WHO investigators to scrap interim report on probe of COVID-19 origins: WSJ

(Reuters) – A World Health Organization team investigating the origins of COVID-19 is planning to scrap an interim report on its recent mission to China amid mounting tensions between Beijing and Washington over the investigation and an appeal from one international group of scientists for a new probe, the Wall Street Journal reported on Thursday.

In Geneva, WHO spokesman Tarik Jasarevic said in an email reply: “The full report is expected in coming weeks”.

No further information was immediately available about the reasons for the delay in publishing the findings of the WHO-led mission to the central Chinese city of Wuhan, where the first human cases of COVID-19 were detected in late 2019.China refused to give raw data on early COVID-19 cases to a WHO-led team probing the origins of the pandemic, Dominic Dwyer, one of the team’s investigators said last month, potentially complicating efforts to understand how the outbreak began.

The probe had been plagued by delays, concern over access and bickering between Beijing and Washington, which accused China of hiding the extent of the initial outbreak and criticized the terms of the visit, under which Chinese experts conducted the first phase of research.

The team, which arrived in China in January and spent four weeks looking into the origins of the outbreak, was limited to visits organized by their Chinese hosts and prevented from contact with community members, due to health restrictions. The first two weeks were spent in hotel quarantine.

(Reporting by Aishwarya Nair in Bengaluru and Stephanie Nebehay in Geneva; Editing by Chizu Nomiyama and Bernadette Baum)

COVAX vaccine program to deliver 237 million doses to 142 nations by end-May

GENEVA/LONDON (Reuters) – The COVAX vaccine-sharing program said on Tuesday it will deliver 237 million doses of AstraZeneca’s COVID-19 shot to 142 countries by the end of May as it steps up the global roll-out of its vaccine supplies.

The timeline for the delivery of doses, made by AstraZeneca and by India’s Serum Institute, will be split into separate two-month schedules, COVAX said in a statement, with the first in February-March and the second in April-May.

“These timelines are dependent on a variety of factors including national regulatory requirements, availability of supply, and fulfillment of other criteria such as validated national deployment and vaccination plans,” the statement said.

COVAX is the World Health Organization-backed program to provide vaccines for poor and middle-income countries. It began its roll-out last week with the first deliveries of shots to Ghana and Ivory Coast.

Hailing the campaign as an “unprecedented partnership,” WHO Director-General Tedros Adhanom Ghebreyesus said Angola, Cambodia, Democratic Republic of Congo and Nigeria could also expect deliveries of COVAX-supplied vaccines on Tuesday.

“This is an unprecedented partnership that will not only change the course of the pandemic but also change the way the world responds to future health emergencies,” Tedros told a joint media briefing with the U.N. Children’s Fund UNICEF, the GAVI vaccines alliance – which co-leads COVAX – and others.

Ghanaian President Nana Akufo-Addo told the same briefing that his West African country, which this week began its inoculation campaign with COVAX doses, aimed to vaccinate 20 million people by the end of 2021.

COVAX added in a statement that as well as the first round of allocations of the AstraZeneca vaccine, some 1.2 million doses of the Pfizer-BioNTech COVID shot were also anticipated for delivery in the first quarter of 2021.

(Reporting by Emma Farge and Stephanie Nebehay in Geneva and Kate Kelland in London; Editing by Mark Heinrich)

Global COVID-19 infections up for first time in seven weeks, WHO says

ZURICH (Reuters) – The number of new coronavirus infections globally rose last week for the first time in seven weeks, the World Health Organization said on Monday.

“We need to have a stern warning for all of us: that this virus will rebound if we let it,” Maria Van Kerkhove, the WHO technical lead for COVID-19, told a briefing. “And we cannot let it.”

WHO Director-General Tedros Adhanom Ghebreyesus said the rise in cases was “disappointing but not surprising” and urged countries not to relax measures to fight the disease.

It was too early for countries to rely solely on vaccination programs and abandon other measures, he said: “If countries rely solely on vaccines, they are making a mistake. Basic public health measures remain the foundation of the response.”

Tedros noted that Ghana and Ivory Coast became the first countries on Monday to begin vaccinating people with doses supplied by COVAX, the international program to provide vaccines for poor and middle-income countries.

But he also criticized rich countries for hoarding vaccine doses, saying that it was in everyone’s interest for vulnerable people to be protected around the world.

“It’s regrettable that some countries continue to prioritize vaccinating younger healthier adults at lower risk of diseases in their own populations, ahead of health workers and older people elsewhere,” Tedros said.

Mike Ryan, the WHO’s top emergency expert, said the global fight against the coronavirus was in a better state now than it was 10 weeks ago before the roll-outs of vaccines had begun. But it was too early to say the virus was coming under control.

“The issue is of us being in control of the virus and the virus being in control of us. And right now the virus is very much in control.”

(Reporting by John Revill, Vishwadha Chander, Manojna Maddipatla; Writing by Peter Graff; Editing by Alex Richardson, Dan Grebler and Giles Elgood)

Debilitating ‘long-COVID’ may have severe health, social impacts: WHO

By Kate Kelland

LONDON (Reuters) – Thousands of COVID-19 patients continue to suffer serious, debilitating and lingering symptoms many months after their initial bout of infection, with major social, health and economic consequences, European health experts said on Thursday.

Publishing a World Health Organization-led guidance report on the condition, often referred to as “long COVID” or “post-COVID syndrome,” experts said around one in 10 COVID-19 patients are still unwell 12 weeks after their acute infection, and many suffer symptoms for far longer.

“This is a condition that can be extremely debilitating. Those suffering from it describe a varying combination of overlapping symptoms… (including) chest and muscle pain, fatigue, shortness of breath … brain fog (and) many others,” said Martin McKee, a professor at the European Observatory on Health Systems and Policies who led the report.

Hans Kluge, the WHO’s European regional director, said long-COVID could have “severe social, economic, health and occupational consequences.”

“The burden is real and it is significant,” he said.

He urged health authorities to listen to patients’ concerns, take them seriously, and establish services to help them.

Growing evidence from around the world points to many thousands of people experiencing long-COVID. The condition appears not to be linked to whether a patient had a severe or mild infection.

An initial report by Britain’s National Institute for Health Research last year suggested long-COVID may be not one condition, but multiple syndromes causing a rollercoaster of symptoms affecting the body and mind.

Kluge noted that as with any new disease, much remains unknown about COVID-19.

“We need to listen and … understand. The sufferers of post-COVID conditions need to be heard if we are to understand the long-term consequences and recovery from COVID-19,” he said. “This is a clear priority for WHO (and) it should be for every health authority.”

WHO agrees compensation fund for serious COVAX vaccine side effects

By Kate Kelland

LONDON (Reuters) – The World Health Organization has agreed a no-fault compensation plan for claims of serious side effects in people in 92 poorer countries due to get COVID-19 vaccines via the COVAX sharing scheme, resolving a big concern among recipient governments.

The program, which the WHO said was the first and only vaccine injury compensation mechanism operating on an international scale, will offer eligible people “a fast, fair, robust and transparent process,” the WHO said in a statement.

“By providing a no-fault lump-sum compensation in full and final settlement of any claims, the COVAX program aims to significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process,” the statement said.

Questions of how compensation claims would be handled in the event of any serious COVID-19 vaccine side effects, which are likely to be very rare, had been a worry for countries due to get COVID-19 shots via the COVAX plan.

Countries funding their own COVID-19 vaccine procurement also plan their own liability programs.

The WHO-agreed plan, which has been under discussion for several months, is designed to cover serious side effects linked to any COVAX-distributed vaccines until June 30, 2022, to COVAX’s Advance Market Commitment-eligible economies – a group of 92 poorer states which includes most African and Southeast Asian countries.

The program will be financed initially from donor funding to the AMC as an extra charge on all doses of COVID-19 vaccines distributed through COVAX. Applications can be made via a portal at http://www.covaxclaims.com from March 31, 2021, the WHO said.

Seth Berkley, chief executive of the GAVI vaccine alliance which co-leads COVAX, said the agreement on the compensation fund was “a massive boost” for COVAX, which aims to secure equitable global access to COVID-19 vaccines.

“It helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through (COVAX),” Berkley said.

The WHO said it was also working with the insurance firm Chubb to secure insurance coverage for the program.

(Reporting by Kate Kelland; Editing by Alison Williams)

Indian vaccine makers say can quickly adapt to tackle variants

By Krishna N. Das and Neha Arora

NEW DELHI (Reuters) – Indian pharmaceutical companies Bharat Biotech and Biological E. Ltd said on Monday they could quickly rework their COVID-19 vaccine products to fight new variants once their genetic sequence is known.

In recent months, India has confirmed the presence of the variants first identified in Brazil, Britain and South Africa, which are believed to explain an upsurge in cases in the Indian states of Maharashtra and Kerala.

In all, India has reported more than 11 million coronavirus infections, the highest number in the world after the United States, and about 156,000 deaths.

“As we are seeing a lot of resurgence of cases, we are picking up samples from hotspots and clusters and we are trying to sequence them,” Nivedita Gupta, deputy director-general of the state-run Indian Council of Medical Research (ICMR), told the BioAsia conference.

ICMR and Bharat Biotech have collaborated to develop India’s first homegrown COVID-19 vaccine, which, along with another licensed from AstraZeneca and Oxford University, is being used in the country’s immunization campaign that has covered more than 10 million people since mid-January.

India is the world’s biggest maker of vaccines, and its companies have promised to produce billions of doses of COVID-19 shots.

Bharat Biotech Chairman Krishna Ella said his company would mainly need data from the ICMR or the World Health Organization on the genetic sequence of any variant to quickly make an effective vaccine.

Speaking at a conference organized by the state of Telangana, home to India’s vaccine hub Hyderabad, Ella said a product to tackle the South African variant could be made in 15 days and would not require any change to the manufacturing process.

Biological E. Managing Director Mahima Datla said there was no need to be “overly concerned” about the mutations.

“Eventually we don’t know which variant of the virus, which mutants will take over, but we think that it’s prudent to work on technologies that address the new variants as well,” she said.

Biological E., which is developing a vaccine with Houston’s Baylor College of Medicine and Dynavax Technologies, recently completed Phase 1/2 clinical trial in India, Datla said.

Its product uses the recombinant-protein technology in which a harmless agent is used to stimulate an immune response in cells.

“Once you know the variant, when it’s sequenced, it is fairly quick to deploy into a vaccine,” said Datla, whose company will also contract-manufacture Johnson & Johnson’s shot.

(Reporting by Krishna N. Das and Neha Arora; editing by Barbara Lewis)

Pfizer wants to store vaccine at higher temperatures, making deliveries easier

FRANKFURT (Reuters) – Pfizer Inc and BioNTech SE have asked the U.S. health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers, they said on Friday.

Approval by the Food and Drug Administration (FDA) could send a strong signal to other regulators around the world that may ease distribution of the shot in lower-income countries.

The companies have submitted new temperature data to the FDA to support an update to the current label that would allow vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks.

The current label requires the vaccine to be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.

The shot’s cold-storage requirements set off a scramble among U.S. states at the beginning of the rollout for dry ice, in which it can be stored temporarily when there are no specialized freezers available, for instance in rural areas.

Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, said the higher temperatures should “greatly expand the ability to use this vaccine in many parts of the world (or even the U.S.) that do not have the capacity for deep freeze storage”.

Pfizer/BioNTech’s vaccine, along with Moderna Inc’s two-dose shot, has already won U.S. emergency-use authorization and is being widely distributed as part of the country’s mass vaccination efforts.

The update from the drugmakers comes as two studies from Israel found that the vaccine greatly reduced virus transmission, and the shot was backed by two of the South African government’s top advisers.

The new data also will be submitted to global regulatory agencies within the next few weeks, the two companies said.

A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted.

“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” BioNTech Chief Executive Ugur Sahin said.

Deutsche Post, which has shipped COVID-19 vaccines to several European countries, Israel, Bahrain, Mexico and Singapore, among other states, said -25 degrees would provide some relief but transportation would still not be easy.

A spokeswoman said air freight would likely no longer require dry ice on board, increasing storage capacity per plane.

BioNTech has said it imposed long-term storage and transportation requirements of -70 degrees out of caution because it had started stability and durability tests on its vaccine relatively late.

Even though it launched its COVID-19 vaccine development program as early as January 2020, working on four compounds in parallel, it did not decide until July which of the four to proceed with, and only then started stability tests.

If approved, the less onerous storage requirements would provide significant logistical relief.

The World Health Organization’s COVAX global vaccine-sharing program has so far limited distribution of Pfizer-BioNTech vaccines to just a few countries, partly out of concern over a lack of infrastructure in developing nations.

The WHO said it was hopeful that eased requirements could broaden its reach.

“We are aware of reports of this and look forward to seeing the data. If proven correct, this could make rollout of the vaccine easier in all countries, and particularly in low-income ones,” it said.

Moderna’s product, which like Pfizer’s is based on so-called messenger RNA molecules, is already cleared for storage at -25 to -15 degrees Celsius.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Ludwig Burger in Frankfurt, John Miller in Zurich, Matthias Inverardi in Duesseldorf, Michael Erman in Maplewood, N.J. and Lisa Baertlein in Los Angeles; Editing by Shounak Dasgupta, Anil D’Silva, Jan Harvey and Nick Macfie)

Pfizer study deals new blow to South Africa’s vaccine hopes

By Alexander Winning and Wendell Roelf

JOHANNESBURG (Reuters) – Scientists will meet on Thursday to advise South Africa’s government on its next steps after a study suggested the dominant local coronavirus variant may reduce antibody protection from Pfizer’s COVID-19 vaccine by two-thirds.

The laboratory study, published in the New England Journal of Medicine, dealt a new blow to the country hardest-hit by the pandemic on the African continent.

The government and its advisers must weigh whether to wait for vaccines that might be more effective against the more infectious 501Y.V2 variant, or try to vaccinate people quickly to avert further infections and deaths.

South Africa had been counting on the Pfizer shot, developed with German partner BioNTech, to step up its vaccination program after administering the first Johnson & Johnson (J&J) doses on Wednesday.

Earlier this month, it placed AstraZeneca vaccinations on hold because of interim data showing its jab offered minimal protection against mild to moderate illness from the 501Y.V2 variant first identified late last year.

Officials are more confident about the J&J shot because it was shown to be effective in preventing severe illness in the local leg of a large global trial.

The detailed laboratory study published on Wednesday took into account all key mutations of the 501Y.V2 variant. A paper published in late January assessed the impact of only three key mutations of the variant on the Pfizer vaccine.

Scientists said that because the new study’s findings come from a laboratory, it is not easy to extrapolate what they might mean for the shot’s efficacy in the real world.

“Our scientists will be meeting to discuss it (the study) and they will advise the minister,” health ministry spokesman Popo Maja said.

Barry Schoub, a professor and chair of the Ministerial Advisory Committee on vaccines, said the committee would discuss the study alongside information on other COVID-19 vaccines.

Asked to comment on the findings, he said: “The Pfizer vaccine is enormously effective at 95%, so even if there is quite a significant reduction there still will be quite a bit of remnant efficacy left.”

“It is very likely that it will protect to a reasonable extent, certainly against severe illness and mild to moderate to some extent,” he said.

“STRONG ENOUGH”

Richard Mihigo, an immunization official at the World Health Organization’s Africa office, told a news conference the antibody response to the variant in the Pfizer study was “strong enough”.

Linda-Gail Bekker, co-lead investigator of the South African arm of J&J’s global trial, said she would recommend rolling out the Pfizer vaccine but monitoring it in the same way as the J&J shot, which is being administered in an “implementation study” targeting up to 500,000 health workers to further test it in the field.

“We should make sure we do see the effectiveness we (are) hoping for,” she told Reuters.

Health Minister Zweli Mkhize said on Wednesday South Africa was expecting 500,000 doses of the Pfizer vaccine initially and about 7 million doses by June.

A spokesman for regulator SAHPRA said Pfizer’s registration application was under review and declined further comment.

South Africa, with nearly 1.5 million cases and about 48,500 deaths, has recorded almost half the COVID-19 fatalities and over a third of confirmed infections in Africa. It lagged richer Western nations in launching its immunization campaign.

The government plans to vaccinate 40 million people – two-thirds of the population.

“Luckily there are a range of vaccines available and what we will do is work with the national authorities to understand the implications of this (study) and see what they need to do,” the WHO’s Africa director, Matshidiso Moeti, said.

(Reporting by Alexander Winning in Johannesburg and Wendell Roelf in Cape Town; Additional reporting by Kate Kelland in London, Ludwig Burger in Frankfurt and Aaron Ross in Dakar; Editing by Olivia Kumwenda-Mtambo, Angus MacSwan, Raju Gopalakrishnan and Timothy Heritage)

WHO sounds regional warning over Ebola outbreaks in Congo, Guinea

GENEVA (Reuters) – An outbreak of Ebola in Democratic Republic of Congo and Guinea poses a regional risk that requires exceptional vigilance, a senior World Health Organization official said on Monday.

Congo has confirmed four cases of Ebola since a resurgence of the virus was announced on Feb. 7 in Butembo, the epicenter of a previous outbreak that was declared over last June.

An Ebola vaccination campaign has begun in Butembo, in eastern DRC, the WHO said in a tweet on Monday. Separately, the West African country of Guinea declared a new Ebola outbreak on Sunday, with seven confirmed cases and three deaths.

“We have to be exceptionally vigilant, highly alert,” Mike Ryan, WHO’s top emergency expert, told a news briefing.

“This disease (Ebola) represents a regional risk”

The Ebola virus causes severe vomiting and diarrhea and is spread through contact with body fluids.

(Reporting by John Revill, John Miller, Michael Shields in Zurich, Kate Kelland in London, Editing by William Maclean)

WHO lists AstraZeneca/Oxford COVID-19 vaccine for emergency use

GENEVA (Reuters) – The World Health Organization (WHO) on Monday listed AstraZeneca and Oxford University’s COVID-19 vaccine for emergency use, widening access to the relatively inexpensive shot in the developing world.

A WHO statement said it had approved the vaccine as produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.

“We now have all the pieces in place for the rapid distribution of vaccines. But we still need to scale up production,” said Tedros Adhanom Ghebreyesus, WHO Director-General.

The listing by the UN health agency comes days after a WHO panel provided interim recommendations on the vaccine, saying two doses with an interval of around 8 to 12 weeks must be given to all adults, and can be used in countries with the South African variant of the coronavirus as well.

The AstraZeneca/Oxford shot has been hailed because it is cheaper and easier to distribute than some rivals, including Pfizer/BioNTech’s, which was listed for emergency use by the WHO late in December.

Nearly 109 million people have been reported to be infected by the novel coronavirus globally and more than 2.5 million have died, according to a Reuters tally.

Infections have been reported in more than 210 countries and territories since the first cases were identified in China in December 2019.

(Reporting by John Revill, John Miller, Michael Shields in Zurich, Kate Kelland in London, Editing by William Maclean)