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Thursday 31 December 2020

China gives its first Covid-19 vaccine approval to Sinopharm

 BEIJING (Reuters) - China approved its first COVID-19 vaccine for general public use on Thursday, a shot developed by an affiliate of state-backed pharmaceutical giant Sinopharm, as it braces for greater transmission risks over the winter.

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No detailed efficacy data of the vaccine has been publicly released but its developer, Beijing Biological Products Institute, a unit of Sinopharm subsidiary China National Biotec Group (CNBG), said on Wednesday its vaccine was 79.34% effective in preventing people from developing the disease based on interim data.

The approval, announced by the National Medical Products Administration, comes after the United Arab Emirates this month became the first country to roll out the vaccine to the public, and as Pakistan announced a 1.2 million dose purchase deal with Sinopharm.

While China has been slower than several other countries in approving COVID-19 vaccines, it has been inoculating some citizens for months with three different shots still undergoing late-stage trials.

China launched an emergency use programme in July aimed at essential workers and others at high risk of infection, had administered more than 4.5 million doses as of Dec. 15 using at least three different products - two developed by CNBG and one by Sinovac Biotech.

While the efficacy of the Sinopharm shot trails the more than 90% success rate of rival vaccines from Pfizer Inc and its partner BioNTech SE and Moderna Inc, it points to progress China has made in the global race to develop successful COVID-19 vaccines.

China has at least five vaccines, developed by Sinovac, CNBG units, CanSino Biologics and the Chinese Academy of Sciences, in late stage trials, underscoring its efforts to develop a homegrown vaccine to challenge Western rivals.

RELATED COVERAGE

President Xi Jinping has pledged to make China’s vaccines a global public good and it has won several large supply deals with countries including Indonesia and Brazil - the most populous countries in Southeast Asia and Latin America respectively.

WATCHING THE DATA

The efficacy and safety data of China-made vaccines is being closely watched by many developing countries as they have limited early access to shots developed by Western drug makers and are looking for alternatives from China and Russia.

“China’s approval could boost the credibility of the vaccine,” said Dong-yan Jin, a professor at the University of Hong Kong.

“But if the vaccine wants to take a share in the global market, especially in developed countries, more data is necessary.”

A Sinopharm executive told a briefing detailed data would be released later and published in scientific journals at home and abroad.

While China has kept new outbreaks of the coronavirus under control, it is ramping up the emergency programme to contain the risks over the winter. The virus emerged a year ago in a market in the central city of Wuhan.

The South China Morning Post newspaper reported that China would vaccinate as many as 50 million people from high-priority groups before the Lunar New Year holiday in February.

“We call on people ... to take an active part in vaccination to protect themselves, family members and others, which is also contributing to global epidemic control,” Zeng Yixin, an official with National Health Commission, told a briefing on Thursday.

The price of the vaccine would depend on the scale of use, but the “premise” was that it would be free for the public in China, he said.

The approval comes as Britain on Wednesday approved a second COVID-19 vaccine, a shot developed by Oxford University and AstraZeneca, as it battles a major winter surge driven by a new variant of the virus.

https://www.reuters.com/article/us-health-coronavirus-vaccine-china-idUSKBN29505P

The EU’s AstraZeneca vaccine dispute and U-turn explained

 The European Union has retreated from a plan to override part of the Brexit deal on Northern Ireland over export controls on coronavirus vaccines.

 31 January 2021

© Peter Byrne NHS staff prepare to administer a Oxford/AstraZeneca Covid-19 vaccine (Peter Byrne/PA)

But following widespread condemnation of the move, the EU is facing further criticism over its decision to push ahead with imposing controls on vaccines manufactured within member states.

It comes amid a bitter row between the bloc and AstraZeneca over shortfalls in delivery of the pharmaceutical company’s Covid-19 vaccine, which was authorised for use in adults throughout the EU on Friday.

Here, the PA news agency looks at the U-turn and how the row has unfolded.

– What prompted the political uproar?

On Friday, Brussels announced it would invoke Article 16 of the Northern Ireland Protocol to stop the country being used as a back door to move coronavirus vaccines from the bloc into the UK.

The EU later reversed the move following condemnation from London, Dublin and Belfast.

–  Why did the EU announce the plan?

The NI Protocol, which is part of the Withdrawal Agreement, is designed to allow the free movement of goods from the EU into Northern Ireland, preventing the need for a hard border on the island of Ireland.

But triggering Article 16 would have temporarily placed export controls on the movement of vaccines as the EU moves to protect its own supplies.

– And why did it make a U-turn?

The protocol move provoked condemnation from both sides of the Irish border – with Northern Ireland’s First Minister Arlene Foster calling it an “incredible act of hostility”.

Boris Johnson expressed “grave concerns” to European Commission president Ursula von der Leyen and also discussed the issue with Irish premier Micheal Martin, who reportedly was not given advance notice of Brussels’ decision.

The European Commission then reversed the decision and announced it was “not triggering the safeguard clause” to ensure the protocol is “unaffected”.

– Why does the EU have issues with its vaccine supplies?

AstraZeneca has said initial deliveries to the EU will fall short because of a production glitch – said to be at a hub in Belgium – and it will not be able to meet its supply targets for the first three months of this year.

The British-Swedish company announced initial deliveries in the EU would total approximately 31 million doses – rather than the anticipated 80 million in the first quarter.

With the speed of the UK’s vaccine rollout outstripping other European countries, the EU has suggested doses produced in Britain should be directed elsewhere to make up the shortfall.

Ms von der Leyen has called for an explanation from AstraZeneca for delivery hold-ups, as she insisted the supply orders are “binding” and “the contract is crystal clear”.

– Has AstraZeneca responded?

In an interview with Italy’s la Repubblica newspaper, AstraZeneca chief executive Pascal Soriot had said the contract only committed to meet the EU’s demands to its “best effort”.

He said the EU’s deliveries were delayed in part because the bloc signed its contract later than the UK, and therefore EU manufacturing facilities were still catching up.

AstraZeneca and its partner Oxford University signed a deal with the UK Government for 100 million doses three months before the EU deal for 400 million doses was agreed, according to Mr Soriot.

– What else has the EU said?

On Friday, the European Commission tightened the rules on the export of vaccine doses produced in the 27 EU countries.

The “vaccine export transparency mechanism″ will be used until the end of March to control vaccine shipments to non-EU countries, with any exporting company required to submit its plans to national authorities.

Officials have insisted the measure is not an export ban and that the move is intended to ensure member nations receive doses they bought from vaccine producers.

– Could the UK’s vaccine supply be affected?

These controls could hinder the UK’s access to further supplies, particularly to the Belgian-made Pfizer jab, which the UK is scheduled to get 3.5 million doses of over the next three weeks.

Meanwhile, the majority of the UK’s AstraZeneca/Oxford vaccine supply is manufactured in the UK rather than at the firm’s Belgium plant, so it is not expected to be disrupted by the row.

– How many doses of vaccine has the UK ordered?

The UK Government has so far secured 40 million doses of the BioNTech/Pfizer vaccine and 100 million of the Oxford/AstraZeneca jab.

© Provided by PA Media (PA Graphics)

It has also ordered 17 million from Moderna, the most recently approved vaccine, although supplies are not expected to arrive until spring.

The UK has also secured 60 million doses of the Novavax jab with the hope that the Medicines and Healthcare products Regulatory Agency will approve it for use within weeks.

– How is the rollout progressing in the UK?

Government data shows more than 7.8 million people in the UK have received a first dose of either the Pfizer or AstraZeneca vaccine.

https://www.msn.com/en-gb/news/uknews/the-eus-astrazeneca-vaccine-dispute-and-u-turn-explained/ar-BB1deoay?li=AAnZ9Ug

Wednesday 30 December 2020

Wuhan’s Covid Cases May Have Been 10 Times Higher, Study Shows

 The number of coronavirus cases in the Chinese city where the pathogen was first detected may have been 10 times higher than official figures suggest, according to a study by health authorities in Wuhan.

Issued on: 

About 4.4 percent of the city's 11 million residents had developed antibodies against the virus causing Covid-19 by April, the report by the Chinese Centre for Disease Control (CDC) said.

That correlates to around 480,000 infections in Wuhan by April, nearly 10 times the official tally to date of 50,000 cases in the city.

China has faced a barrage of criticism at home and abroad over its initial handling of the virus, including attempts to silence whistle-blowers and not reporting any cases for days in early January amid high-level political consultations. 

On Monday, citizen journalist Zhang Zhan was jailed for four years for reporting on conditions inside Wuhan during the height of the outbreak.

The discrepancy revealed by the CDC's data may "point to potential underreporting due to the chaos in late January and early February, when a large number of people were not tested or were not tested accurately for Covid-19," Huang Yanzhong, a senior fellow for global health at the Council on Foreign Relations (CFR), told AFP.

Qin Ying, a serological expert from the CDC told AFP on Wednesday that disparities in data were not unique to China.

"Several countries have already published similar serological surveys and... in most instances the number of people with antibodies against the coronavirus was several times higher than the confirmed case count," Qin said. 

"So this kind of disparity is a widespread phenomenon."

The CDC added that only 0.44 percent of the population in central Hubei province outside of Wuhan exhibited antibodies for the virus, suggesting that the 77-day lockdown on the city may have helped prevent the spread of the disease.

The findings of the survey of more than 34,000 people across the country conducted in April was only released late Monday.

China does not include asymptomatic cases in its official tally, which could also explain the discrepancy between the total confirmed cases and the actual number infected.

The country's total number of cases stands at 87,027 with 4,634 deaths, according to data from the National Health Commission on Wednesday. 

China has largely curbed the virus at home, and was the only major economy to report positive economic growth this year as restrictions on businesses and internal travel were lifted. 

Even in Wuhan the "rate is not as high as that in New York City (23 percent by September), which may suggest the (Chinese) government containment efforts were speedy and effective", Huang said. 

Officials have also rushed to test tens of millions of people to squash local mini-outbreaks.

https://www.france24.com/en/asia-pacific/20201230-wuhan-covid-19-cases-may-have-been-ten-times-higher-than-first-reported-study-finds

UK to roll out Astra/Oxford COVID vaccine after world-first approval

 Britain on Wednesday became the first country to approve the coronavirus vaccine developed by Oxford University and AstraZeneca, hoping that rapid action will help it stem a record surge of infections driven by a highly contagious form of the virus.

Prime Minister Boris Johnson’s government, which has ordered 100 million doses, had already fast-tracked approval of a vaccine developed by Pfizer and Germany’s BioNTech, and administered hundreds of thousands of shots weeks ahead of European Union countries and the United States.

Though cheaper and easier to distribute than rival vaccines, the AstraZeneca/Oxford shot has been plagued with questions about its most effective dosage ever since data published last month showed some surprising results.

While other regulators have taken a more cautious approach, Britain’s MHRA was at pains to say it had resolved early doubts and - unexpectedly - that it had found an 80% success rate for the administration of two full doses, three months apart, higher than the average that the developers themselves had found.

The government plans to take advantage by giving the first dose to a larger number of people most at risk from COVID-19 before starting to administer the boosters.

An advisory body recommended doing the same with the Pfizer shot, though Pfizer said its vaccine had not been tested on different dosing schedules.

Jeremy Farrar, one of Britain’s leading public health experts, said the approval of the AstraZeneca/Oxford shot was to be celebrated, but urged continuing scrutiny, recommending the developers conduct a randomised trial to test the timing of the second dose.

Jonathan Stoye, a virologist at the Francis Crick Institute, agreed that questions remain about the real efficacy of the vaccine, how well it works in older people, and what data exists to support the change in dosage interval.

“In light of the sharply increasing number of cases, the approval... is tremendous news,” he said. “However, the reported news does leave unanswered a number of important questions, particularly regarding the longer term.”

RELATED COVERAGE

The government said it would not recommend one vaccine over another for different cohorts of the population, even though data on the AstraZeneca/Oxford shot’s efficacy in older people is currently limited.

INFECTIONS SOAR

Britain has already registered over 70,000 deaths from COVID-19. On Tuesday it reported a record one-day jump of 53,135 new coronavirus infections, and it fears hospitals will soon become overstretched in their peak winter months.

The AstraZeneca/Oxford vaccine could also be a game-changer for global immunisation. Countries with relatively basic health infrastructure have high hopes for a shot that, unlike Pfizer’s, can be stored and transported under normal refrigeration, rather than supercooled to -70 degrees Celsius (-94 Fahrenheit).

India’s Serum Institute of India (SII), the world’s biggest producer of vaccines, has made about 50 million doses of the Oxford vaccine.

Experts at India’s drug regulator met on Wednesday to consider an emergency approval, and will discuss the issue again on Friday. Chile is also interested.

World Health Organization spokesman Tarik Jasarevic said the latest vaccine was important for its “delivery attributes, the potential scale and affordability”.

Helen Fletcher, Professor of Immunology at the London School of Hygiene and Tropical Medicine, hailed a “turning point” for the pandemic, which has already killed 1.7 million people around the world, sown chaos through the global economy and upended normal life for billions.

“With more than 30 supply agreements and partner networks established globally, the Oxford/AstraZeneca vaccine could slow the pandemic and should save many lives within the next year,” she said.

EU DECISION SOON?

The EU regulator says it has not yet received full data on the AstraZeneca shot and is unlikely to be able to approve it next month, although Germany’s top vaccine official said that a rolling review of data meant a quick decision should be possible.

Canada said it needs more information from the British drugmaker as part of its ongoing review.

The UK’s COVID-19 vaccine chair Wei Shen Lim said a single dose of AstraZeneca/Oxford’s vaccine was around 70% effective from 21 days until a second dose was given at 12 weeks.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) cleared up one doubt raised by the Oxford data, saying that a 90% success rate for a half-dose followed by a full dose had not stood up to analysis.

A Reuters investigation detailed how the apparently more effective dosing regime was the result of a miscalculation.

However, Munir Pirmohamed, chair of a government working group on COVID-19 vaccines and involved in the approval, said that when two full doses were given three months apart, “effectiveness was high, up to 80% ... which is the reason for our recommendation”.

AstraZeneca Chief Executive Pascal Soriot told BBC radio that Britain should be able to vaccinate tens of millions of people by the end of the first quarter. The firm said it expected the vaccine to work against the new variant.

Health Secretary Matt Hancock told Sky News that he was “highly confident that we can get enough vulnerable people vaccinated by the spring that we can now see our route out of this pandemic”.

Reporting by Alistair Smout and Paul Sandle in London; Additional reporting by Pushkala Aripaka in Bengaluru, Josephine Mason and Kate Kelland in London, John Miller in Zurich, Emilio Parodi in Milan and Rebecca Spalding; Editing by Guy Faulconbridge, Kevin Liffey and Jan Harvey

https://www.reuters.com/article/uk-health-coronavirus-britain-vaccine/uk-to-roll-out-astra-oxford-covid-vaccine-after-world-first-approval

Monday 28 December 2020

China's vaccine diplomacy not as simple as shot in the arm

 BEIJING - Early on in the coronavirus outbreak as countries were grappling with the rapid spread of the disease, China sent boxes upon boxes of masks and other protective equipment abroad.

Danson Cheong

Beijing has been given a second chance to repair its international image and position itself as part of the global solution to the pandemic.PHOTO: REUTERS


They arrived in various countries bearing stickers of the Chinese flag in a display of what has been called "mask diplomacy".

With the world in the grip of a raging pandemic, it was a golden opportunity for China to reshape the narrative of how it mishandled the initial stages of the Covid-19 outbreak, and to position it as a global leader at a time of great need.

But as it has since turned out, the public relations campaign was a flop. Reports of unscrupulous private Chinese firms selling sub-standard masks, test kits and ventilators tarnished efforts to win goodwill. Overzealous Chinese diplomats who asked recipient countries for praise and gratitude also raised questions about Beijing's altruism.

But now, as testing for China's Covid-19 vaccines nears completion, Beijing has been given a second chance to repair its international image and position itself as part of the global solution to the pandemic.

On paper, Beijing looks to be in a good position to expand its soft power and influence. With infections within its borders under control, China has greater latitude to distribute its vaccines overseas - unlike the United States, which has prioritised inoculating Americans first.

In May, Chinese President Xi Jinping said that Chinese vaccines would be a "global public good", and China subsequently joined the World Health Organisation-backed Covax initiative - from which the US is conspicuously absent - to help ensure equitable global distribution of Covid-19 vaccines.

Professor Steve Tsang of the SOAS China Institute in London said there was "no doubt that Beijing is trying to use the supply of vaccines to boost its soft power".

"But a lot will depend on how it goes about it," he said, pointing out that it was unlikely Chinese-made vaccines would be provided for free after they have completed clinical tests.

Beijing has no doubt learnt from its earlier mistakes, but this latest "vaccine diplomacy" push is not as straightforward as it seems.

Soft power push

Of the 18 vaccines currently in phase-three clinical trials, five are from China. These are being developed by four vaccine makers which are conducting trials in some 16 countries.

Chinese vaccine makers have had to go abroad to conduct final stage testing, since they require vaccines to be field-tested in an environment where the virus is still spreading. In return, these countries have been given preferential access to Chinese vaccines.

State media reported this month that some 500 million doses of Chinese vaccines have been ordered by foreign countries so far, largely by host countries where these drugs are being tested.

Developed countries have snapped up Western-made vaccines, leaving a gap in the developing world that experts say China is moving in to fill.

Rich nations have bought almost all of next year's supply of the two vaccine frontrunners by Pfizer-BioNTech and Moderna, according to the People's Vaccine Alliance (PVA), a network of organisations including Amnesty International, Oxfam and Global Justice Now.

Canada, for instance, has ordered enough vaccines to inoculate each Canadian five times, although it has pledged to share any excess with other countries.

The situation is such that nine in 10 people in 67 developing countries - including nations such as Cambodia, Laos and Pakistan - stand little chance of being vaccinated next year, said the PVA this month.

To these countries, China's vaccines are a lifesaver.

The United Arab Emirates (UAE) and Bahrain this month became the first two countries to grant full approval to a vaccine made by state-owned firm Sinopharm, even before full clinical trial results have been published.

While Beijing has rejected claims that it is using its vaccines as a tool for global influence, saying it is committed to sharing its vaccines with the world, it is not hard to see how its posturing over its vaccines align with its foreign policy goals.

Dr Huang Yanzhong, a senior fellow for global health at the Council on Foreign Relations in New York City, said Beijing's actions present this image of a "benign great power providing access to countries excluded from the global distribution of these vaccines".

But they also expand the market share for Chinese vaccines in the developing world, since the Western alternatives have largely cornered the developed market.

"When you look at those countries they want to prioritise vaccine access for, all of them are in the developing world, almost all of them are covered by the (Belt and Road Initiative), and some of those countries are considered strategically important to Beijing, like Pakistan and Indonesia," said Dr Huang.

Top Chinese leaders have promised priority access to countries including Cambodia, Myanmar, Laos, Thailand, Vietnam, Malaysia, and African nations.

Indonesia received 1.2 million doses of Sinovac's vaccines this month. Another 1.8 million doses are expected to arrive in January.

Lack of transparency

The dearth of data around China's vaccine candidates is unsettling.

Both Pfizer and Moderna have announced that their vaccines appear to be about 95 per cent effective, while the vaccine produced by Oxford University and AstraZeneca has an efficacy of up to 90 per cent.

But none of the Chinese vaccine candidates have released official preliminary data from phase three trials.

The UAE, which approved the Sinopharm vaccine, said trials in the country showed the drug to be 86 per cent effective. Meanwhile, Brazil said a clinical trial on Sinovac Biotech's vaccine in the country yielded more than 50 per cent effectiveness - the minimum standard set by US regulators for emergency authorisation of Covid-19 vaccines.

Chinese health authorities have pointed to the fact that more than a million Chinese have been inoculated with the experimental vaccines under emergency-use protocols without any adverse reactions, as proof of its safety.

Without transparent data on their vaccines, however, Beijing will find it hard to inspire confidence in what it has to offer.

Last week, Hong Kong said its residents will be allowed to choose which shot they want to take among several vaccine candidates that will likely include Sinovac's.

It also does not help that past vaccine scandals in China have sapped global confidence, including one as recent as 2018 where a leading vaccine manufacturer was found to have made rabies vaccines with expired products.

"Chinese-made vaccines don't have a good established reputation in the developed world, and given its domestic record, this is an important factor as to why countries are still sceptical about China's vaccines," said Dr Huang.

Put simply, for China's soft power push to work, its vaccines must be shown to be effective and stand up to scientific scrutiny.

Unlike masks and test kits, vaccines are injected into the human body and cannot be jettisoned if found to be faulty.

No free lunch

At the same time, there are worries that China's vaccine push could hand it too much leverage in the region, said Mr Lye Liang Fook, senior fellow at the ISEAS-Yusof Ishak Institute in Singapore. Being dependent on Chinese vaccines could cause countries to tone down their criticism of China when it comes to territorial disputes.

Mr Lye pointed out that Asean nations like Malaysia, the Philippines and Indonesia have been conscious about not relying solely on China-made vaccines. These countries are also signing deals with other firms such as Pfizer, AstraZeneca and Russia's Gamaleya Institute.

Malaysia and the Philippines have competing claims with China in the South China Sea while Indonesia and China are in dispute over fishing rights around Indonesia's Natuna islands.

Notably, Cambodian Prime Minister Hun Sen said recently that the country would only accept vaccines approved by the WHO, and that his country was not a "dustbin" for Chinese trial vaccines.

"It tells you that even countries that are more amenable to China are, at least publicly, showing that they are being politically conscious," said Mr Lye.

The worry is that Beijing could use the supply of vaccines as leverage to achieve its geopolitical goals in the region, or cut off the supply should there be disagreements.

Political tensions between China and Canada are believed to be the reason the Chinese authorities blocked Tianjin-based company CanSino Biologics from shipping its test vaccines to Canada for trials a few months ago.

Immunity gap

Some experts like Dr Huang feel that the mass vaccination programmes launched in Western countries such as the US and the United Kingdom this month have placed added pressure on Beijing to prioritise its domestic population.

There is also the likelihood of an "immunity gap" developing, where Western nations achieve herd immunity from the virus before China, meaning these countries would be able to return to normalcy, while Beijing would have to keep up its strict control measures at considerable economic cost.

"It is not only epidemiologically bad for China, but also politically dangerous, because China would no longer be able to point to the ineffectiveness of Western countries in handling the outbreak to show the superiority of their political system," said Dr Huang.

Health authorities have said that China would be able to produce about 610 million vaccine doses this year and another one billion next year, but about 500 million vaccine doses have been earmarked to be shipped abroad.

Supposing two doses are needed for each vaccination, and that vaccine production capacities do not increase, that amount would not be enough for the 70 per cent of China's 1.4 billion people that Beijing needs to inoculate to reach herd immunity next year.

There are signs that Beijing recognises the risk of this happening, said Dr Huang, pointing to recent reports that China intends to vaccinate some 50 million people by Chinese New Year next year. But if it wants to achieve herd immunity ahead of Western countries, it could mean reneging on promises made to the developing world.

"If you fail to deliver the amount of vaccines you promise, that is going to tarnish Beijing's image. This is a dilemma that I think Chinese leaders will have to grapple with in the near future," said Dr Huang.

The incoming Biden administration could also frustrate China's outreach if the administration takes a more active stance in vaccine diplomacy, and sets aside a portion of its vaccines for developing countries.

Add a rapidly mutating virus into the mix of all these concerns and the only certainty is that Beijing's vaccine diplomacy is not going to be as simple as a shot in the arm.

https://www.straitstimes.com/opinion/chinas-vaccine-diplomacy-not-as-simple-as-shot-in-the-arm