EUROPEAN Union gave approval on December 21 for the COVID-19 vaccine developed by Pfizer Inc and BioNTech SE, the latest regulatory go-ahead for the shot, while the United States authorised Moderna Inc’s vaccine on December 19, the second for the country and the first for the company worldwide.
The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has killed more than 1.7 million people worldwide:
WHO IS FURTHEST ALONG?
U.S. drugmaker Pfizer and German partner BioNTech are the COVID-19 vaccine trailblazers.
On Nov. 18, they became the first in the world to release full late-stage trial data. Britain was the first to approve the shot for emergency use on Dec. 3, followed by Canada on Dec. 9 and the U.S. Food and Drug Administration (FDA) on Dec. 11. Several other countries including Saudi Arabia and Mexico have also approved it.
The European Medicines Agency (EMA) approved the shot on Dec. 21 and India is accelerating its review.
The World Health Organization could decide whether to give its emergency use approval for the Pfizer candidate by the end of the year as part of its COVAX programme aimed at providing shots for poor- and middle-income countries.
WHO WILL APPROVE MODERNA NEXT?
Moderna became a close second to Pfizer in many countries after it released a full data analysis for a late-stage trial on Nov. 30 showing a 94.1% efficacy rate for its vaccine. Canada approved the shot on Dec. 23 and the EMA will do so on Jan. 6.
WHO ELSE IS IN THE RUNNING?
Britain’s AstraZeneca is seeking approval for its vaccine in Britain after announcing interim late-stage trial data on Nov. 23. It had an average efficacy rate of 70% and as much as 90% for a subgroup of trial participants who got a half dose first, followed by a full dose.
However, it is not clear how the regulator will deal with the different dosages in the efficacy data in its assessment. While India is conducting an accelerated review, it has asked for more data. AstraZeneca is also in discussions with the EMA, which is conducting a rolling review of the vaccine.
India is expected to make a decision on whether to approve for the two full-dose regimen of the shot, which was shown to be 62% effective in late-stage trials, soon. Its review does not include the more effective dosage, with 90% efficacy which was given to a small subgroup of volunteers in the trials.
U.S. drugmaker Johnson & Johnson plans to deliver trial data in January 2021, teeing it up for U.S. authorization in February if its shot is effective. It reduced the enrolment target for its clinical trial to 40,000 volunteers from 60,000 on Dec. 9, potentially speeding results which are tied to how quickly participants become infected.
U.S. firm Novavax is running a late-stage trial in Britain with data due in the first quarter of 2021. It expects to start a large-scale trial in the United States this month.
France’s Sanofi and Britain’s GlaxoSmithKline, however, announced a setback on Dec. 11 in their attempts to develop a vaccine. The drugmakers said it showed an insufficient immune response in older people in mid-stage trials and that they would start a new study in February.
WHAT HAPPENS IN THE TRIALS?
The companies typically test their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.
HOW ARE VOLUNTEERS INFECTED?
The trials rely on subjects becoming naturally infected with COVID-19, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger the first analysis of their data.
HOW WELL ARE THE VACCINES SUPPOSED TO WORK?
The World Health Organization ideally wants to see at least 70% efficacy. The FDA wants at least 50% – which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The EMA has said it may accept a lower efficacy level.
WHAT ABOUT RUSSIA AND CHINA?
While Pfizer’s shot was the first to be rolled out following the publication of full Phase III trial data, Russia and China have been inoculating their citizens for months with several different vaccines still undergoing late-stage trials.
Russia said on Nov. 24 its Sputnik V vaccine, developed by the Gamaleya Institute, was 91.4% effective based on interim late-stage trial results. It started vaccinations in August and has inoculated more than 100,000 people so far.
India plans to make 300 million of the shots next year and Argentina has given the green light for emergency use of the shot, with some 300,000 doses arriving in the country on Dec. 24.
China launched an emergency use programme in July aimed at essential workers and others at high risk of infection. It has vaccinated about one million people as of mid-November using at least three shots – two developed by the state-backed China National Biotec Group (CNBG) and one by Sinovac Biotech.
Trial data on a COVID-19 vaccine developed by China’s Sinovac Biotech has varied: interim data from a late-stage trial in Turkey showed its CoronaVac shot is 91.25% effective, while researchers in Brazil say the shot was more than 50% effective.
The United Arab Emirates, meanwhile, said on Dec. 9 that one of the CNBG vaccines was 86% effective based on interim results from a late-stage trial in the Gulf Arab state.
Source – Thomson Reuters Foundation
SOUTH Africa has identified a new variant of the novel coronavirus, which authorities believe is driving a surge in COVID-19 infections that could overwhelm its healthcare system.
Several countries, including Britain which has found the mutant variant in cases linked to South Africa, have banned flights from South Africa, disrupting holiday travel and frustrating tour operators.
WHAT IS THE NEW VARIANT?
The new variant, referred to as 501.V2, was discovered by a network of scientists around South Africa who have been tracking the genetics of the SARS-COV-2 virus.
The variant appears to be focused in the south and southeast regions of the country and has been dominating findings from samples collected since October, they say.
First identified in Nelson Mandela Bay, along South Africa’s east coast, it spread rapidly to other districts in the Eastern Cape, and to the Western Cape and KwaZulu Natal (KZN) provinces.
Scientists say the variant is different from others circulating in South Africa because it has multiple mutations in the important “spike” protein that the virus uses to infect human cells.
It has also been associated with a higher viral load, meaning a higher concentration of virus particles in patients’ bodies, possibly contributing to higher levels of transmission.
Between 80% and 90% of new cases in the country are carrying the mutant variant, according to health authorities.
ARE THE CONCERNS JUSTIFIED?
All viruses, including the one that causes COVID-19, change over time, and there have been hundreds of variations of this virus identified worldwide.
South African scientists say there is no clear evidence at this stage that this variant is associated with more severe disease or worse outcomes. However, it does appear to spread faster than previous iterations.
“What has happened with the sheer number of infections growing very fast is that’s overwhelmed really fast the health care system,” said Professor Tulio de Oliveira, director of the KZN Research Innovation and Sequencing Platform (KRISP), who helped conduct genome sequencing on South Africa’s mutant variant. “And when that happens, we have a big spike of increased mortality.”
The positivity rate – or the percentage of all coronavirus tests performed that are actually positive – stood at 26% as of Dec. 23, around double the average rate of infection before December, when the virus showed signs of waning.
In the first wave of infections, which peaked during the winter months between June and July, the positivity rate reached as high as 27%.
“The rate of spread is much faster than the first wave and we will surpass the peak of the first wave in the coming days,” health minister Zweli Mkhize said on Wednesday.
IS IT DIFFERENT TO THE UK VARIANT?
The variants reported by South Africa and the UK share a common change in the spike protein that may make them more infectious. But they are different variants, and sequence analysis revealed that they originated separately, the World Health Organization said.
Dr Andrew Preston, reader in microbial pathogenesis at the University of Bath, said, “The ‘South African’ variant is distinct from the UK variant, but both contain an unusually high number of mutations compared to other SARS-CoV-2 lineages.”
WILL COVID-19 VACCINES PROTECT AGAINST THIS VARIANT?
South African authorities say it is too early to say whether the vaccines currently being deployed in Britain and the United States, or other COVID-19 shots in development, will protect against the new variant.
Vaccine developers including AstraZeneca, BioNTech and Moderna Inc said this week that they expect their shots to still work against the UK variant.
Source – Thomson Reuters Foundation
EVEN before COVID-19 struck, the women stitching clothes at Ethiopia’s Hawassa industrial park were among the world’s worst-paid garment workers – many making less than $30 per month.
Today, pay cuts and forced overtime have become common in short-staffed factories abandoned by hundreds of former employees – some too scared of catching the coronavirus to return, several workers told the Thomson Reuters Foundation.
Tigist, a 20-year-old seamstress, said some of her colleagues had not come back to Hawassa after they were furloughed in the early months of the pandemic, as the global garment industry was hammered by cancelled orders.
In recent months, bosses eager to recover lost business have been forcing the remaining workers to pick up the slack, Tigist – whose name has been changed to protect her identity – and other workers said.
“We had to work (more) to fill in the gap,” Tigist said in the tiny, bare room she rents with another worker for 275 birr (about $7) per month each – eating up almost half her monthly salary of 650 birr.
“We fear catching the virus too but we must continue because we don’t have any other option,” she said, adding that she had to work to avoid being a “burden” to her poor family who live in a southern village.
Since coming back from furlough, she said she has been working an extra six hours per week – work for which she has not been paid, instead being given occasional $0.13 top-up cards for her mobile phone.
At least five other women reported similar experiences since factories reopened.
They said they worked for manufacturers including KGG Garments PLC and Indochine Apparel PLC, which supply big brands such as The Children’s Place and Levi Strauss & Co.
A manager at KGG Garments PLC and the head of human resources at Indochine Apparel PLC denied the workers’ allegations of unpaid, forced overtime and said their factories had not closed during the pandemic.
Fitsum Ketema, general manager of the Hawassa Industrial Park, said “there are no such practices in our park”.
“Our companies are running their business respecting the law of the country,” Ketema said in a text message.
The Children’s Place and Levi Strauss & Co did not respond to requests for comment.
LOWEST PAID
More than a dozen industrial parks were built in Ethiopia in recent years as part of ambitious plans to turn the poor, mainly agrarian nation into a manufacturing powerhouse, attracting investors with tax breaks, cheap loans and labour costs.
The Hawassa industrial park, which lies some 275 km (170 miles) south of the capital, Addis Ababa, was inaugurated in 2016 and employed about 28,000 workers before the outbreak.
Most factories at the park are now running at pre-pandemic capacity again.
Crowds of women – many not wearing facemasks – could be seen walking arm-in-arm out of the park at the end of their shift one day last month.
Some were new recruits, recently hired to replace those who did not come back from furlough – some fearing the virus, others deterred by the harsh working conditions.
Campaigners have denounced slavery-like conditions and low wages in parks where garment workers, mostly women, are the lowest paid in the world, according to a 2019 report by the New York University Stern Center for Business and Human Rights.
“The fact that these workers are being paid such miserable wages … really enhances their vulnerability to hunger, to other forms of labour abuses,” said
Penelope Kyritsis, strategic research director at the U.S.-based Worker Rights Consortium monitoring group.
BASIC NEEDS
Workers who were in Hawassa when the coronavirus crisis began said they have been struggling to meet their basic needs for most of the year – despite government measures aimed at protecting them.
Ethiopia declared a five-month state of emergency in April to fight the coronavirus and mitigate its impact, prohibiting companies including clothing factories from laying off workers despite significant sales and order reductions.
Hundreds of workers employed in Hawassa in January 2020 were furloughed or terminated during the pandemic, according to a phone survey of 3,896 female garment workers which was conducted between April 28 and July 1.
Workers interviewed by the Thomson Reuters Foundation said they were furloughed on reduced pay, forcing some to skip meals or take on loans to buy food. Most live in slums near the park, sharing small rooms often without access to safe water.
Tigist said she received 450 birr ($11.65) per month – two thirds of her normal wage – and struggled to make ends meet so went home to her village until her factory reopened.
Others, like Birtukan, 24, told of having their wages docked since they returned from a 21-day layoff.
She said her employer had deducted a monthly food allowance from pay packets – equivalent to a 20% pay cut. They also decreased the incentive pay that workers earned when they hit the target output.
When she and colleagues complained, managers told them they could leave if they were unsatisfied – a common practice to discourage workers from complaining.
“We were told that we should be patient,” Birtukan, whose name has also been changed to protect her identity, said as she breastfed her baby.
Campaigners and unionists said establishing a statutory minimum wage would help protect workers from such abuses, though the government’s reluctance and COVID-19 have halted the process.
The pandemic has also made it more urgent to establish trade unions, which are long overdue in Hawassa and other industrial parks, according to campaigners.
“The more workers are organized, the more chances they can get to solve problems that arose because of the pandemic,” said Angesom Gebre Yohannes, head of the Industrial Federation of Ethiopian Textile, Leather and Garment Worker Trade Unions.
Yet for some garment workers such as Birtukan, the possibility of quick improvements appear slim for as long as the pandemic drags on.
“I’m not sure when it will be back to normal,” she said. “If the pandemic persists and the company doesn’t get profit, what do you expect?”
Source – Thomsons Reuters Foundation.
PHARMACEUTICAL companies should sell COVID-19 vaccines to African countries at discounted rates and allow them to be produced locally to potentially cut costs, according to the head of the continent’s disease control body.
Africa is aiming to vaccinate up to 60% of its 1.3 billion people in the next two years, but may need several years of inoculations, John Nkengasong, director of the Africa Centres for Disease Control and Prevention (CDC) told reporters.
How frequently people will need vaccinations against COVID-19 remains uncertain, he said.
“Because of this, local manufacturing becomes imperative so that we can meet our goals,” he said.
Many African states are relying on COVAX, a global COVID-19 vaccine allocation plan co-led by the World Health Organization (WHO), which is working to lower prices for poor and middle-income countries.
But the Africa CDC expects to receive only 20% of its vaccine needs through COVAX, and also needs money to distribute the vaccine.
“The COVAX facility does not take care of delivery, it takes care of the buying of the vaccines. But the greatest challenge for any vaccination programme is how do you deliver it to the needy in a timely fashion,” Nkengasong said,
He added the continent was working with Afreximbank and the World Bank to see how to raise funds to buy and deliver vaccines.
In November, South African President Cyril Ramaphosa, who is also the chairperson of the African Union, said $12 billion was needed for the vaccination programme.
On Thursday, GAVI, a vaccines alliance that co-leads COVAX with the WHO, said COVAX was on track with its goal to secure 2 billion COVID-19 vaccine doses by the end of 2021.
“COVAX has met its initial fundraising target and is making excellent progress in negotiating deals with manufacturers,” said Thabani Maphosa, a managing director at GAVI.
The Africa CDC said on Thursday a survey it conducted with the London School of Hygiene and Tropical Medicine showed nearly 80% of Africans would take a COVID-19 vaccine.
Source – Thomson Reuters Foundation.