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10 dead, 38 injured in China bus, truck collision

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Beijing, March 3, 2017: Ten people died and 38 others were injured when a cement tanker crashed into a bus Thursday night in southwest China’s Yunnan Province, the local government said.

The accident happened at 11:33 p.m. on a highway in Yunxian County of Lancang City, the city government’s press office said in a statement Friday.

The cement tanker, with a license plate from the neighboring Sichuan Province, veered off the road after colliding into a coach bus that was carrying 47 people, including two drivers, Xinhua news agency reported.

The bus, en route from Gengma County to the provincial capital Kunming, overturned on the road, the document said.

It said nine people were confirmed dead at the scene and another one died later in hospital, but did not identify the victims.

The government had launched an investigation and the injured people had been landed in hospitals, the document said.

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UK Approves Pfizer-BioNTech Covid Vaccine For Use, First In The World

The country has ordered up to 40 million doses of the vaccine that is said to offer 95 per cent protection.

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Pfizer and BioNTech say they’ve won permission Wednesday for emergency use of their Covid-19 vaccine in Britain, the world’s first coronavirus shot that’s backed by rigorous science — and a major step toward eventually ending the pandemic.

The move makes Britain one of the first countries to begin vaccinating its population as it tries to curb Europe’s deadliest Covid-19 outbreak.

Other countries aren’t far behind: The U.S. and the European Union also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna Inc.

Pfizer said it would immediately begin shipping limited supplies to the U.K. — and has been gearing up for even wider distribution if given a similar nod by the U.S. Food and Drug Administration, a decision expected as early as next week.

But doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.

Pfizer CEO Albert Bourla called the U.K. decision “a historic moment.”

“We are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” Bourla said in a statement.

While the U.K. has ordered enough Pfizer vaccine for 20 million people, it’s not clear how many will arrive by year’s end and adding to the distribution challenges is that it must be stored at ultra-cold temperatures.

Two doses three weeks apart are required for protection. First in line, the U.K. government says, are frontline health care workers and nursing home residents, followed by older adults.

British regulators also are considering another shot made by AstraZeneca and Oxford University. But Prime Minister Boris Johnson has warned “we must first navigate a hard winter” of restrictions to try to curb the virus until there’s enough vaccine to go around.

Every country has different rules for determining when an experimental vaccine is safe and effective enough to use. Intense political pressure to be the first to roll out a rigorously scientifically tested shot coloured the race in the U.S. and Britain, even as researchers pledged to cut no corners. In contrast, China and Russia have offered different vaccinations to their citizens ahead of late-stage testing.

The shots made by U.S.-based Pfizer and its German partner BioNTech were tested in tens of thousands of people. And while that study isn’t complete, early results suggest the vaccine is 95% effective at preventing mild to severe Covid-19 disease. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot.

“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO, recently told The Associated Press.

The companies also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.

But experts caution that a vaccine cleared for emergency use is still experimental and the final testing must be completed. Still to be determined is whether the Pfizer-BioNTech shots protect against people spreading the coronavirus without showing symptoms. Another question is how long protection lasts.

The vaccine also has been tested in only a small number of children, none younger than 12, and there’s no information on its effects in pregnant women.

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UK vaccine approval ‘historic moment’ in Covid-19 battle: Pfizer CEO

The Pfizer-BioNTech COVID-19 vaccine will be made available across the UK from next week.

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The United Kingdom has become the first country to authorise the Pfizer-BioNTech COVID-19 vaccine for use. Britain on December 2 said that the COVID-19 vaccine will be rolled out for use from next week.

“The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s COVID-19 vaccine for use,” the government said.

“The vaccine will be made available across the UK from next week,” it added.

Pfizer said Britain’s emergency use authorization marks a historic moment in the fight against COVID-19. “This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said Pfizer CEO Albert Bourla.

“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” Bourla added.

Health Secretary Matt Hancock said the programme would begin early next week. “Hospitals are already ready to receive the COVID-19 vaccine. It is very good news,” Hancock said.

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Moderna Says Vaccine 100% Effective Against Severe Covid, Seeks Clearance

COVID-19 Vaccine: Moderna said it expects to have approximately 20 million doses of the vaccine, called mRNA-1273, available in the US by the end of the year.

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Washington: Moderna Inc will apply for US and European emergency authorization for its COVID-19 vaccine on Monday after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said. Moderna also reported that the vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people.

The filing sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorization this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate in trials. “We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna Chief Medical Officer Tal Zaks said.

“We expect to be playing a major part in turning around this pandemic.”

Of the 196 volunteers who contracted COVID-19 in the trial with more than 30,000 people, 185 received a placebo while 11 got the vaccine.

Moderna reported 30 severe cases — all in the placebo group — which means the vaccine was 100% effective in preventing severe cases.

“As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public,” said Alexander Edwards, associate professor in biomedical technology at Britain’s University of Reading.

In addition to filing its US application, Moderna said it would seek conditional approval from the European Medicines Agency, which has already begun a rolling review of its data, and would continue to talk with other regulators.

Pfizer has already applied for emergency use authorization in the United States and Europe, putting it about a week ahead of Moderna.

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.

Both of the vaccines use a new technology called synthetic messenger RNA (mRNA) whereas others, such as Britain’s AstraZeneca, are using more traditional methods to develop their vaccines.

AstraZeneca has announced an average efficacy rate of 70% for its shot and as much as 90% for a subgroup of trial participants who got a half dose, followed by a full dose.

But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.

Moderna’s latest efficacy result is slightly lower than an interim analysis released on Nov 16 of 94.5% effectiveness, a difference that Mr Zaks said was not statistically significant.

“At this level of effectiveness, when you just do the math of what it means for the pandemic that’s raging around us, it’s just overwhelming,” said Zaks, who said he cried when he saw the final results over the weekend.

Both the Moderna and Pfizer vaccines proved more effective than anticipated and were far superior to the 50% benchmark set by the US Food and Drug Administration (FDA).

The past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and comes as new infections and COVID-19 hospitalizations are at record levels across the United States.

Independent advisers to the FDA are scheduled to meet on December 17 to review Moderna’s trial data and make a recommendation to the FDA.

They will meet on December 10 to review Pfizer’s data. Shortly after gaining emergency use authorization, Moderna expects the vaccine to be shipped to distribution points throughout the United States by the government’s Operation Warp Speed program and McKesson Corp, a drug distributor contracted by the US government.

Its distribution is expected to be easier than Pfizer’s because while it needs to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer’s vaccine.

Moderna said the 196 COVID-19 cases in its trial included 33 adults over 65 years old and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants. There was one death related to COVID-19 in the placebo group.

Azra Ghani, chair in infectious disease epidemiology at Imperial College London, said Monday’s details from Moderna confirmed the vaccine was highly efficient, including against severe cases. “Whilst this does not exclude some risk of severe disease after vaccination given the relatively small number of severe cases, these results suggest very high efficacy,” she said.

Zaks said the vaccine has been developed during a period of “political acrimony” and having a highly effective vaccine may go a long way toward erasing some of that distrust. “This is as black and white as an effect on a population will be. Your chances of actually being sick if you’ve been vaccinated are decreased 20-fold,” he said.

Moderna reported no new side effects since its interim analysis. Based on that analysis, the most common side effects were fatigue, injection site redness and pain, headache and body aches, which rose after the second dose and were short-lived.

Zaks said the vaccine caused significant flu-like symptoms in some participants, which, he said, “goes hand-in-hand with having such a potent vaccine.” But it has not caused any significant safety concerns so far.

Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another in even younger volunteers early in 2021.

It hopes to have the vaccine available for adolescents by September, Zaks said.

Other vaccine makers have said they are studying their vaccines in young people as well.

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