian Mountains in western Ukraine
2:20AM ( 11 minutes ago )
Asia Today: Virus rules tightened in province near Beijing
Chinese health authorities say scores more people have tested positive for coronavirus in Hebei province bordering on the capital Beijing
1:43AM ( 49 minutes ago )
Saar, longtime Netanyahu ally, emerges as his top challenger
Gideon Saar has for years been one of Prime Minister Benjamin Netanyahu’s most loyal and vocal supporters, serving as Cabinet secretary and government minister
1:35AM ( 57 minutes ago )
Capitol police were overrun, little defense against rioters
Despite ample warnings about pro-Trump demonstrations in Washington, U.S. Capitol Police did not bolster staffing on Wednesday and made no preparations for the possibility that the planned protests could escalate into massive violent riots, according to several people briefed on law enforcement’s response
1:31AM ( 1 hour ago )
Pelosi says House will impeach Trump, pushes VP to oust him
House Speaker Nancy Pelosi says the House will proceed with legislation to impeach President Donald Trump as she pushes the vice president to invoke constitutional authority to force him out
1:21AM ( 1 hour ago )