THE VIRUS IS GLOBALIZATION

‘Fantastic moment’: Filipino nurse

injects historic COVID-19 vaccine 

to British grandma

ABS-CBN News

Posted at Dec 08 2020 05:33 PM

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Pinoy nurse May Parsons injected the Pfizer-BioNTech COVID-19 vaccine to the 90-year-old British grandmother, the first in the world who received the vaccine outside clinical trials. Screenshot from Reuters video

MANILA — The British ambassador to Manila on Tuesday lauded a Pinoy nurse after administering Pfizer-BioNTech's COVID-19 vaccine to the first person in the world who received it outside clinical trials. 

In a tweet, Ambassador Daniel Pruce said it was great news that Pinoy nurse May Parsons injected the vaccine to the 90-year-old British grandmother. 

The ambassador also thanked the Filipino medical frontliners in the United Kingdom who made an “enormous contribution” to the country’s National Health Service (NHS). 

“A fantastic moment! And great to see that the vaccine is administered by Nurse May Parsons from the Philippines - one of the many thousands of Filipino healthcare workers making such an enormous contribution to the #NHS,” Pruce said. 

In a separate tweet, British personality Piers Morgan also praised Parsons, who he said has been working for the NHS for 24 years. 

“How wonderful that this historic global moment happened in the UK, at University Hospital, Coventry,” Morgan said. 

Britain was the first country to begin mass inoculations on Tuesday with a shot developed by Pfizer and BioNTech.

British health minister Matt Hancock, meanwhile, said he hoped life would get back to normal beginning spring of next year, following the roll-out of a vaccine against coronavirus.

"Because we've been able to get this vaccination program running sooner than anywhere else in the world, we will be able to bring that date forward a bit. I have great hopes for summer 2021 and I hope we can lift restrictions from the spring," Hancock told the BBC.

Vaccine Nationalism Is Doomed to Fail


Countries seeking to inoculate their citizens at the expense of everyone else are chasing a false promise.

YASMEEN SERHAN7:06 AM ET

THE ATLANTIC

After nearly a year of waging a “war” on the coronavirus, many countries are poised to declare victory. Britain, which today became the first country to roll out the Pfizer and BioNTech vaccine, dubbed the start of its immunization program “V-Day,” echoing the language used to commemorate its win in World War II. Elsewhere, China and Russia have already begun distributing their own state-backed vaccines for domestic use. And although the United States has yet to grant regulatory approval to any of the vaccine candidates, Donald Trump was quick to claim the spate of positive vaccine news as his own.

Many of these vaccines, and the ongoing trials for potential alternatives, have benefited from huge levels of government investment—much of it coming from wealthy countries determined to secure their spot at the front of the line for when the vaccines are finally ready. To that end, billions of doses were reserved before any had been approved for use, with many countries claiming enough to inoculate their population several times over.

This “vaccine nationalism,” in which countries prioritize their domestic needs at the expense of others, may have helped accelerate efforts to develop such drugs, but it is already showing its limits. With wealthy countries claiming the lion’s share of prospective doses for themselves, and with global efforts to equalize vaccine distribution facing enduring unilateralism and limited resources, a coronavirus vaccine returning the world to something resembling “normal” could take considerable time—perhaps even longer than it needs to. (Many of the governments warning against the unilateral approach are striking their own bilateral deals with vaccine manufacturers, in an apparent effort to have it both ways.) Without equal vaccine distribution, public-health experts warn, the pandemic could continue to live on residually for years, bringing with it even more death and further economic collapse. If the virus remains endemic anywhere, it will continue to pose a threat everywhere.


To better understand the extent to which richer countries have dominated the prospective-vaccine supply, it helps to look at the numbers. According to the Duke Global Health Innovation Center, which is tracking vaccine procurement worldwide, high- and upper-middle-income countries have collectively reserved nearly 5 billion vaccine doses. These doses are largely the product of bilateral deals between governments and vaccine makers, known as “advance market commitments,” in which governments commit to purchasing doses up front in exchange for priority access once the vaccine is approved. The U.S., for example, has entered into at least six of these bilateral deals, totaling more than 1 billion doses—more than enough to inoculate the entire American population. The European Union, Britain, and Canada have each entered into seven bilateral deals, with the potential of securing enough doses to cover their populations two, four, and six times over, respectively, the Duke numbers show.

In doing so, their governments are ensuring that even if one or more of the vaccine trials fails, they’ll still have plenty of other vaccines to fall back on. Put another way, they are “basically buying themselves a ticket to the front of the queue,” Clare Wenham, an assistant professor of global-health policy at the London School of Economics, told me. (Though wealthy countries such as Spain and Canada have suggested that they would be willing to donate excess doses to nations that need them, that process isn’t so simple. Before rolling out a vaccine, countries need to be able to ensure that they can foot the bill in the event of unexpected side effects or other costly issues—a liability that many poorer nations might not be able to afford.)

Countries seeking to acquire enough doses to inoculate their population isn’t in itself the problem. Governments, after all, have a responsibility to ensure the safety of their citizens. Nor have these bilateral agreements been entirely negative. “It has infused an absolutely astounding amount of money and investment into the development and manufacturing of these vaccines,” Andrea Taylor, the assistant director of programs at Duke’s Global Health Innovation Center, told me.

The issue is that there isn’t an infinite supply of vaccines—at least not in the short term. Even with increased manufacturing capacity, it will take years before there are enough doses to meet global demand. So far, vaccine manufacturers are prioritizing which countries get them first on a first come, first serve basis.

Ugur Sahin, the co-founder and CEO of BioNTech, told the Financial Times that Pfizer and BioNTech would give precedence to countries where its vaccine has received regulatory approval—which includes Britain. Moderna, meanwhile, is expected to prioritize the U.S. market. AstraZeneca has said that its first doses will be earmarked for Britain, owing to its partnership with Oxford University. The French pharmaceutical giant Sanofi, which is still in the early stages of its vaccine development, pledged that it would give the U.S. priority access in honor of the country’s early investment (a promise that was later walked back after causing ire in France).

“The number of doses we can actually get out in the world is very limited,” Taylor said. “When high-income countries take a large slice of that pie, there’s less pie for everyone else.”

In an ideal world, the pie would be shared equitably across nations, ensuring that no country is precluded from access to these lifesaving resources. It’s a goal that COVAX, an international alliance established to ensure that all countries have equal access to the vaccine, believes it can achieve if countries are willing to work together. But cooperation of this kind hasn’t exactly been a hallmark of public-health crises, past or present: During the 2009 swine-flu outbreak, wealthy countries reserved huge numbers of vaccine doses for themselves, leaving low-income countries to rely on donations that would arrive much later. Today, countries are still reverting to those nationalist instincts by imposing export bans on face masks, ventilators, and other essential resources.

COVAX hasn’t been without success: More than 180 economies, about half of which are high-income, have signed on to the initiative. What’s more, it has reserved enough manufacturing capacity to produce more than 1 billion doses—a goal which it aims to double by the end of next year. But that production will take time, leaving the alliance with just 700 million doses in advance market commitments in the short term—a sum significantly smaller than the number of doses reserved by many wealthy nations, and far short of its goal of providing enough doses to inoculate at least 20 percent of participating countries’ populations.

This isn’t COVAX’s only challenge. For one, the U.S. and Russia have both opted out of the project—a decision that, in the case of Washington, was prompted by the participation of the World Health Organization, which the U.S. withdrew from this year. (Though President-elect Joe Biden has pledged that the U.S. will rejoin the institution under his administration, it’s not yet clear whether that intent will extend to joining COVAX.) Then there’s the paradox that participating in COVAX hasn’t precluded high-income countries from striking their own bilateral vaccine deals—efforts that fundamentally undermine the initiative’s goal of equal distribution.

“There seems to be no stipulation that they shouldn't be doing these bilateral deals, so there is a tension there in [terms of] sheer goals,” Tamaryn Nelson, an Amnesty International researcher on the right to health, told me. “Clearly one undermines the other.”

This go-it-alone approach doesn’t just impede COVAX. It also risks perpetuating harm to public health and the global economy. According to recent modeling by Northeastern University, proportional distribution of vaccines could avert nearly twice as many deaths as a vaccine distribution limited to only high-income countries. Further modeling conducted by the Rand Corporation concluded that inequitable vaccine distribution could cost the global economy up to $1.2 trillion in GDP. Conversely, if low- and middle-income countries were granted equal access, according to Rand, the cost to the global economy would be considerably less.

“A collective response … doesn’t just make moral sense—it makes scientific sense,” a spokesperson for the vaccine alliance Gavi, which leads COVAX with the WHO, told me in an email. “If rich countries monopolize vaccines at the outset, it will take us a lot longer, and many more people will die, than if we distribute on a global, equitable basis.”

If the pandemic has cast doubt on the ability of countries to implement a multilateral response to a global problem, that portends poorly for other shared crises—not least climate change. Both challenges require unprecedented collaboration. Both disproportionately affect low-income communities. Neither can be averted by any single nation on the basis of wealth alone.



YASMEEN SERHAN is a London-based staff writer at The Atlantic.

MORE STORIES


Britain’s Vaccine Nationalism TOM MCTAGUE


The Long Haul of Vaccine Results Is Just Beginning SARAH ZHANG


The Month the Pandemic Started to End JULIETTE KAYYEM

Read: The end of the pandemic is now in sight

David Frum: The coronavirus is demonstrating the value of globalization

AMNESTY INTERNATIONAL

A FAIR SHOT: ENSURING UNIVERSAL ACCESS TO COVID-19 DIAGNOSTICS, 

TREATMENTS AND VACCINES

8 December 2020, Index number: POL 30/3409/2020

The COVID-19 pandemic has caused a global public health and socio-economic crisis. But the rapid development of vaccines could strongly mitigate its impact and perhaps even bring much of this crisis to a close. However, pending questions around how these vaccines will be distributed, to whom they will become available and at what cost, still pose challenging human rights concerns. Drawing upon a range of international human rights laws and standards, this Amnesty International briefing lays out guidance for states and businesses to address these questions while fulfilling their human rights obligations and responsibilities.

View report in English

DOWNLOAD PDF

 Nursing staff at heart of COVID-19 vaccine rollout as first injections given today

8 DEC 2020

It’s a proud moment for the profession as nurses are the first to administer and receive the vaccine.


The biggest vaccine campaign in NHS history kicked off this morning with nurse May Parsons the first to administer the Pfizer COVID-19 vaccine in the UK following its clinical approval.

The eyes of the world were on May as she gave the jab to 90-year old Margaret Keenan at her local hospital in Coventry.

May, who has worked in the NHS for the last 24 years, said it was a huge honour to be the first person in the UK to deliver a COVID-19 jab to a patient.

“I’m just glad that I’m able to play a part in this historic day,” she said. “The last few months have been tough for all of us working in the NHS, but now it feels like there is light at the end of the tunnel.”

In Northern Ireland, where the first doses of the vaccine were given to those involved in delivering the vaccination programme, senior nurse Joanna Sloan was the first to receive the vaccine at Royal Victoria Hospital in Belfast.

In Scotland, deputy charge nurse Katie McIntosh was among the first to administer jabs to her health care colleagues at the Western General Hospital in Edinburgh.

Speaking about the momentous day, RCN Chief Executive & General Secretary Dame Donna Kinnair said: “I’m incredibly proud that nursing staff will be at the very heart of the rollout of the COVID-19 vaccine.

“Nursing staff know that with every vaccination they give, this dreadful situation moves that little bit closer to its end. This unprecedented rollout plan relies most heavily on nursing staff in all settings and they feel great responsibility and pride today."

The RCN has released guidance about the COVID-19 vaccine rollout and how it will affect nursing staff. This covers who should administer the vaccine and which groups will be prioritised to receive i

Covid-19 vaccines can cause side effects. 

But don’t let that stop you from getting the shots

THE PHILADELPHIA INQUIRER | Tuesday, December 8, 2020 

AP
A nurse prepares to administer the Pfizer-BioNTech covid-19 vaccine in London.

A friend of Paul Offit’s volunteered for one of the covid-19 vaccine trials but, like everyone who participated, was not told whether he was injected with a placebo or the real thing.

The morning after getting the second dose, the North Carolina man woke up feeling crummy, with a headache and overall fatigue, and immediately called Offit. He was elated.

“He said ‘Yes, I got the vaccine!’” recalled Offit, a prominent infectious-disease specialist at Children’s Hospital of Philadelphia.

The man’s unpleasant symptoms were a sign that the vaccine was working, said Offit, who spoke Wednesday on a webcast run by JAMA (the Journal of the American Medical Association). When his friend received the injections, cells in his immune system responded by sending out inflammatory warning signals, which in turn triggered the formation of antibodies and other customized defenses that would remain in his system should he ever encounter the actual virus.

But as with any vaccine, those inflammatory chemicals also can cause side effects. And therein lies the public health messaging challenge of the next few months.

Some people will experience side effects and conclude that the vaccine gave them covid. Wrong. With the three vaccines for which results have been revealed so far — made by Pfizer, Moderna, and AstraZeneca — that is biologically impossible, for reasons we’ll explain below.

Others may worry that the process was rushed, or that two of them consist of genetic molecules called messenger RNA — the first such vaccines that would be approved for general use. Fair questions. But the record speed in developing the drugs was made possible by massive government investment and technological advances that have been in the works for years — not because any corners were cut on safety, infectious-disease experts say.

Yes, some people will develop side effects. Most will be mild or moderate, disappearing within a day or two. There is no sign of any long-lasting complications. Given the alternative — risk of infection with a virus that, as Offit put it, “has brought us to our knees” — physicians say the vaccines are worth a bit of collateral unpleasantness.

Here’s what to expect.

The complete safety data have not yet been disclosed, but preliminary results are encouraging.

With the vaccine made by Cambridge, Mass.-based Moderna, no significant safety concerns were identified in the first 15,000 people to get the injections. Most reported side effects occurred after the second dose: fatigue (in 9.7% of recipients), muscle pain (8.9%), joint pain (5.2%), headache (4.1%), and redness at the injection site (2%). Fewer than 2% have reported a high fever.

Among those who received the Pfizer vaccine, a joint effort with German firm BioNTech SE, 3.8% reported fatigue and 2% suffered a headache. More details are expected to be announced Tuesday, two days before the data are reviewed by an advisory panel of the U.S. Food and Drug Administration (Offit is a member).

It is likely that some volunteers experienced more than one of these side effects, said Seth Welles, a professor of epidemiology at Drexel University’s Dornsife School of Public Health. In other words, we should not add up all those percentages to determine the likelihood of side effects. There is some overlap.

Still, let’s say a total of 15% of recipients feel pretty awful for a day or two after getting their second dose. That will be millions of people. An employer with essential workers should take care not to vaccinate everyone at once, should some of them need to stay home for a day.

But a day off work is worth the trade-off, said Neil O. Fishman, an infectious-disease specialist and chief medical officer at the Hospital of the University of Pennsylvania. Preliminary trial results suggest the Moderna and Pfizer vaccines prevent 95% of covid cases.

“I’ve seen what a world without vaccine looks like,” Fishman said. “I’ve seen the death, I’ve seen the toll on the economy. I’ve seen the impact on our doctors, our nurses, their families, and the impact on the educational system and our children. When I look at the data that we have, it is very clear to me that the benefits of these vaccines far outweigh the risks.”

Side effects from vaccines tend to emerge within a day or two — after a few weeks, at most. If any truly serious effects were to occur in the tens of thousands of volunteers in the various clinical trials, they would have been detected by now, said Welles, the Drexel epidemiologist.

It is possible that some rare side effect could emerge once larger numbers of people are vaccinated, say at a rate of 1 in 200,000 or 1 in a million, he said. But even in normal times, vaccine trials are conducted in far fewer than 100,000 volunteers, similar to what has happened this year.

And if you get sick after a vaccine, that is no proof that the injection was the culprit, Welles said. Establishing cause and effect is a question of math — is the apparent side effect happening any more often than in people who have not been vaccinated? — and biological plausibility.

The textbook example is Guillain-Barré syndrome, a neurological disorder that occurred in several hundred people who received a swine flu inoculation in 1976 and 1977 — a vaccine developed in response to an outbreak of swine flu at Fort Dix, in New Jersey.

Guillain-Barré occurs when the immune system attacks the “peripheral” nervous system — nerve cells outside the brain and spinal cord — leading to muscle weakness and even paralysis.

For every 100,000 people who were vaccinated, epidemiologists determined that one additional case of Guillain-Barré occurred above the usual rate of this rare condition. And the link between cause (a ramped-up immune response) and effect was medically plausible.

But most medical conditions have no connection to vaccines. Robert Wachter, chair of the department of medicine at the University of California-San Francisco, worries that people will blame the covid vaccines for entirely unrelated maladies such as cancer, heart attack and stroke. In a long thread on Twitter, he warned:

“The vaccines will have zero to do with any of them.”

Vaccine trials generally last for years. That’s mainly to see how well, and how long, recipients are protected against disease, though scientists also watch for side effects.

Participants in the covid vaccine trials will be followed for years, too. So how can scientists say already that the injections worked?

Call it the silver lining of living in a pandemic.

In normal times, it can take many months for enough cases of a disease to occur so that statisticians can determine whether people who get vaccinated are less likely to get sick than those who receive a placebo. But as covid case numbers surged this fall, the answers came a lot faster.

In the case of Moderna, for example, 95 cases of disease were identified by mid-November out of 30,000 trial participants. In 90 cases, the person got the placebo — dramatic enough for researchers to conclude that the vaccine prevented most cases of disease.

The unusual speed with which these vaccines were developed was made possible for other reasons, too. Ordinarily, a drug company might wait months, even years, in between various regulatory hurdles before deciding to invest in manufacturing a vaccine.

But investments by multiple governments, such as the Trump administration’s Operation Warp Speed, took much of the business risk out of the equation. Drug makers began gearing up months ago to make the vaccines in case they worked.

Lastly, technology speeded the process. The first two companies to report results, Pfizer and Moderna, made their vaccines with molecules called messenger RNA. They contain genetic instructions for human cells to make the “spike” protein: the little protrusions that form the namesake corona around each coronavirus particle.

Traditional vaccines consist of whole viruses that have been weakened or inactivated, prompting the immune system to make antibodies and other defenses called T-cells. But the Pfizer and Moderna results indicate that the spike protein alone is enough to prompt this protective response.

And by itself, a protein cannot cause infectious disease. “It is impossible” for these vaccines to cause covid, said Fishman, the Penn physician.

The vaccine made by AstraZeneca, the third company to report results, delivers instructions for the spike in a different way: carried by another virus called an adenovirus. Those viruses, too, are unable to cause disease in humans, much less covid itself.

If approved, the Pfizer and Moderna products will be the first RNA vaccines to be administered to the general public. But the basic science behind them has been going on for years, including a major hurdle that was cleared in 2005 by two of Fishman’s Penn colleagues, immunologist Drew Weissman and Katalin Karikó, who is now at BioNTech.

The molecules are well-tolerated by the human body. And in any event, they don’t stick around. Once it is used to make a protein, RNA is rapidly degraded. And it can’t become part of your DNA.

Fishman is convinced the approach is rock-solid.

“To me, the most important measure of a vaccine is: Would I give it to my family?” he said. “I will give this vaccine to my wife and my children, and to me as soon as it is available.”

#SPUTNIKV

A ‘restricted’ free-for-all Russia’s coronavirus vaccine is rolling out in Moscow to risk groups, but hospitals are actually inoculating anyone who wants it, due to low demand driven by safety concerns

December 8, 2020
Source: Meduza

Maxim Shipenkov / EPA / Scanpix / LETA

Last week, Vladimir Putin ordered health officials to begin rolling out Russia’s coronavirus vaccine, Sputnik V, on a mass scale to people in certain risk groups — namely, doctors, teachers, and others most likely to come into contact with infected persons. Despite these restrictions, officials in and around Moscow (where the vaccine has been made available first) have been administering the shots to virtually anyone who wants one, learned Meduza special correspondents Svetlana Reiter and Liliya Yapparova, who also discovered a special chat group on Telegram that contains instructions explaining how to get Sputnik V, even if you’re not in a risk group.

Russia’s Health Ministry and city officials in Moscow have been clear about who, technically speaking, can get Sputnik V, the country’s first vaccine against the coronavirus. The eligible risk groups include health workers, teachers, “workers in the fields of public transportation, trade, and food,” law enforcement, and social workers, as well as salon workers, dry cleaners, bank tellers, and security guards. Also, students and military conscripts.

According to instructions from Mayor Sergey Sobyanin’s office, Muscovites hoping to get inoculated against COVID-19 need to bring their passport, health insurance policy number, and documentation proving their employment in one of the identified fields.

Spokespeople for Russia’s Health Ministry told Meduza that they plan to move doctors and teachers to the front of the vaccine line. An official in the federal government with knowledge of Sputnik V’s rollout also told Meduza that each region across the country will receive roughly 17,500 doses of the vaccine to begin mass inoculations.

Sputnik V’s chief developer, Denis Logunov, told Meduza that the vaccine still hasn’t completed its Phase III trial, meaning that it cannot yet be made available to the general public. The drug currently has only “limited” approval, which allows health officials to vaccinate only people in certain risk groups, Logunov explained.

So far, the only published data from Sputnik V’s completed clinical trials come from the vaccine’s combined Phase I-II trial and its 20 participants. “We have no [detailed, published] data on how this vaccine will affect the body, shall we say, in the long run,” says Svetlana Zavidova, the executive director of the nonprofit Association of Clinical Trials Organizations. “And we still have no data about the drug’s effectiveness. We can’t even assess the risk of widescale use,” she warns.

Though the concrete data is still lacking, the Russian authorities appear to be confident in the vaccine. Sources in the Health Ministry and at the Gamaleya Research Institute (which developed Sputnik V) told Meduza that researchers plan to publish their provisional results before the year’s end in an authoritative international medical journal.

Not everyone, however, is leaping at the opportunity to get vaccinated before the clinical trials are done. Dmitry Belyakov, the head of an independent union for first responders, told Meduza that his supervisors offered him first access to Sputnik V, but he declined. “Some people signed up and others didn’t want it. It’s a personal thing and management didn’t pressure anyone,” Belyakov says.

In and around Moscow, mass vaccinations against COVID-19 are already underway. Doctors, teachers, and others in risk groups, however, aren’t being prioritized — the shots are going to anyone who wants them. 

Telegram and the vaccine

On December 2, just hours after President Putin’s announcement that Russia would begin mass vaccinations against the coronavirus, a chat group on the instant messaging platform Telegram appeared called “Civil Vaccination” — later renamed “Civil (Mass) Vaccination Sputnik V (GamCovidWak)” — where one of the first messages contained surprisingly detailed instructions explaining how Muscovites could get inoculated immediately, regardless of their profession. For example, one message told people to visit a hospital in the town of Khimki and ask for “Head Nurse Olga Pavlovna,” who is allegedly responsible for doling out the facility’s Sputnik V. Civil Vaccination lists another six hospitals in and around Moscow where the coronavirus shot is available.

According to the Telegram channel, doctors are eager to vaccinate groups of five people at once because Sputnik V is shipped in five-dose ampoules. The chat group’s members quickly started organizing themselves into groups of five to make it easier for hospitals to vaccinate them all at once. “As soon as you get five [people] together, the vaccine is thawed in 20 minutes and they give it to you,” says the channel in its instructions.

In hospitals outside the city — in Nakhabino, Krasnogorsk, Khimki, and Reutov — health workers are saying openly that Sputnik V is available to anyone, regardless of profession, despite the fact that the region’s Health Department insists that the vaccine is restricted to people in risk groups until December 15.

Before Meduza published this story, roughly 400 people had joined the Civil Vaccination channel. (The chat group was closed after this story was released.) Members compared the lines for vaccination at different hospitals, shared photos of vials containing Sputnik V, and discussed its side effects. The channel’s community also debated rumors about mass vaccinations “of everyone, including civilians,” at Defense Ministry facilities. Here and there, someone posted messages trying to buy the vaccine from others. “Money doesn’t help if you don’t know where to pay. If you know where, please send me a message. Seriously,” wrote a chat-room administrator.

Meduza was unable to corroborate reports that Russia’s coronavirus vaccine is for sale illegally, but a source with ties to Sputnik V’s developer says there is a black market for the drug. “The doctors who don’t want to get the shot are selling their doses for 100,000 rubles [$1,350]. Maybe you don’t believe in the vaccine, and you could give your dose to a nurse, but no,” says Meduza’s source. 

Sergey Kiselyov / “Moskva” News Agency
“It’s not a problem”

Six individuals who are not in any of the designated risk groups told Meduza that they managed to get the coronavirus vaccine at hospitals in and around Moscow between December 5 and 7. These people say they were asked only for their identification and medical insurance cards. One man says he even informed the hospital openly that he isn’t in a risk group. “They said there weren’t many people yet, so it wasn’t a problem,” the hospital told him.

Meduza’s own correspondent managed to register for Sputnik V at a clinic in Khimki with just a name and age. The nurse never asked for proof of residency or profession. During registration, the clinic later confirmed that the vaccine was being offered without restrictions. Meduza also verified that the vaccine was available to the general public at a hospital in Krasnogorsk that was recommended by the Civil Vaccination chat group, but another facility listed by the group in Zvenigorod said its supply of Sputnik V was meant only for doctors and teachers.

Even the hospitals that do ask vaccine patients to list their professions apparently don’t require documentation. According to reports in the Telegram group and based on the experience of a Novaya Gazeta correspondent, it’s enough simply to tell the nurses that you’re a teacher or even that you occasionally volunteer with children. 

A vaccination against research

Moscow’s uncontrolled, mass COVID-19 immunization campaign threatens to damage the clinical trials of coronavirus vaccines in Russia, a source with ties to Sputnik V’s developers told Meduza, explaining that control subjects who received a placebo might get vaccinated independently, outside the trial study, thereby corrupting the clinical results. Meanwhile, test subjects who receive a coronavirus vaccine but then proceed with another immunization (just to be sure) are potentially endangering themselves.

According to reports on Civil Vaccination, participants in coronavirus vaccine trial studies have found it impossible to get the immunizations now offered to the public because their names appear blacklisted in Russia’s State Unified Medical Information and Analytical System. Individuals who have formally exited clinical trials, however, are entitled to receive Sputnik V, if they belong to one of the designated risk groups.

Local clinics in Moscow, however, don’t have access to these lists of vaccine-study participants, and some of these patients have managed to get shots outside the trial to ensure that they’ve been immunized against COVID-19. Meduza learned about three such cases. On Telegram, some acknowledged that they joined Sputnik V’s clinical trials not to help the drug’s development, but to get first access and return to some semblance of their lives before the pandemic. With the vaccine now available publicly, they want it again, just in case they received a placebo in the Phase III trial.

Sergey Kiselyov / “Moskva” News Agency

When asked for a comment about the coronavirus vaccine’s rollout in Moscow, the Russian Direct Investment Fund (the sovereign wealth fund sponsoring Sputnik V’s development) referred Meduza to Russia’s Health Ministry, which has not responded. A source with ties to the vaccine’s developers stressed to Meduza that Sputnik V’s creators have no control over Russia’s immunization process; rules prohibit researchers from contacting the doctors now administering the vaccine.

Doctors and Sputnik V

Despite Sputnik V’s apparently wide availability around Moscow, not all the local medical workers say they’ve been offered the vaccine. One paramedic told Meduza that she and her colleagues haven’t heard about access to the drug. “Maybe they’re [only] vaccinating doctors from the ‘red’ zones,” she guessed, alluding to the areas throughout the capital where COVID-19 infections have spiked. Even if she’s offered Sputnik V, however, she says she’ll decline, having soured on Russian-made vaccines after a bad experience with a domestic flu shot: “There are good guys at the Gamaleya [Research Institute], but they were under pressure — they were rushed. Faster, faster, they said.”

Oncologist Mikhail Laskov told Meduza that he’s waiting to read the published clinical data on Sputnik V’s effectiveness before he agrees to be vaccinated. “Everything I know [about the drug] is from press releases, and that’s not enough for me to make a decision,” Laskov says.

A source in Mayor Sobyanin’s office confirmed to Meduza that many of the city’s doctors and teachers have been hesitant to sign up for Sputnik V. At the same time, a source close to the management at a hospital in Lapino now treating coronavirus patients says most of the staff members have already been vaccinated.

“Nobody wants to wait forever”

Elena Romanova, the spokeswoman for Moscow’s Regional Health Department, assured Meduza repeatedly that the vaccine’s rollout prioritizes teachers, health workers, public service workers, and housing and utility professionals. She could not, however, explain why several vaccination centers around the capital have offered Sputnik V to individuals outside these risk groups and sometimes to people registered in other regions. Romanova also declined to say if hospitals are verifying that patients aren’t also participants in clinical trials before administering Sputnik V.

Romanova’s department has reported that there are now roughly 30,000 medical workers in the Moscow region tending to patients infected with COVID-19, but she declined to say how many of these people have been vaccinated against the disease. Romanova also declined to say how many doses of Sputnik V are available locally. On December 7, Governor Andrey Vorobyov said the region had already inoculated 5,000 people.

Moscow’s Municipal Health Department did not respond to Meduza’s inquiries.

The fact that Sputnik V ampoules come bundled in five doses, a federal official familiar with Russia’s vaccination program confirmed to Meduza, incentivizes health workers to distribute the drug widely. “What happens is you get one doctor or teacher and nobody wants to wait, so they open it up and give it to anyone who wants it, so nothing is wasted. They don’t pour it down the drain, thank God,” says Meduza’s source.

“The main thing for us is to make a plan,” a nurse distributing the coronavirus vaccine at one of Moscow’s clinics told Meduza. “They’ve delivered it, so we administer it. Nobody wants to wait forever for people in the risk groups [to show up], and we’ve got to file our reports.”

Story by Liliya Yapparova and Svetlana Reiter, edited by Pavel Merzlikin

Abridged translation by Kevin Rothrock

First dose of Chinese COVID-19 vaccine caused a headache, says Turkish volunteer recipient

The first dose of the COVID-19 vaccine made in China caused a headache, said the volunteer recipient, President of Akdeniz University Prof. Özlenen Özkan. The second dose reportedly had no side effects.

Tuesday December 08 2020 


Duvar English

The COVID-19 vaccine made in China caused a daylong headache after the first dose, and no side effects after the second dose, said volunteer recipient, Akdeniz University President Prof. Özlenen Özkan.

"I had a daylong headache with the first dose but no serious side effects with the second dose. We don't know what caused the headache," Özkan said.

Noting that Akdeniz University is also working on a vaccine, Özkan said that any vaccine study takes a long time since it involves so many safety measures.

"We hope to get one finished soon. I hope Turkish vaccines will enter the worldwide race too," Özkan said.

Turkey's Health Ministry is anticipating a delivery of Chinese COVID-19 vaccines in December, with administration starting on Dec. 11.

Coronavirus: Morocco to kick off mass COVID-19 vaccination plan with Chinese drug

People walk past a bivouac where clinical trials for COVID-19

 vaccines are conducted, in Rabat, Morocco, Dec. 7, 2020.

(AP/Mosa'ab Elshamy)

The Associated Press Tuesday 08 December 2020

Morocco is gearing up for an ambitious COVID-19 vaccination program, aiming to vaccinate 80 percent of its adults in an operation starting this month that’s relying initially on a Chinese vaccine that has not yet completed advanced trials to prove it is safe and effective.

The first injections could come within days, a Health Ministry official told The Associated Press. Facing a public skeptical about the vaccines’ safety and effectiveness, medical experts and health officials have appeared on television in recent weeks to promote the COVID-19 vaccines and encourage Moroccans to get immunized.


While Britain began its vaccination program Tuesday with the Pfizer-BioNTech vaccine and the US and European Union are racing to approve a series of Western-made vaccines, other governments are looking to use vaccines from China and Russia.

For more coronavirus news, visit our dedicated page.

The World Health Organization has said new vaccines should first be tested in tens of thousands of people to prove they work and don’t cause worrisome side effects before being rolled out broadly. But the UN health agency also says it’s is up to individual countries to decide whether there is an urgent domestic need to use a vaccine shot, even without such data.

Morocco is battling a resurgence in virus infections, with the number of recorded deaths from the virus surpassing 6,000. The North African kingdom is pinning its hopes on two vaccine candidates, one developed by China’s Sinopharm and the other by Britain’s Oxford University and AstraZeneca.


A model of a coronavirus is displayed next to boxes for COVID-19 vaccines at an exhibit by Chinese pharmaceutical firm Sinopharm in Beijing, Sept. 5, 2020. (AP/Mark Schiefelbein)

The Sinopharm vaccine has been approved for emergency use in a few countries and the company is still conducting late-stage clinical trials in 10 countries. The AstraZeneca vaccine is still in advanced trials in countries including Britain and the US and hasn’t been approved yet.

Morocco’s government seeks to vaccinate 80 percent of its adults, or 25 million people, as soon as the vaccines are approved by domestic regulators. Priority will go to medical staff and other front-line workers, as well as the elderly.

It will start with the Sinopharm vaccine, which was tested on 600 Moroccans as part of clinical trials this autumn. Morocco has ordered 10 million doses of the vaccine.

Coronavirus: Moroccan medics protest over conditions as COVID-19 surges

The initial deliveries will come from China, but Morocco also plans to produce the vaccine locally, Abdelhakim Yahyan, a senior official at the Ministry of Health, told the state-owned news agency MAP.

Health Minister Khalid Ait Taleb said Morocco is seeking vaccines from several sources because COVID-19 vaccines are such a scarce commodity and a single manufacturer’s production capacity is too limited to meet the needs of the whole world.

In the Moroccan trial of the Sinopharm vaccine, carried out in Casablanca and the capital Rabat from August through November, healthy volunteers received two separate doses of the vaccine. In the advanced trial, volunteers either received the vaccine or a placebo. According to the health minister, early results have proven the vaccine to be “safe and effective” with no severe side effects reported.

However, some Moroccans have taken to social media to question the safety of the vaccine, with some noting that China was the original epicenter of the pandemic or questioning how effective it will be.

A Flourish map

Sinopharm’s shot relies on a tested technology, using a killed virus to deliver the vaccine, similar to how polio immunizations are made. Leading Western competitors, like the vaccine made by Oxford and AstraZeneca, use newer, less-proven technology to target the coronavirus’ spike protein.

In China, the state-owned Sinopharm subsidiary CNBG has given the vaccine to 350,000 people outside its clinical trials, a top CNBG executive has said.

Critics in Morocco have also expressed concerns that citizens might be forced to take the vaccine, but the health minister insisted that COVID-19 vaccinations will not be mandatory but will be free.

Prime Minister Saad-Eddine El Othmani has sought to reassure the vaccine-hesitant about the robustness of the country’s regulatory process for vaccine approval, saying that no corners have been cut in making sure the drug is safe to administer.

Morocco’s mass immunization operation will include 2,888 vaccination stations and the deployment of mobile units to vaccinate people at factories, offices, campuses and prisons. The health ministry said it would mobilize over 12,000 health professionals as well as the military to ensure rapid distribution.

The vaccine will be available in a first phase to those at highest risk of contracting the virus: health professionals, security personnel, essential workers at vital sectors and people suffering from chronic diseases.

No exact date has been set for the rollout, but the health minister said “we are doing our best to get it started in mid-December.”

Separately, Morocco is expected to be among 92 low- and middle-income countries supported by Covax, an international effort to ensure that vaccine supplies reach developing countries, if the group meets its funding targets, according to the World Health Organization.
Last Update: Tuesday, 08 December 2020 KSA 15:45 - GMT 12:45

INDIA

Covid vaccine: Bharat Biotech, Serum Institute have applied for emergency use, confirms Centre

The health ministry also said that some of the vaccines may be licensed in the next few weeks.

Bharat Biotech | Reuters

The Union health ministry on Tuesday confirmed that drug manufacturers Serum Institute of India and Bharat Biotech have applied for emergency use approval of their potential coronavirus vaccines, ANI reported. The development came a day after Serum Institute’s Chief Executive Officer Adar Poonawalla made the announcement on Twitter.

Union Health Ministry Secretary Rajesh Bhushan said that as many as six vaccines were in the clinical stage trials in India and that some of the vaccines may soon get a licence. “Some of the vaccine candidates may get licensed in the next few weeks,” Bhushan said while addressing a press conference on the status of the vaccine programme in the country. “PM [Modi] has interacted with all vaccine manufactures and scientists.”

Bhushan said that India’s regulatory framework has a specific provision for grant of emergency use authorisation, which would be followed in the case of the received applications.

India has not signed a deal for a coronavirus vaccine yet so it is unclear when it will be available for use in the country. However, Prime Minister Narendra Modi had said at an all-party meeting last week that experts believe a coronavirus vaccine could be available in India in the next few weeks.

Serum Institute had had said on November 28 that the Centre was likely to buy 300-400 million [30 to 40 crore] doses of its vaccine by July 2021, even though it did not give anything in writing. On the other hand, Bharat Biotech is currently conducting the phase 3 clinical trials of its vaccine in India, with 26,000 participants from across 22 sites in the country.

India has so far recorded 97,03,770 cases and 1,40,958 deaths. More than 91.78 lakh people have recovered from the disease so far.

Existing Cold Chain Can Store First Lot Of 3 Crore Covid Vaccines: Health Ministry

Maharashtra, Kerala, Karnataka, West Bengal, Delhi contributed 54 per cent of total active coronavirus cases in India.

PTI, 08 December 2020

Representational Image/PTI


Three COVID-19 vaccines, developed by Bharat Biotech, Serum Institute of India and Pfizer, are under active consideration of India's drug regulator and there is hope that early licensure is possible for all or any of them, the Union health ministry said on Tuesday.

Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their COVID-19 vaccines.

At a press briefing, NITI Aayog member (Health) V K Paul said the COVID-19 situation in India has stabilised.

With active cases reducing, a "clear-cut declining trend" in the pandemic is being seen even though the situation in many other countries is becoming quite serious, he said.

The concern and anxiety following an increase in daily cases of infection in Delhi also looks like to have settled, Paul added.

Asked what steps would be followed by the DCGI in the absence of a water-tight emergency use authorisation law for granting licence to vaccine makers, Union Health Secretary Rajesh Bhushan said not all countries' regulatory framework or rules and acts mention emergency use authorisation.

"So, the fact that this phrase is not used in the national regulatory framework of any country does not mean that a specific country would not have an enabling provision to accord an approval which is early and distinct from a regular market approval.

"India's regulatory framework has a specific provision for grant of emergency use authorisation, although this phrase is not used," he said.

The New Drugs and Clinical Trials Rules, 2019, clearly specifies that under specific special situations, relaxation, abbreviation, omission, or deferment of data including local clinical trial data may be considered for approval.

"This is our law. Similarly, other countries too have their laws," Bhushan said.

Giving a bird's-eye view of the Indian landscape of Covid-19 vaccines, Bhushan mentioned that eight vaccines are at different stages of development.

One is Covishield, manufactured by Serum Institute of India in collaboration with AstraZeneca. Phase two and three clinical trials of this vaccine is underway and the firm has applied for emergency use authorisation.

Another is Covaxin, which is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and is in phase three of clinical trials. It has also applied for emergency use authorisation.

The third one is ZyCOV-D, being developed by Cadila Healthcare Ltd in Ahmedabad in collaboration with the Centre's Department of Biotechnology and is in phase two of the trials.

The fourth vaccine candidate is Sputnik V which is being manufactured by Dr Reddy's Lab, Hyderabad, in collaboration with Russia's Gamaleya National Centre. The phase two trial in India is over and phase three will begin next week.

The fifth one is NVX-CoV2373, which is being developed by Serum Institute of India in collaboration with Novavax and its phase three clinical trial is under consideration with the drug regulator.

The sixth vaccine candidate is Recombinant Protein Antigen-based vaccine, to be manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA.

Its pre-clinical animal studies have concluded and phase one and two human clinical trials have started. Another one is HGCO 19, being manufactured by Genova in Pune in collaboration with HDT, USA. Its pre-clinical animal studies are over and phase one and two clinical trials is set to start.

The eighth vaccine is being developed by Bharat Biotech International Ltd in collaboration with Thomas Jefferson University, USA and it is at the pre-clinical stages.

"Another vaccine, which is in the initial stage, is being developed by Aurbindo Pharma. So, there are nine vaccines out of which six are in clinical trials and three are in pre-clinical stage," Bhushan said.

"There are multiple vaccine candidates in different stages of development and some may get licensed in the next few weeks. But we cannot foretell at this moment because licensure or market authorization is the domain of the national regulator."

Most of the vaccines are of two or three doses to be administered three to four weeks apart. However, even after vaccination, COVID precautions must be taken and this has been advised by WHO also, Bhushan said, adding, "Vaccination does not mean people become carefree."

About cold chain infrastructure augmentation, the health secretary said presently the system consists of 85,634 equipment for storage of vaccine at about 28,947 cold chain points across the country

"Current cold chain is capable of storing additional quantity of Covid-19 vaccine required for first the three crore -- healthcare and frontline workers," he said, adding states have collected data of frontline healthcare workers who would get the shots.

The data is being uploaded on Co-WIN software, Bhushan said.

The ministry, in consultation with states, has assessed the additional requirement for cold chain storage and the first supply of such additional equipment would begin from December 10, the health secretary said.

Bhushan said that while 2.38 lakh auxiliary nurse midwives help in vaccination under universal immunisation programme, only 1.54 lakh such health workers will be used for Covid-19 inoculation.

Additional vaccinators are being arranged in collaboration with states and UTs, he added.

 

New study shows longer time at home increases binge drinking

Reviewed by Emily Henderson, B.Sc.Dec 7 2020

Harmful drinking among adults increases the longer they spend at home in lockdown, according to a study published in the peer-reviewed American Journal of Drug and Alcohol Abuse.

The research, based on a survey of nearly 2,000 over-18s in the US, is the first to highlight the relationship nationally between hazardous drinking and life stresses triggered by the COVID-19 pandemic and the associated 'lockdowns'.

The findings show the odds of heavy alcohol consumption among binge drinkers - those who, within two hours, consumed five or more drinks for men and four and above for women - rose an extra 19% for every week of lockdown. The odds of increased alcohol intake overall for binge drinkers was more than double that of people who did not drink excessively (60% vs 28%), especially those with depression or a history of the disease.

Carried out by experts at the University of Texas Health Science Center School of Public Health, in Dallas, the study also highlights that:

• During the pandemic, binge drinkers on average drank four drinks per occasion, compared to two drinks among non-binge drinkers.
• Participants who drank at harmful levels during the pandemic would consume seven drinks maximum on one occasion. This is compared to a maximum of two per session during the pandemic for those who did not.
• Living with children in lockdown minimally reduced the odds (by 26%) of turning to the bottle for people in general.

The researchers are now calling for new intervention and prevention strategies for people in isolation at risk of hazardous drinking. Otherwise, they say there could be long-lasting health consequences.

Increased time spent at home is a life stressor that impacts drinking and the Covid-19 pandemic may have exacerbated this stress."

Sitara Weerakoon, PhD candidate, University of Texas

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"Future research should consider the potential for depressive symptoms acting as a moderator (a factor that changes the impact) in the relation between the time spent under a shelter-in-place mandate (lockdown) and binge drinking. "Additional research is (also) needed to develop best treatment for people with substance use disorders who may be more susceptible to adverse health outcomes."

The study aim was to identify a link between COVID-19-related stress factors and changes in alcohol consumption and binge drinking since the pandemic began.

The data was from an online survey completed by 1,982 adults from mid-March to mid-April, which coincided with the first US state-wide stay-at-home order on March 19. The average age of participants was 42 and the majority were white (89%) and female (69%).

Based on survey responses, the researchers categorized participants as binge drinkers, non-binge drinkers and non-drinkers. Among the factors analyzed were length of time spent in lockdown, how many adults or children they were living with, current or previous episodes of depression, and job status related to lockdown such as decreased pay.

On average, every respondent had been in lockdown for four weeks, and spent 21 hours a day at home, with the majority (72%) not leaving for work. Overall, nearly a third (32%) of participants reported binge drinking during the pandemic with binge drinkers increasing their intake. However, non-binge drinkers consumed about the same amount of alcohol than before lockdown.

Limitations of the study include the survey data being self-reported, and the fact the question on binge-drinking did not specify a time within which the alcohol was consumed. In addition, the majority (70%) of participants were relatively high earners, a factor already associated with hazardous alcohol use. The authors say future research is needed in a more 'generalizable population'.

Source:

Taylor & Francis Group

Journal reference:

Weerakoon, S.M., et al. (2020) Longer time spent at home during COVID-19 pandemic is associated with binge drinking among US adults. The American Journal of Drug and Alcohol Abuse. doi.org/10.1080/00952990.2020.1832508.