US agency: AstraZeneca results may have ‘outdated’ data – latest updates

Tuesday, March 23, 2021

US: AstraZeneca results may have included outdated info

Results from a US trial of AstraZeneca’s vaccine may have included “outdated information” and that could mean the company provided an incomplete view of efficacy data, American federal health officials said.

AstraZeneca said in a statement that the data it released Monday included cases up to February 17, as the study rules specified, and that it was continuing to analyse cases that have occurred since then. 

The company said that a preliminary analysis of data that has continued to roll in was consistent with what it had already reported. 

It promised an update within 48 hours.

But just hours after those encouraging results were reported, the US National Institute of Allergy and Infectious Diseases issued an unusual statement.

The agency said the Data and Safety Monitoring Board “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”

Macau says suspending Pfizer vaccine over 'flawed' packaging

Health authorities in Macau have said they were suspending the use of Pfizer/BioNTech's coronavirus vaccine after being informed of a packaging problem with a batch of vials.

"Vaccinations with the concerned products must be suspended," Macau's government said in a statement. Hong Kong also suspended administration of the same vaccine, multiple local media outlets reported.

Hong Kong suspends Pfizer vaccines over packaging defects

Hong Kong has suspended vaccinations using Pfizer shots — known as BioNTech shots in the city — after they were informed by its distributor Fosun that one batch had defective bottle lids.

The suspension was immediate while Chinese pharmaceutical firm Fosun Pharma and BioNTech, the German company which created the vaccine with American pharmaceutical firm Pfizer, investigate the matter, according to a statement by the Hong Kong government.

BioNTech and Fosun Pharma have not found any reason to believe the product is unsafe, according to the statement. 

However, vaccinations will be halted as a preventive and safety measure.

Canada recommends AstraZeneca despite US criticism 

Canada has said the AstraZeneca vaccine is safe and will continue to be recommended for use despite criticism from US health officials of the drugmaker's analysis of the shot's efficacy, health officials said.

"The message is that the efficacy and the safety of the vaccine have been shown," senior Health Canada official Marc Berthiaume told reporters. "It continues to be beneficial for Canadians to prevent Covid-19."

Turkey records highest daily cases this year

Turkey has registered 26,182 new cases, the highest daily number since mid-December, health ministry data showed.

The country's overall case tally is now over 3.06 million, while the nationwide death toll has reached 30,316 with 138 more fatalities on Tuesday.

Italy reports over 18,700 new cases

Italy has reported 551 deaths, compared to 386 the day before, the health ministry said, while the daily tally of new infections rose to 18,765 from 13,846.

Italy registered 105,879 deaths since its outbreak emerged in February last year, the ministry reported, the second-highest toll in Europe after Britain and the seventh-highest in the world.

UK reports over 5,300 new cases 

The number of new confirmed cases was 5,379 in the United Kingdom, bringing the national total to 4,307,304, official data showed.

The daily number of deaths was 112, bringing the total fatalities to 126,284.

PAHO: Virus surging dangerously in Brazil

The virus continues to surge "dangerously" across Brazil, the World Health Organization's regional director for the Americas Carissa Etienne has warned, urging all Brazilians to adopt preventive measures to stop the critical spread.

The Brazilian state of Sao Paulo, the country's most populous, registered 1,021 deaths on Monday, a new daily record, state authorities said on Tuesday.

Pfizer begins early-stage study of oral virus drug

Pfizer Inc has started an early-stage US trial of an oral antiviral therapy that could be prescribed to patients at the first sign of infection, the company said.

The drugmaker said the antiviral candidate showed potent activity against SARS-CoV-2, in lab studies.

Dutch to shorten curfew despite rising cases 

A nationwide curfew to fight the Dutch outbreak will be shortened by an hour from next week, despite a rapid rise in new infections, local media has reported citing government sources.

The start of the curfew will be put back to 2100 GMT from March 31, national broadcasters NOS and RTL said, after local authorities had said daylight savings time would make it difficult for the police to enforce the original rule.

Yemen declares virus emergency as second wave accelerates

Yemen's internationally recognised government has declared a health emergency in areas under its control, as infections in a second wave of a coronavirus epidemic surge.

Yemen's six-year war has restricted testing and reporting of the virus, but numbers of confirmed cases have risen rapidly since mid-February after levelling off from September to just a couple a day.

Sweden reports over 14,000 new cases

Sweden, which has shunned lockdowns throughout the pandemic, has registered 14,063 new cases since Friday, health agency statistics showed.

The figure compared with 12,762 cases during the corresponding period last week.

The country of 10 million inhabitants registered 53 new deaths, taking the total to 13,315. The deaths registered have occurred over several days and sometimes weeks.

Vietnam approves Russia's Sputnik V vaccine

Vietnam has approved Russia's Sputnik V vaccine, its health ministry said, two weeks after the Southeast Asian country kicked off its inoculation campaign.

The shot is the second to be given the green light after the AstraZeneca vaccine.

Indonesia's rollout of AstraZeneca vaccine underway

The rollout of AstraZeneca's vaccine has started in Indonesia, the world's largest Muslim majority nation, despite concern and some confusion over whether the Anglo-Swedish product is halal, or permissible under Islam.

The country has started distributing the vaccine in six provinces, a week after the Indonesia Ulema Council, the main Muslim group that issues halal certifications, last week said it contained trypsin sourced from the pancreas of a pig.

AstraZeneca has said the vaccine contains no pork-derived ingredients.

Ukraine obliges visitors to have a negative test

All people arriving in Ukraine from March 23 will have to show a negative test for the virus, health minister Maksym Stepanov said.

Ukraine has been hit by a sharp increase in virus cases in recent weeks and said it had registered a record daily high of 333 coronavirus-related deaths over the past 24 hours.

Vietnam approves Russia's Sputnik V vaccine for use

Vietnam has approved Russia's Sputnik V vaccine for use against the virus, Russia's RDIF sovereign wealth fund, which promotes the shot globally, said in a statement on the Sputnik V website.

The Russian vaccine has now been approved in 56 countries, it said.

Vietnam's health ministry said last month that a medical panel had recommended Sputnik V and Moderna's vaccine for use.

UK health minister says mistakes were made, one year on from first lockdown

Mistakes were made in the original response to the pandemic, health minister Matt Hancock has said one year on from the first lockdown in England, adding there would be a time for an inquiry into the government's response.

"We've actively admitted that things weren't right. One of the examples I think of is how at first we thought that this virus didn't pass on if you didn't have symptoms. There were policy consequences from that assumption, and we've changed that," Hancock told BBC radio, adding that the government had already been learning from things that hadn't gone well.

Hungary cannot reopen economy before registered 65+ people are inoculated – PM

Hungary's economy cannot be reopened before all citizens older than 65 who have registered for a vaccine are inoculated, Prime Minister Viktor Orban has said.

COVAX to set aside 5 percent of vaccine doses for emergency stockpile

The COVAX vaccine-sharing scheme will set aside 5 percent of the vaccine doses it procures for a "buffer" to be used in humanitarian settings or released in the case of severe outbreaks, the GAVI vaccine alliance said.

That amounts to up to 100 million vaccine doses by the end of 2021, it said.

Czech Republic's death toll surpasses 25,000, doubling in 2021

The Czech Republic has said that the total number of deaths related to the virus had passed the 25,000 mark, more than doubling since the start of 2021.

The country of 10.7 million has been one of the countries hardest-hit by the pandemic and has the world's second-highest per capita death toll according to the Our World in Data website.

The overall figure had risen to 25,055 by the end of Monday, health ministry data showed. In March, the country has seen on average almost 194 deaths a day from the virus.

France to open 35 vaccine supersites 'in coming days'

France will open 35 mass vaccination centres "in the coming days" to ramp up the pace of inoculations, a government minister said, amid criticism the campaign is too slow.

"We are working with local representatives to put them in place," Industry Minister Agnes Pannier-Runacher told BFMTV channel.

France had previously baulked at setting up supersites to rapidly dispense vaccines in large numbers after a failed experiment with "vaccinodromes" during the H1N1 swine flu pandemic in 2009.

Germany backs EU vaccine nationalism in blocking exports

German Chancellor Angela Merkel has voiced support for EU chief Ursula von der Leyen's threat to block AstraZeneca vaccines produced in the bloc from being exported, ahead of a crunch EU summit on the escalating row.

"I support Commission President Ursula von der Leyen," said Merkel.

"We have a problem with AstraZeneca," she added.

European officials are furious that AstraZeneca has been able to deliver its UK contract in full while falling short on its supplies to the EU.

AstraZeneca may have included 'outdated' data in US vaccine – regulator

AstraZeneca may have included out-of-date drug data in information provided during US trials for its vaccine, a regulator said late Monday, citing concerns from a monitoring board.

The board "expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data," a statement from the National Institute of Allergy and Infectious Diseases said.

Germany orders tough Easter shutdown as EU AstraZeneca row simmers

Germany has said it will impose a strict lockdown for five days over Easter as infections spiral "exponentially", while a row over exports of the AstraZeneca vaccine festers in Europe.

Chancellor Angela Merkel ordered the harsh nationwide measures after marathon talks with regional leaders, warning a potent strain of virus was raging through the EU's most populous country.

"The situation is serious," Merkel said. "Case numbers are rising exponentially and intensive care beds are filling up again."

Chile extends rescue package to June as second wave bites

Chile will extend a virus rescue package to help poor and middle-class families and small businesses stay afloat until June as the Latin American nation struggles to slow the second wave of cases despite a rapid vaccine rollout.

President Sebastian Pinera said the latest announcements represented a 50 percent increase to the $12 billion package announced last June, when Chile was engulfed in a first wave of cases, to $18 billion, representing 2 percent of Chile's gross domestic product.

First vaccines arrive in virus-hit Papua New Guinea

Papua New Guinea has received its first batch of vaccines as the country raced to quell a virus surge overwhelming its fragile health system.

An initial shipment of 8,000 doses of the AstraZeneca vaccine was flown in from neighbouring Australia, earmarked to protect badly hit frontline hospital staff.

Prime Minister James Marape greeted the grey air force C-17 bearing the vaccine, three mobile storage facilities and a small team of Australian public health specialists at Jacksons International Airport in Port Moresby.

Ukraine reports record daily high of 333 deaths

Ukraine has registered a record daily high of 333 virus-related deaths over the past 24 hours, the health minister, Maksym Stepanov, said.

The previous high of 289 deaths was on March 17.

Stepanov said 11,476 new infections were reported over the past 24 hours. Ukraine has reported a total of 1,565,732 virus cases and 30,431 deaths.

US health agency questions robustness of AstraZeneca's vaccine trial data

AstraZeneca Plc may have provided an incomplete view of efficacy data on its vaccine from a large scale US trial, a US health agency said in a fresh setback for the shot.

The news comes just one day after interim data from the drugmaker showed better-than-expected results from the trial and casts doubt on its plan to seek US emergency use authorisation for the vaccine in the coming weeks.

The vaccine developed with Oxford University was 79 percent effective in preventing symptomatic illness in a large trial in the United States, Chile and Peru, and, crucially, posed no increased risk of blood clots, according to the data

Germany reports 7,485 cases – RKI

The number of confirmed virus cases in Germany has increased by 7,485 to 2,674,710, data from the Robert Koch Institute (RKI) for infectious diseases showed. 

The death toll rose by 250 to 74,964, the tally showed.

'Children have stronger antibody response'

Children who are 10 and younger produce more antibodies in response to coronavirus infection than adolescents and adults, a study has shown.

The authors of the paper, which appeared in JAMA Network Open, said the finding helped illuminate why children are less susceptible to severe Covid-19 than adults - though this is still an area of very active research and many factors are believed to be at play.

The fact that children are less prone to severe Covid-19 is in some ways counterintuitive, given how much they are affected by other respiratory illnesses, and many theories abound.

A paper in Nature Communications last month by researchers in Australia suggested children have a more active "innate" immunity – the immune system's first line of defense which gets triggered before it raises antibodies, and involves cells such as neutrophils that patrol the body looking for infections.

Another theory is linked to the fact that children have fewer cell receptors in their respiratory tracts called "ACE2" which the coronavirus uses to gain entry to our cells.

One paradoxical result from the new research was that antibody levels were lowest for young adults but rose again with age – despite the fact that we know older people are more vulnerable.

UN chief concerned by rise in anti-Asian violence

United Nations Secretary-General Antonio Guterres is concerned about the rise of violence against Asians and people of Asian descent globally during the Covid-19 pandemic, a UN spokesman said.

While the UN statement does not single out any countries, it comes after a shooting in Atlanta earlier this month left eight people dead, six of them Asian-American women.

The shooting stoked fears among those in the Asian-American Pacific Islander community, which has reported a spike in hate crimes since March 2020 when then-President Donald Trump began referring to Covid-19 as the "China virus."

"The world has witnessed horrific deadly attacks, verbal and physical harassment, bullying in schools, workplace discrimination, incitement to hatred in the media and on social media platforms, and incendiary language by those in positions of power," UN spokesman Farhan Haq said.

"In some countries, Asian women have been specifically targeted for attack, adding misogyny to the toxic mix of hatred," he said.

UK's Johnson marks lockdown anniversary

Prime Minister Boris Johnson has praised the "great spirit" shown by Britain in tackling Covid-19, marking a year since the first lockdown by saying everyone's efforts had allowed the country to start "on the cautious road" to easing restrictions.

With Britain suffering one of the highest death tolls from the coronavirus, Johnson has come under fire for moving too slowly last year to tackle the first and second waves of the pandemic, with some accusing him of prioritising the economy over health.

But since then, his government has overseen a successful vaccine rollout, reaching more than half of the adult population, and a cautious approach to easing the latest lockdown, prompting a recovery for him in opinion polls.

"Today, the anniversary of the first lockdown, is an opportunity to reflect on the past year – one of the most difficult in our country's history," Johnson said in a statement.

Miami Beach extends spring break curfew

The US city of Miami Beach, overrun by crowds of spring break tourists throwing Covid caution to the wind, has extended a state of emergency to stem the chaos - drawing accusations of unfairly tough tactics against mostly Black revelers.

Video and photos on social media show half-naked women twerking on the roofs of cars, men offering them wads of bills and a crowd of tourists huddled side by side, dancing and passing bottles from hand to hand - plus brawls, gunshots fired in the air and stand-offs with police.

"A lot of times when spring breakers come, whether they're black, white or whatever, there is some sort of anarchy," Retha Boone-Fye, program director for the Black Affairs Advisory Board of Miami-Dade County, told AFP, saying the city had every right to expect visitors to behave.

"Where we part ways is the way that the black visitors are dealt with," she said.

South Korea's Moon receives AstraZeneca's vaccine

South Korea's President Moon Jae-in has received AstraZeneca's coronavirus vaccine as he prepared to visit the United Kingdom for a G7 summit in June, his office said.

Moon, 68, attended a community clinic near his office in downtown Seoul with his wife and nine senior officials who will accompany him on the trip, including National Security Advisor Suh Hoon, the presidential Blue House said in a statement.

Brazil records 49,293 new cases, 1,383 deaths

Brazil recorded 49,293 new cases of coronavirus and 1,383 new Covid-19 deaths, the Health Ministry said.

China reports nine more infections

China has reported nine new Covid-19 cases on March 22, up from seven cases a day earlier, the country's national health authority said on Tuesday.

The National Health Commission said in a statement all the new cases were imported infections. The number of new asymptomatic cases, which China does not classify as confirmed cases, rose to 14 from eight cases a day earlier.

Total confirmed Covid-19 cases in Mainland China now stand at 90,106. The death toll remains unchanged at 4,636.