U.S. health advisers endorsed a one-dose COVID-19 vaccine from Johnson & Johnson on Friday, putting the nation on the cusp of adding an easier-to-use option to fight the pandemic. The Food and Drug Administration is expected to quickly follow the recommendation and make Johnson & Johnson’s shot the third vaccine authorized for emergency use in the U.S. Vaccinations are picking up speed, but new supplies are urgently needed to stay ahead of a mutating virus that has killed more than 500,000 Americans. After daylong discussions, the FDA panelists voted unanimously that the benefits of the vaccine outweighed the risks for adults. If the FDA agrees, shipments of a few million doses could begin as early as Monday. More than 47 million people in the U.S., or 14% of the population, have each received at least one shot of the two-dose vaccines from Pfizer-BioNTech and Moderna, which FDA authorized in December. But the pace of vaccinations has been strained by limited supplies and delays because of winter storms.While early Johnson & Johnson supplies will be small, the company has said it can deliver 20 million doses by the end of March and a total of 100 million by the end of June. Johnson & Johnson’s vaccine protects against the worst effects of COVID-19 after one shot, and it can be stored up to three months at refrigerator temperatures, making it easier to handle than the previous vaccines, which must be frozen. EffectivenessOne challenge in rolling out the new vaccine will be explaining how protective the Johnson & Johnson shot is after the astounding success of the first U.S. vaccines. The two-dose Pfizer-BioNTech and Moderna shots were found to be about 95% effective against symptomatic COVID-19. The numbers from Johnson & Johnson’s study are not that high, but it’s not an apples-to-apples comparison. One dose of the Johnson & Johnson vaccine was 85% protective against the most severe COVID-19. After adding in moderate cases, the total effectiveness dropped to about 66%. Some experts fear that lower number could feed public perceptions that Johnson & Johnson’s shot is a “second-tier vaccine.” But the difference in protection reflects when and where Johnson & Johnson conducted its studies.Johnson & Johnson’s vaccine was tested in the U.S., Latin America and South Africa at a time when more contagious mutated versions of the virus were spreading. That wasn’t the case last fall, when Pfizer-BioNTech and Moderna were wrapping up testing, and it’s not clear if their numbers would hold against the most worrisome of those variants. Importantly, the FDA reported this week that, just like its predecessors, the Johnson & Johnson shot offers strong protection against the worst outcomes, hospitalization and death. Studying 2nd doseWhile Johnson & Johnson is seeking FDA authorization for its single-dose version, the company is also studying whether a second dose boosts protection. Panel member Dr. Paul Offit warned that launching a two-dose version of the vaccine down the road might cause problems. “You can see where that would be confusing to people thinking, ‘Maybe I didn’t get what I needed,’ ” said Offit, a vaccine expert at Children’s Hospital of Philadelphia. “It’s a messaging challenge.” Johnson & Johnson representatives said they chose to begin with the single shot because the World Health Organization and other experts agreed it would be a faster, more effective tool in an emergency. Cases and hospitalizations have fallen dramatically since the January peak that followed the winter holidays. But public health officials warned that those gains may be stalling as more variants take root in the U.S. “We may be done with the virus, but clearly the virus is not done with us,” Centers for Disease Control and Prevention director Dr. Rochelle Walensky said, speaking at the White House on Friday. She noted that new COVID-19 cases have increased over the past few days. While it’s too early to tell if the trend will last, Walensky said adding a third vaccine “will help protect more people faster.” More vaccines are in the pipeline. On Sunday, a CDC panel is expected to meet to recommend how to best prioritize use of the Johnson & Johnson vaccine.
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Day: February 26, 2021
New Zealand Prime Minister Jacinda Ardern said Friday her government is supporting a new project using drones designed to monitor and protect the Maui dolphin, one of the world’s rarest marine mammals. Maui dolphins are found only in a small stretch of ocean off the west coast of New Zealand’s North Island, and current estimates suggest there are only 63 adult members of the species left. The new Māui Drone Project is a one-year collaboration between the Ministry for Primary Industries (MPI), nonprofit wildlife technology organization MAUI63 and the World Wildlife Fund-New Zealand. The project is designed to use the small, unmanned vehicles to find and track Maui dolphins, fly over them without disturbing them, and collect data on their habitat, population size and other behaviors. Ardern told reporters the drones will allow government agencies and others to focus conservation efforts where they are needed most to protect the animals.”We have drawn basically geographical areas where we have restricted certain types of fishing, but this will help us understand where they are, their movements, where the extra protections are required,” she said. Maui dolphins are the smallest of the world’s dolphin species, measuring less than two meters long, and weighing up to 50 kilograms. Unlike other dolphins, they have distinctive round dorsal fins, and short snouts. They breed slowly, adding only one individual dolphin per year, and have relatively short lifespans, facts which may have contributed to their decline.
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International crime fighting agencies say organized crime groups have all the networks and methods needed to smuggle falsified, substandard and stolen COVID-19 vaccines across Africa.
Interpol crime intelligence analyst John-Patrick Broome said, as is the case in the rest of the continent, criminal gangs in East Africa import fake medicines from Asia, mostly China and India. The fake drugs often lack any active ingredients and many actually have harmful substances, he said.
“Illicit medications are primarily entering the market in eastern Africa through … avoidance of regulations, there’s violence-based criminality and there’s corruption as well, and corruption which is at a number of different levels,” Broome said.
China and India are expected to produce much of Africa’s vaccine supply. That’s already a “big red flag,” says Nigerian journalist Ruona Meyer, whose work has exposed government officials and pharmaceutical company executives working with criminals to distribute falsified medicines in West Africa. Both countries are known as sources for faked pharmaceuticals. Meyer says there won’t be enough vaccines, and as infection rates and deaths spike in some countries, criminals will introduce fakes into supply chains. FILE – A chemist displays hydroxychloroquine tablets in New Delhi, India, April 9, 2020.She points out they did that easily with chloroquine, when demand for the anti-malarial drug skyrocketed last year after it was touted as a coronavirus treatment.
“So, you had people who started producing fakes. You had people who started breaking down these routes. You had cases where these things were hijacked at ports. Again, they want to break that supply chain,” Meyer said.
Authorities throughout West and Central Africa seized large quantities of fake and substandard chloroquine. Police in Cameroon shut down several pharmaceutical manufacturers producing fake chloroquine.
“The infrastructure alone is mind-boggling, to be able to do all these things. Nobody does all these things if there is no demand,” she said.
One sign of the corruption sometimes found in medicine distribution is the 2015 conviction of two Dutch former United Nations consultants for rigging a contract for life-saving drugs in the Democratic Republic of Congo. A court in Britain found Guido Bakker and Siibrandus Scheffer guilty of accepting a bribe of more than $900,000 to steer a contract to a Danish pharmaceutical company. Lawyers Marius Schneider and Nora Ho Tu Nam represent some of the world’s biggest pharmaceutical companies when their products are faked in Africa.
FILE – An agent stands next to a container full of illegal and fake drugs seized by Ivorian authorities in Abidjan, Ivory Coast, Nov. 6, 2018.Ho Tu Nam said criminal organizations have been waiting eagerly for immunization programs to start, and for vaccine shortages.
“Now people are aware that the vaccine exists; people know it’s being rolled out in certain countries, and I think it’s a perfect time for those syndicates to come in and say, ‘We have the vaccine; you’re not getting it in the hospitals, you’re not getting it in your private clinics, so come to us.’” she said.
And they have been successful in the past. Schneider says groups dealing in black market vaccines do their best to make their products look legitimate.
“We have seen instances where NGOs … have been engaged in the distribution of these vaccines. These NGOs had as a mission to distribute real vaccines to the people. Employees on the ground in African countries were implicated in vaccine traffic,” Schneider said.
Investigators say often such cases are settled out of court, in confidential settlements. But in one known case, employees of a multi-national pharmaceutical company were caught helping a criminal network distribute fake vaccines in Africa.
Mark Micallef of the Global Initiative Against Transnational Organized Crime says North Africa could be a major entry point for falsified and substandard vaccines.
He said “uncontrolled” trafficking of fake medicines, such as the pain reliever tramadol, has been happening across the vast region for decades.
“Fake vaccines — I think there’s a big danger of that in the Maghreb itself, so unregulated territories in Libya, definitely. But, also in Tunisia and maybe border areas of Egypt, less so in Algeria, perhaps, but especially in the northern Sahel,” Micallef warned.
Criminals dealing in fake medicines exploit gaps in health services and this will be especially true of COVID-19 shots, and that, Micallef said, will make the crime very difficult to control in North Africa.
“This form of trafficking is tapping an actual health sector need. And the fear is that in the case of the vaccines, a similar scenario might unfold where there are shortages, especially in the border areas, that are preyed upon by criminal enterprise trying to fill that gap,” he said.
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Three new British studies show the Pfzier-BioNTech COVID-19 vaccine, which is considered a two-dose vaccine, reduced transmission of the virus after one dose, particularly in people who had previously tested positive.
One study conducted by Britain’s University of Cambridge Hospital and published Friday suggests a single dose of the Pfizer BioNTech vaccine can reduce by four times the number of asymptomatic COVID-19 infections. According to researchers, that indicates the vaccine could significantly reduce the risk of transmission of the virus from people who are asymptomatic, as well as protecting others from getting ill.
Lead researcher on the study, Cambridge University Hospital Infectious Disease Specialist Dr. Mike Weekes, said, “This is great news – the Pfizer vaccine not only provides protection against becoming ill from SARS-CoV-2 but also helps prevent infection, reducing the potential for the virus to be passed on to others.”
The study has not been peer reviewed but researchers say they published ahead of that review because of the urgent need to share information relating to the pandemic.
Two other studies, published late Thursday in the British medical journal The Lancet, indicate a single dose of the Pfizer-BioNTech vaccine is enough to protect people who have had COVID-19 from getting it again.
The studies were conducted by the University College London and Public Health England, and the Imperial College of London.
In other news regarding the Pfizer-BioNTech vaccine, the U.S. Food and Drug administration late Thursday said the vaccine can be kept at conventional freezer temperatures for up to two weeks, rather than the ultra-cold temperatures originally required for the vaccine.
The makers of the vaccine had applied for the approval last week, after their studies concluded the vaccine was still safe and effective when stored at conventional freezer temperatures. The ruling will make the vaccine far easier and less expensive to distribute and store.
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Violet light bathed the club stage as 300 people, masked and socially distanced, erupted in gentle applause. For the first time since the pandemic began, Israeli musician Aviv Geffen stepped to his electric piano and began to play for an audience seated right in front of him.“A miracle is happening here tonight,” Geffen told the crowd.Still, the reanimating experience Monday night above a shopping mall north of Tel Aviv night was not accessible to everyone. Only people displaying a “green passport” that proved they had been vaccinated or had recovered from COVID-19 could get in.The highly controlled concert offered a glimpse of a future that many are longing for after months of COVID-19 restrictions. Governments say getting vaccinated and having proper documentation will smooth the way to travel, entertainment and other social gatherings in a post-pandemic world.But it also raises the prospect of further dividing the world along the lines of wealth and vaccine access, creating ethical and logistical issues that have alarmed decision-makers around the world.’Left behind’Other governments are watching Israel churn through the world’s fastest vaccination program and grapple with the ethics of using the shots as diplomatic currency and power.Inside Israel, green passports or badges obtained through an app are the coin of the realm. The country recently reached agreements with Greece and Cyprus to recognize each other’s green badges, and more such tourism-boosting accords are expected.Anyone unwilling or unable to get the jabs that confer immunity will be “left behind,” said Health Minister Yuli Edelstein.“It’s really the only way forward at the moment,” Geffen said in an interview with The Associated Press.The checks at the club’s doors, which admitted only those who could prove they are fully vaccinated, allowed at least a semblance of normality.“People can’t live their lives in the new world without them,” he said. “We must take the vaccines. We must.”The vaccine is not available to everyone in the world, whether due to supply or cost. And some people don’t want it, for religious or other reasons. In Israel, a country of 9.3 million people, only about half the adult population has received the required two doses.There is new pressure from the government to encourage vaccinations. Israeli lawmakers on Wednesday passed a law allowing the Health Ministry to disclose information on people who have yet to be vaccinated. Under the policy, names can be released to the ministries of education, labor, social affairs and social services, as well as local governments, “with the purpose of allowing these bodies to encourage people to get vaccinated.”The government is appealing to the emotional longing for the company of others — in Israel’s storied outdoor markets, at concerts like Geffen’s, and elsewhere.“With the Green Pass, doors just open for you. You could go out to restaurants, work out at the gym, see a show,” read an announcement on Feb. 21, the day much of the economy reopened after a six-week shutdown.Then it raised a question at the center of the global quest to conquer the pandemic that has hobbled economies and killed nearly 2.5 million people: “How to get the pass? Go and get vaccinated right now.”Fraught ethical landscapeIt’s that simple in Israel, which has enough vaccine to inoculate everyone over 16, although the government has been criticized for sharing only tiny quantities with Palestinians in the occupied West Bank and Gaza.Prime Minister Benjamin Netanyahu said this week he intends to send excess vaccine to some of the country’s allies. Israel’s attorney general said Thursday night the plan has been frozen while he reviews the legalities.Most countries don’t have enough vaccine, highlighting the fraught ethical landscape of who can get it and how to lift the burden of COVID-19.“The core human rights principle is equity and nondiscrimination,” said Lawrence Gostin, a Georgetown University professor and director of the World Health Organization Collaborating Center on National and Global Health Law.“There’s a huge moral crisis in equity globally because in high-income countries like Israel or the United States or the EU countries, we’re likely to get to herd immunity by the end of this year,” he said. “But for many low-income countries, most people won’t be vaccinated for many years. Do we really want to give priority to people who already have so many privileges?”It’s a question dogging the international community as wealthier countries begin to gain traction against the coronavirus and some of its variants.Last April, the initiative known as COVAX was formed by the WHO, with the initial goal of getting vaccines to poor countries at roughly the same time shots were being rolled out in rich countries. It has missed that target, and 80% of the 210 million doses administered worldwide have been given in only 10 countries, WHO Director-General Tedros Adhanom Ghebreyesus said this week.Ghana on Wednesday became the first of 92 countries to get vaccines for free through the initiative. COVAX announced that about 600,000 doses of the AstraZeneca vaccine arrived in the African nation. That’s a fraction of the 2 billion shots the WHO aims to deliver this year.As those countries begin vaccinations, wealthier nations are starting to talk about “green passport” logistics, security, privacy and policy.The British government said it is studying the possibility of issuing some kind of “COVID status certification” that could be used by employers and organizers of large events as it prepares to ease lockdown restrictions this year.Prime Minister Boris Johnson said the policy could cause problems.“We can’t be discriminatory against people who, for whatever reason, can’t have the vaccine,” he said.Many countries around Europe are scrambling to develop their own vaccine certification systems to help revive summer travel, generating a risk that different systems won’t work properly across the continent’s borders.“I think there is huge potential for not working well together,” said Andrew Bud, CEO of facial biometrics company iProov, which is testing its digital vaccination passport technology within the U.K.’s National Health Service.But the technical knots around vaccine passports may be the easier ones to solve, he said.The bigger challenges “are principally ethical, social, political and legal. How to balance the fundamental rights of citizens … with the benefits to society.”
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U.S. lawmakers launched an investigation this week into the December 2020 SolarWinds hack that included a breach of many private and U.S. government computer systems. As VOA’s congressional correspondent Katherine Gypson reports, tech leaders are telling lawmakers the full scope of the breach is still not known. Camera: Adam Greenbaum Produced by: Katherine Gypson
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US President Joe Biden commemorated on Thursday the 50 millionth shot of the COVID-19 vaccine since his swearing-in, just days after the nation passed 500,000 coronavirus deaths. White House correspondent Patsy Widakuswara has this story.Producer: Barry Unger
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With internet access increasing in many emerging democracies, use of social media is changing the ways that candidates and voters interact. It’s also changing how the non-profit U.S.-based Carter Center assesses elections. As VOA’s Kane Farabaugh reports, monitoring online disinformation and threats to prevent political violence is a new front in the center’s democracy initiatives and is a focus ahead of elections in Ethiopia.Camera: Kane Farabaugh Producer: Kane Farabaugh
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U.S. lawmakers launched an investigation this week into the December 2020 SolarWinds hack that included a breach of many private and U.S. government computer systems. As VOA’s congressional correspondent Katherine Gypson reports, tech leaders are telling lawmakers the full scope of the breach is still not known. Camera: Adam Greenbaum Produced by: Katherine Gypson
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As countries kick off vaccination campaigns in Africa amid mistrust over COVID-19 vaccine efficacy, health ministers are among the first ones to take the shots. VOA’s Mariama Diallo reports on Senegal and Zimbabwe, two countries that began inoculating their populations using Sinopharm — the Chinese-made COVID-19 vaccine.
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