Cincunri Sakia

Senin, 04 Januari 2021

Covaxin: Concern over 'rushed' approval for India Covid jab - BBC News

Experts have raised concerns over India's emergency approval of a locally-produced coronavirus vaccine before the completion of trials.

On Sunday, Delhi approved the vaccine - known as Covaxin - as well as the global AstraZeneca Oxford jab, which is also being manufactured in India.

Prime Minister Narendra Modi touted the approval as a "game changer" but health experts warn it was rushed.

Health watchdog All India Drug Action Network said it was "shocked".

It said that there were "intense concerns arising from the absence of the efficacy data" as well a lack of transparency that would "raise more questions than answers and likely will not reinforce faith in our scientific decision making bodies".

The statement came after India's Drugs Controller General, VG Somani, insisted Covaxin was "safe and provides a robust immune response".

He added the vaccines had been approved for restricted use in "public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains".

"The vaccines are 100% safe," he said, adding that side effects such as "mild fever, pain and allergy are common for every vaccine".

The All India Drug Action Network, however, said it was "baffled to understand the scientific logic" to approve "an incompletely studied vaccine".

One of India's most eminent medical experts, Dr Gagandeep Kang, told the Times of India newspaper that she had "not seen anything like this before". She added that "there is absolutely no efficacy data that has been presented or published".

Even social media users were quick to point out that approving the vaccine before trials were complete was a matter of concern irrespective of how safe or effective the vaccine eventually turned out to be.

Bharat Biotech’s Covaxin might turn out to be best Vaccine in world. That’s not the Point. Concern is that it has been approved without Peer Reviewed Phase 1-2 results and incomplete Phase 3 Trial. Govt saying it is 110% safe is not Data and “Give it a Chance” is not strategy
— Joy (@Joydas) January 3, 2021

The BBC is not responsible for the content of external sites.View original tweet on Twitter

A matter of trust

Vikas Pandey, BBC News, Delhi

Many scientists and opposition politicians have raised questions over what they say is the hasty authorisation of Covaxin, an Indian-made vaccine by local pharmaceutical firm Bharat Biotech.

The company has developed the vaccine with the state-run Indian Council of Medical Research - and the effort has been touted as an example of India's might in vaccine development and production.

Regulators say the vaccine is safe and effective. The firm says phase 1 and phase 2 trials have shown good results.

But scientists say that the government's decision not to release data on the vaccine's efficacy for peer review has raised concerns.

Mr Modi has welcomed the approval, saying Covaxin is a shining example of his ambitious Atmnirbhar (self-reliance) India campaign.

But experts worry that questions over the approval process don't bode well for the campaign. And there could be deeper issues. Many believe that the government needs to be more transparent about the authorisation process because the success of the Covid-19 vaccine programme depends on public trust.

The emergency authorisation also sparked a fierce debate on Indian Twitter on Sunday night between ministers and opposition leaders.

India's health minister Dr Harsh Vardhan called out opposition leaders for failing to "applaud" the country's "prowess" in locally producing a vaccine.

Members of the main opposition Congress party, Shashi Tharoor and Jairam Ramesh, and former chief minister of Uttar Pradesh state, Akhilesh Yadav, were among those who raised concerns about the manner in which Covaxin was approved.

This is all we are saying. Of course we will be proud if the vaccine turns out to work effectively. But offering it before Phase3 clinical trials have proven efficacy is a violation of every scientific protocol &unheard of in the world. Jingoism is no substitute for common sense. https://t.co/aRlU8TvYHT
— Shashi Tharoor (@ShashiTharoor) January 4, 2021

The BBC is not responsible for the content of external sites.View original tweet on Twitter

Disgraceful for anyone to politicise such a critical issue.
Sh @ShashiTharoor, Sh @yadavakhilesh & Sh @Jairam_Ramesh don't try to discredit well laid out science-backed protocols followed for approving #COVID19vaccines
Wake up & realise you are only discrediting yourselves !
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021

The BBC is not responsible for the content of external sites.View original tweet on Twitter

The approval comes as India gears up to vaccinate its population of more than 1.3 billon people. Amid fears that richer countries are buying up much of the vaccine supply, India too appears to be stockpiling vaccines.

In an interview with the Associated Press, Adar Poonawalla, whose Serum Institute of India is manufacturing the AstraZeneca Oxford vaccine, said the jab was given emergency authorisation on the condition that it would not be exported outside India.

Mr Poonawalla said his company, the world's largest vaccine maker, was also not allowed to sell the shot in the private market.

India plans to vaccinate some 300 million people on a priority list by August.

It has recorded the second-highest number of infections in the world, with more than 10.3 million confirmed cases to date. Nearly 150,000 people have died.

Both vaccines approved on Sunday can be transported and stored at normal refrigeration temperatures.

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2021-01-04 06:29:00Z
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Minggu, 03 Januari 2021

Nora Quoirin: Malaysia coroner rules out involvement of others in death of teenager - Sky News

A coroner in Malaysia has ruled the death of British teenager Nora Quoirin was most likely a misadventure that did not involve other people.

The 15-year-old from Balham, southwest London, vanished from a hotel in August 2019.

Rescue teams searched for 10 days before her body was found by a stream just over a mile and a half (2.5km) from where she was last seen at the Dusun eco-resort in southern Negeri Sembilan.

Reading her verdict to a virtual hearing watched by Nora's parents, coroner Maimoonah Aid said: "After hearing all the relevant evidence, I rule that there was no one involved in the death of Nora and it is more probable than not that she died by misadventure i.e. she had gone out of the Sora House on her own and subsequently got lost in the abandoned palm oil plantations."

She said it would be a breach of her duty to speculate on third-party involvement without any evidence.

Police previously told the inquest that there was no evidence of criminal activity, suggesting Nora had climbed out of a window and wandered off, but her mother said she believed someone had taken her.

Meabh Quoirin said her daughter was born with holoprosencephaly, a disorder which affects brain development leaving Nora with learning disabilities and struggling with balance and coordination.

She said it was near-impossible for her daughter to push open and climb out of a window in the cottage.

A broken latch meant that it wasn't locked.

"I have a number of very precise reasons to believe that my daughter was kidnapped. How or why, I'm not qualified to say," she told the coroner.

The Quoirins, who have lived in London for 20 years, landed in Kuala Lumpur on 3 August and travelled around an hour to the Dusun resort.

Around 5pm that evening, the family went for a walk around the grounds and told the court they were all in bed by around 10pm.

During the night both Meabh, who is Irish and Nora's father, Sebastien, a Frenchman, said they heard "muffled whispering" inside the house but were half asleep so didn't investigate further.

The following morning when Sebastien went to wake the children, Nora was missing.

"He said words to the effect of 'Nora's not here Meabh, can you see her?' And I immediately, immediately panicked," Mrs Quoirin said as she gave evidence.

A huge search effort ensued, with officials and volunteers scouring the nearby jungle.

On 12 August, the family offered a £10,000 reward for information.

"Nora is our first child. She has been vulnerable since the day she was born, she is so precious to us and our hearts are breaking," Meabh Quoirin said in a statement announcing the reward.

The following day, a local villager called Magendran told Sky News he joined volunteers in the hunt.

He was with them when they found Nora's body.

"We started the search from here and walked all the way down the ravine to a small stream. We stopped to rest for a while and saw some small shacks around, old ones," he said.

"From there, we split up into different teams to search the area and followed the stream, and from there we found the body."

A UK pathologist, who carried out a second post-mortem, told the inquest he agreed Nora had died from intestinal bleeding due to stress and starvation.

Forensic pathologist, Nathaniel Cary said he found no positive evidence the teenager had been sexually assaulted but he could not fully exclude the possibility due to the severe body decomposition.

How she disappeared from the resort is still unknown.

Nora's mother said if her daughter, who had only been wearing her underwear, had somehow accidentally got outside, she would likely have sat down and waited for help.

Helen Todd, owner of the Dusun Resort, told the court her family had lived on the property for more than 30 years.

"It has always been a safe place," she said. "We have never had a burglary and we have never had an intruder in any of our houses."

She said it would "not be impossible, but it would be highly unusual" for someone to come into the resort at night.

Police maintain their investigations found nothing to suggest Nora had been kidnapped.

Alliff Benjamin Suhaimi, a lawyer representing the resort, said: "There was no evidence to suggest any foul play or any third-party intervention in respect of the case.

"So specifically, there was no reason for the police to even suspect or investigate an abduction angle to this particular issue."

The Quoirin family can still apply to the high court for a review of the verdict if they wish to, Mr Suhaimi said.

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2021-01-04 05:37:30Z
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Miami shooting: Seven shot in 'mass casualty' incident involving teen students - Daily Express

At 8:38pm local time (1:38am GMT), Miami Fire and Rescue reported seven victims had been shot at West Little River Park, 105th Street NW 24 Ave. The park neighbours the Dr Henry W. Mack/West Little River K-8 Centre School. Local talk show host Andy Slater reported law enforcement sources who stated some of the victims were teenagers. Miami-Dade Police have said “officers are already at the scene”, and have not yet delivered an update on the status of the victims.

The police department told the Miami Herald the incident is still under investigation, and the shooter is reportedly still “active”.

Alfredo Ramirez III, Miami-Dade PD director, tweeted out a plee for information form the local community.

He said: “My officers are on the scene of another tragic shooting involving juveniles.

“This type of gun violence has to end. We must work together as a community.“

On Saturday, three people were shot near Northwest Second Avenue and 18th Street.

City of Miami police are investigating the incident, with no details on the suspect at the time of writing.

Two of three victims were transported by paramedics to Ryder Trauma Centre in serious condition, claims WVSN.

Officials also told the outlet that the other victim drove themselves to Jackson Memorial Hospital.

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2021-01-04 02:41:00Z
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US election: Trump tells Georgia election official to 'find' votes to overturn Biden win - BBC News

US President Donald Trump has been recorded telling Georgia's top election official to "find" enough votes to overturn the election result.

"I just want to find 11,780 votes," Mr Trump told Republican Secretary of State Brad Raffensperger in a recording released by the Washington Post.

Mr Raffensperger is heard replying that Georgia's results were correct.

Joe Biden won Georgia alongside other swing states, winning 306 electoral college votes to Mr Trump's 232.

Since the 3 November vote, Mr Trump has been alleging widespread electoral fraud without providing any evidence.

All 50 states have certified the election result, some after recounts and legal appeals. So far, US courts have rejected 60 challenges to Mr Biden's win.

Congress is due to formally approve the election result on 6 January.

Mr Biden, a Democrat, is due to be inaugurated as president on 20 January.

Voters in Georgia are due to vote again on Tuesday to elect two senators for the state. The result could determine the balance of power in the Senate.

If the two Democrat contenders win, then there will be equal numbers of Republican and Democratic senators and Democratic Vice-president-elect Kamala Harris will have the deciding vote.

Mr Biden's Democrats already control the lower House of Representatives.

What happened during the Trump call?

In the excerpts released by Washington Post, Mr Trump can be heard alternately cajoling and pressurising Georgia's secretary of state.

He insisted that he had won the election in Georgia and told Mr Raffensperger that there was "nothing wrong with saying you have recalculated".

Mr Raffensperger responded by saying: "The challenge you have Mr President is that the data you have is wrong."

Later in the call Mr Trump said the rumour was that ballots had been shredded and voting machinery had been removed from Fulton County in the state - a charge Mr Raffensperger's lawyer said was not the case.

The president then threatened the official with possible legal consequences.

"You know what they did and you're not reporting it. That's a criminal offence. You can't let that happen. That's a big risk to you and to Ryan, your lawyer," Mr Trump said.

He then called for the extra 11,780 votes - which would have given him a total of 2,473,634 votes in the state, one more than Mr Biden, who received 2,473,633 votes.

He told Mr Raffensperger he should re-examine the result in the state.

"You can re-examine it, but re-examine it with people who want to find answers, not people who don't want to find answers," he said.

"Mr President, you have people who submit information and we have our people that submit information and then it comes before the court and the court has to make a determination," Mr Raffensperger replied. "We have to stand by our numbers, we believe our numbers are right."

On Sunday Mr Trump tweeted that Mr Raffensperger had not given details of the fraud the president alleges. "He has no clue!" the president tweeted.

Mr Raffensperger tweeted back: "Respectfully, President Trump: What you're saying is not true. The truth will come out."

Respectfully, President Trump: What you're saying is not true. The truth will come out https://t.co/ViYjTSeRcC
— GA Secretary of State Brad Raffensperger (@GaSecofState) January 3, 2021

The BBC is not responsible for the content of external sites.View original tweet on Twitter

The White House has not commented on the release of the audio.

High profile Democrat Adam Schiff said: "Trump's contempt for democracy is laid bare. Once again. On tape."

Moderate Republican Adam Kinzinger tweeted: "This is absolutely appalling. To every member of Congress considering objecting to the election results, you cannot - in light of this - do so with a clean conscience."

Analysis box by Anthony Zurcher, North America reporter

In the final weeks of his presidency, Donald Trump is struggling for ways to hold onto power. His latest act was to berate, beg and threaten Georgia's secretary of state to "find" the votes necessary to move the state to his column.

Never mind that there has been no credible evidence of substantive fraud. Never mind that Georgia has counted, then recounted, then recounted again the ballots and found no major disparities. Never mind that the Republican-controlled state has certified its election results and, even if Georgia flipped, it wouldn't be enough to re-elect Trump.

The tenor of Trump's call suggests he's not just manoeuvring for post-presidential power or trying to boost his fund-raising haul, however. He appears to firmly believe he won and is willing to use all the tools, some of questionable legality, to push state officials to shift the election in his favour.

The call is reminiscent of Trump's "I would like you to do us a favor, though" conversation with Ukrainian President Volodymyr Zelinsky, where he pressured and cajoled a foreign leader for political help.

That contact resulted in Trump's impeachment. The brazenness of Trump's Saturday call may make it more difficult for the president to rally political support to his cause.

The president's desperate times have led to the most desperate of measures.

When will the election result be certified?

There is a developing split in the Republican party after 12 senators said they would not vote to certify Mr Biden's election victory in a Senate session on 6 January.

Ted Cruz led a group of 11 senators calling for a 10-day delay to audit unsubstantiated allegations of election fraud.

Vice-President Mike Pence - who as president of the Senate is due to oversee the session and declare Mr Biden the winner - said he welcomed the move.

He stopped short of repeating allegations of fraud - but his chief of staff said Mr Pence shared what he called "the concerns of millions of Americans about voter fraud and irregularities".

Missouri Senator Josh Hawley has also said he will reject the result over concerns about the integrity of the election.

Meanwhile four senators including Mitt Romney have signed a statement saying they will vote to certify Mr Biden's win.

Top Republicans have said the Senate's role in certifying the election is largely ceremonial and should not be an opportunity for further lengthy debate about the result.

Senate Majority Leader Mitch McConnell has already recognised Mr Biden's victory and has asked other Republicans not to object.

A group of Republicans in the lower chamber of Congress, the House of Representatives, is also planning to contest the election results.

On Sunday a new Congress convened for the first time, with senators and representatives being sworn in. Democrat Nancy Pelosi was narrowly re-elected as House Speaker.

How Pelosi rose to the top - and stayed there

The House voted 216-209 for Ms Pelosi. Democrats lost 11 seats in the November elections so their majority is 222-212. Five Democrats chose not to support Ms Pelosi - two voted for lawmakers who were not running and three more voted "present".

What will happen on 6 January?

Objections that are endorsed by a member of the House of Representatives and a member of the Senate must be considered by lawmakers in a two-hour debate, followed by a vote.

However, for an objection to be upheld, a majority in both chambers must vote in favour. Republicans hold the majority in the Senate but some of their number have already said they will not contest the results.

Democrats are in the majority in the House.

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2021-01-03 22:53:00Z
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