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.
Also read: India OKs AstraZeneca, locally-made COVID-19 vaccines
“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.
Also read: India planning to start vaccine drive in 1 week
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.
Also read: Bharat Biotech to begin phase-3 trials of Covid vaccine soon
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.
Also read: India tests vaccine delivery system with nationwide trial
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.
Also read:Studies suggest AstraZeneca COVID-19 vaccine safe, effective
“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.
A Chinese official on Monday denied Beijing has imposed coercive birth control measures among Muslim minority women, following an outcry over a tweet by the Chinese Embassy in Washington claiming that government polices had freed women of the Uighur ethnic group from being “baby-making machines.”
Xu Guixiang, a deputy spokesperson for the Xinjiang regional government, told reporters Monday that birth control decisions were made of the person’s own free will and that “no organization or individual can interfere.”
Also read: U.S. bill on Xinjiang interferes in China's internal affairs: Experts
“The growth rate of the Uighur population is not only higher than that of the whole Xinjiang population, but also higher than that of the minority population, and more significantly higher than that of the (Chinese majority) Han population,” Xu said. “As for the so-called forcing ethnic minority women in Xinjiang to wear IUDs, or undergo tubal ligations or abortions, it is even more malign.”
An Associated Press investigation in June found that the Chinese government was forcing draconian birth control measures on Uighurs, Kazakhs, and other ethnic minorities in Xinjiang, including IUD fittings, contraceptives, and even abortions and sterilizations.
Also read: Rights abuses: UK accuses China over Uighurs
The measures are backed by the threat of detention, with parents with three or more children swept into camps and prisons if they’re unable to pay massive fines. As a result, the birth rate in Xinjiang’s minority regions plummeted by over 60% in just three years, even as Beijing eases birth restrictions on the Han population ahead of a looming demographic crisis.
Twitter took down the Chinese Embassy’s Jan. 7 tweet following protests by groups that accuse Beijing of seeking to eradicate Uighur culture. Users complained the tweet was a violation of rules set by Twitter, which is blocked in China along with Facebook and other American social media platforms.
“China’s fascist government is now openly admitting and celebrating its use of concentration camps, forced labor, forced sterilizations and abortions, and other forms of torture to eliminate an ethnic and religious minority,” Nihad Awad, national executive director of The Council on American-Islamic Relations, said in an emailed statement.
China has been waging a years-long campaign against what it calls terrorism and religious fanaticism in Xinjiang and the embassy’s tweet referenced those polices, saying: “Study shows that in the process of eradicating extremism, the minds of Uygur women in Xinjiang were emancipated and gender equality and reproductive health were promoted, making them no longer baby-making machines.”
Also read: Uighurs: China dismisses Pope's criticism as 'groundless'
The tweet cited a study by Li Xiaoxia, a Xinjiang Academy of Social Sciences researcher who has asserted that the birth control measures in Xinjiang are voluntary.
Li’s papers in past years laid the theoretical foundations for justifying mass birth control measures. In one 2017 paper, Li said having many children was a sign of “religious extremism and ethnic separatism.” Li worried that predominantly minority districts were breeding grounds for terrorism, calling it “a big political risk.”
Also read: China's Uighurs trapped in factory toiling for tech titans
Monday’s news conference was the latest attempt by Beijing to deflect rising international criticism over its policies in Xinjiang, particularly over alleged forced labor and the detention of more than 1 million Uighurs, Kazakhs and others in prison-like centers for political indoctrination. China says the centers are intended to combat extremism and teach job skills, but former residents and rights groups say they target Islam and minority languages and culture.
Elijan Anayat, another regional government spokesperson, said all those at the centers had “graduated” as of October 2019, countering reports that China continues to expand the system.
Also read: The man behind China's detention of 1 million Muslims
“With the help of the government, they have achieved stable employment, improved the quality of life and lived a normal life,” Anayat said. “At present, there is no education and training center in Xinjiang.”
North Korean leader Kim Jong Un was given the title of general secretary of the ruling Workers’ Party formerly held by his late father and grandfather, state media reported Monday, in a move apparently aimed at bolstering his authority amid growing economic challenges.
The designation was North Korea’s latest step taken during its first ruling party congress since 2016.
During the meeting, Kim also vowed to build more sophisticated nuclear weapons, disclosed economic developmental goals and reshuffled party officials. But observers doubt whether such moves can offer North Korea any substantial solutions to difficulties that include coronavirus-related economic shocks, natural disasters and persistent U.S.-led sanctions.
Also Read: North Korea threatens to build more nukes, cites US hostility
The congress announced Kim’s new title during the sixth day of the meeting on Sunday. A congress statement said Kim “has gloriously realized the historic mission to complete the country’s nuclear build-up plan,” according to the official Korean Central News Agency.
Kim already was the party’s top leader. During a 2016 party congress, he was named party chairman and before that had led the party with the title of first secretary. But general secretary has important symbolism in the country led by dynastic rule since it was the title held by his father, Kim Jong Il, and grandfather, Kim Il Sung.
Also Read: North Korea flies out foreign diplomats amid virus fight
When Kim Jong Un inherited the country’s leadership upon his father’s death in late 2011, some foreign experts initially questioned his grip on power. But Kim, who turned 37 on Friday, has consolidated his power through high-profile executions and purges that removed potential rivals. His other top jobs include chairman of the State Affairs Commission and supreme commander of North Korea’s 1.2 million-member military, along with the top party post.
Cheong Seong-Chang, a fellow at the Wilson Center’s Asia Program, said Kim likely restored the old general secretary title after determining that it would further benefit his dictatorship. Under the previous title systems, Cheong said that there were too many chairmen and vice chairmen at various levels, and that authorities appeared to have thought it wasn’t helpful for Kim’s authority.
During congress meetings last week, Kim labeled the U.S. as “our foremost principal enemy” and disclosed a list of high-tech nuclear weapons systems under development to cope with what he called intensifying American hostility. He said the fate of relations between Pyongyang and Washington depend on whether the U.S. abandons its hostile policy.
Also Read: North Korea fires missiles into sea, criticized by South
Kim acknowledged that a previous five-year economic development plan failed and disclosed a new economic plan that focuses on building a stronger self-supporting economy and reducing reliance on imports. He said the new plans would include more investments in the metal and chemical industries, and increasing the production of consumer goods.
Kim’s latest nuclear threats were likely meant to pressure President-elect Joe Biden to resume diplomacy and make concessions after he takes office next week. But some experts say Biden, who has criticized Kim’s made-for-camera summits with President Donald Trump, won’t do so. They say Kim’s new economic plan lacks substance, and that much of North Korea’s chronic economic difficulties are a result of its decades-long mismanagement, self-imposed isolation and U.S.-led sanctions imposed because of his nuclear program.
Also Read: North Korea lifts lockdown in city, rejects flood, virus aid
“There was no willingness demonstrated to take denuclearization steps for sanctions relief,” said Leif-Eric Easley, a professor at Ewha University in Seoul. “His new economic plan doesn’t look that new, as it continues the fiction of self-reliant production to advance North Korean-style socialism.”
“It’s one thing to present an ambitious list of economic and military goals, but quite another to pay for and implement them,” he said.
Kim has pushed to simultaneously achieve economic growth and the expansion of his nuclear deterrent. After claiming to have achieved the ability to strike the U.S. mainland with nuclear weapons, he launched high-stakes summits with Trump in 2018 to win sanctions relief and revive the economy. But the diplomacy collapsed the following year after Trump rejected Kim’s offer to get extensive sanctions relief in return for a limited denuclearization step.
Also Read: North Korea unveils new weapons at military parade
South Korea’s military said it had obtained intelligence showing North Korea staged a military parade at a Pyongyang square on Sunday night. A statement from the Joint Chiefs of Staff on Monday said it was checking whether it was an actual parade or a rehearsal. The parade likely featured new weapons systems in a show of force against the incoming Biden administration, observers said.
Meanwhile, among the notable personnel changes announced Monday was the name of Kim Jong Un’s influential sister, Kim Yo Jong, missing from a new lineup for the party’s powerful Politburo, where she had served as an alternate member since last year. She retained her membership at the party’s Central Committee, also a high-level body.
Some observers earlier predicted she would be promoted to a full member of the bureau. It wasn’t immediately clear why the 32-year-old lost her Politburo post. But given her direct lineage to the ruling Kim family, some experts caution against speculating her political clout has diminished. Last year, state media said she was in charge of relations with rival South Korea as well.
Authorities said they determined the location of the crash site and black boxes of a Boeing 737-500 on Sunday, a day after the aircraft crashed into the Java Sea with 62 people on board shortly after taking off from Indonesia’s capital.
The head of Indonesia’s National Search and Rescue Agency, Bagus Puruhito, said officials believe they identified the location of the flight data recorder and cockpit voice recorder — the so-called black boxes — because emergency signals transmitted by the devices were detected by a navy ship’s sonar system.
“Hopefully we can lift the black boxes in short time to determine the cause of the crash,” military chief Hadi Tjahjanto said.
Earlier Sunday, search and rescue operations resulted in parts of the plane being found in the sea at a depth of 23 meters (75 feet), leading rescuers to continue searching the area.
“We received reports from the diver team that the visibility in the water is good and clear, allowing the discovery of some parts of the plane,” Tjahjanto said in a statement. “We are sure that is the point where the plane crashed.”
He said the objects found included broken pieces of fuselage with aircraft registration parts.
Earlier, rescuers pulled out body parts, pieces of children’s clothing and scraps of metal from the surface.
The break in the search for Sriwijaya Air Flight 182 came after the navy ship’s sonar equipment detected a signal from the aircraft at a location that fit the coordinates from the last contact made by the pilots before the plane disappeared Saturday afternoon, Tjahjanto said.
The plane was en route from Jakarta to Pontianak, the capital of West Kalimantan province on Indonesia’s Borneo island, on a flight that was expected to take around 90 minutes.
It was still unclear what caused it to crash. There was no sign of survivors.
Also read:Airline now says 1 missing after Pacific lagoon plane crash
“I represent the government and all Indonesians in expressing my deep condolences for this tragedy,” Indonesian President Joko Widodo said.
“We are doing our best to save the victims. We pray together so that the victims can be found,” he said, adding that he had asked the National Transport Safety Committee to conduct an investigation.
Fishermen in the area between Lancang and Laki islands, part of an archipelago around Thousand Islands north of Jakarta’s coast, reported hearing an explosion around 2:30 p.m. Saturday.
“We heard something explode — we thought it was a bomb or a tsunami since after that we saw a big splash from the water,” Solihin, who goes by one name, said by phone.
“It was raining heavily and the weather was so bad, so it was difficult to see around clearly,” Solihin said. “But we saw the splash and a big wave after the loud sound. We were very shocked and saw the plane debris and the fuel around our boat.”
Also read:Indonesian airliner loses contact on domestic flight
Transportation Minister Budi Karya Sumadi said the flight was delayed for an hour before it took off at 2:36 p.m. It disappeared from radar four minutes later, after the pilot contacted air traffic control to ascend to an altitude of 29,000 feet (8,839 meters), he said.
There were 62 people on board, all of them Indonesian nationals, including three babies and seven other children. The plane was carrying 50 passengers, six working crew members and six other crew for another flight.
“Our thoughts are with the crew, passengers, and their families,” Boeing said in a statement. “We are in contact with our airline customer and stand ready to support them during this difficult time.”
Authorities established two crisis centers, one at Soekarno-Hatta International Airport, where the plane departed from, and one at port. Families gathered to wait for news about their loved ones.
Also read:Body parts, debris found after Indonesia plane crash
On social media, people began circulating the flight manifesto with photos and videos of those who were listed as passengers. One video shows a woman with her children waving goodbye while walking through the airport.
Sriwijaya Air president director Jefferson Irwin Jauwena said the plane, which was 26 years old and previously used by airlines in the United States, was airworthy. He told reporters Saturday that the plane had previously flown to Pontianak and Pangkal Pinang city on the same day.
He said the plane was delayed due to bad weather, not because of any mechanical problems.
Indonesia, the world’s largest archipelago nation, with more than 260 million people, has been plagued by transportation accidents on land, sea and air because of overcrowding on ferries, aging infrastructure and poorly enforced safety standards.
Also read:Indonesia jet carrying 62 goes missing on domestic flight
In October 2018, a Boeing 737 MAX 8 jet operated by Lion Air plunged into the Java Sea just minutes after taking off from Jakarta, killing all 189 people on board. The plane involved in Saturday’s disaster did not have the automated flight-control system that played a role in the Lion Air crash and another crash of a 737 MAX 8 jet in Ethiopia five months later, leading to the grounding of the MAX 8 for 20 months.
The Lion Air crash was Indonesia’s worst airline disaster since 1997, when 234 people were killed on a Garuda airlines flight near Medan on Sumatra island. In December 2014, an AirAsia flight from the Indonesian city of Surabaya to Singapore plunged into the sea, killing 162 people.
Also read:Indonesia plane goes missing after take-off
Sriwijaya Air has had only minor incidents in the past, though a farmer was killed in 2008 when a plane went off the runway while landing due to a hydraulic issue.
The United States banned Indonesian carriers from operating in the country in 2007, but reversed the decision in 2016, citing improvements in compliance with international aviation standards. The European Union has previously had similar bans, lifting them in June 2018.
Indonesian rescuers pulled out body parts, pieces of clothing and scraps of metal from the Java Sea early Sunday morning, a day after a Boeing 737-500 with 62 people onboard crashed shortly after takeoff from Jakarta, officials said.
Officials were hopeful they were honing in on the wreckage of Sriwijaya Air Flight 182 after sonar equipment detected a signal from the aircraft.
Transportation Minister Budi Karya Sumadi told reporters that authorities have launched massive search efforts after identifying “the possible location of the crash site.”
Also read: Indonesia jet carrying 62 goes missing on domestic flight
“These pieces were found by the SAR team between Lancang Island and Laki Island,” National Search and Rescue Agency Bagus Puruhito in a statement.
Indonesian military chief Air Chief Marshal Hadi Tjahjanto said teams on the Rigel navy ship equipped with a remote-operated vehicle had detected a signal from the aircraft, which fit the coordinates from the last contact made by the pilots before the plane went missing.
Also read: 2 U.S. airmen killed in Afghanistan plane crash: Pentagon
“We have immediately deployed our divers from navy’s elite unit to determine the finding to evacuate the victims,” Tjahjanto said.
More than 12 hours since the Boeing plane operated by the Indonesian airline lost contact, little is known about what caused the crash.
Also read: Firefighting plane crashes in Australia, killing 3 Americans
Fishermen in the area around Thousand Islands, a chain of islands north of Jakarta’s coast, reported hearing an explosion around 2:30 p.m. Saturday.
“We heard something explode, we thought it was a bomb or a tsunami since after that we saw the big splash from the water,” fisherman Solihin, who goes by one name, told The Associated Press by phone.
Also read: Bodies of 11 Ukrainians killed in Iran plane crash sent home
“It was raining heavily and the weather was so bad. So it is difficult to see around clearly. But we can see the splash and a big wave after the sounds. We were very shocked and directly saw the plane debris and the fuel around our boat.”
Sumadi said Flight SJ182 was delayed for an hour before it took off at 2:36 p.m. It disappeared from radar four minutes later, after the pilot contacted air traffic control to ascend to an altitude of 29,000 feet (8,839 meters), he said.
There were 62 people on board, including seven children and three babies.
Also read: At least 63 Canadians dead in Iran plane crash
“We are aware of media reports from Jakarta regarding Sriwijaya Air flight SJ-182,” Boeing said in a statement. “Our thoughts are with the crew, passengers, and their families. We are in contact with our airline customer and stand ready to support them during this difficult time.”
Authorities established two crisis centers, one at airport and one at port. Families gathered to wait for news of loved ones.
On social media, people began circulating the flight manifesto with photos and videos of those who were listed as passengers. One video shows a woman with her children waving goodbye while walking through the airport.
Sriwijaya Air President Director Jefferson Irwin Jauwena said the plane, which is 26 years old and previously used by airlines in the United States, was airworthy. He told reporters Saturday that the plane had previously flown to Pontianak and Pangkal Pinang city on the same day.
“Maintenance report said everything went well and airworthy,” Jauwena told a news conference. He said the plane was delayed due to bad weather, not because of any damage.
Indonesia, the world’s largest archipelago nation, with more than 260 million people, has been plagued by transportation accidents on land, sea and air because of overcrowding on ferries, aging infrastructure and poorly enforced safety standards.
In October 2018, a Boeing 737 MAX 8 jet operated by Lion Air plunged into the Java Sea just minutes after taking off from Jakarta, killing all 189 people on board. The plane involved in Saturday’s incident did not have the automated flight-control system that played a role in the Lion Air crash and another crash of a 737 MAX 8 jet in Ethiopia five months later, leading to the grounding of the MAX 8 for 20 months.
The Lion Air crash was Indonesia’s worst airline disaster since 1997, when 234 people were killed on a Garuda airlines flight near Medan on Sumatra island. In December 2014, an AirAsia flight from the Indonesian city of Surabaya to Singapore plunged into the sea, killing 162 people.
Sriwijaya Air has only has several minor incidents in the past, though a farmer was killed in 2008 when landing plane went off runway due to a hydraulic issue.
The United States banned Indonesian carriers from operating in the country in 2007, but reversed the decision in 2016, citing improvements in compliance with international aviation standards. The European Union has previously had similar bans, lifting them in June 2018.