Corona Daily 238: The Costliest 8 seconds

A New York Times article from this week throws light on the type of punishments served for flouting coronavirus regulations.

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In May, Prince Jochim of Belgium, 28, landed in Spain.  Perhaps he assumed the 14-day quarantine was not for the royals. He took a flight from Madrid to Cordoba to meet his girlfriend. The couple attended a party with 27 people. After that he tested positive.

The Belgian Prince was fined 10,400 Euros ($12,600). As expected, he deeply regretted his actions. Spain has fined more than a million people for breach of quarantine.

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Last month, an unnamed 48-year-old Italian had an argument with his wife and left home to “clear his head”. He is from Como, in the north of Italy. A week later, he was found in the coastal town of Fano, 280 miles away from his home. His wife had reported him missing to the police. He had apparently walked 40 miles every day, with strangers feeding him on the way. He was called the Italian “Forest Gump” on social media. His wife was allowed to drive and pick him up. She had to pay 400 Euros ($485) before taking custody of the husband, who was charged for breaking the curfew rules.

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Taiwan places arriving workers in quarantine hotels. A migrant worker from the Philippines was asked to spend 14 days inside a hotel room in Kaoshing, the south of Taiwan. He wanted to give something to his friend quarantined next door. The video shows the man in shorts and flip-flops leaving his room for 8 seconds. He takes just six strides and returns to his room. When CCTV caught those 8 seconds, he was charged $3,550, each second costing him more than $400.

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Australia doesn’t shy away from naming men. Noel Atkinson, 48, is a construction worker. His mother was born in India. Craving Indian curry one night, he drove 20 miles to reach an Indian restaurant for butter chicken. He was fined $1,230 for breach of lockdown.

Mr Atkinson, an essential worker, drives 50 miles to work every day. Why was he fined for driving 20 miles? You are allowed to drive for work, not for takeaways, he was told.

The owner of Desi Dhaba, the curry place, has taken pity on the fined man. He has offered Mr Atkinson free butter chicken for his orders next year (presumably after the restrictions are lifted).

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Mr Atkinson was the lucky one, he got away with a fine. Yusuf Karakaya, 31, used a ladder to sneak in and out of his quarantine hotel to see his girlfriend. He was given a six-month jail term. The magistrate said a jail term was needed to send a strong message to the community.

Asher Vander Snaden, instead of staying in her quarantine hotel in Western Australia, left the state by hiding in a car transported in a truck. She was also given a six-month jail sentence.  

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This month, in India, the Gujarat high court was creative in punishing people wearing no masks. The court stipulated that the culprits should be given non-medical community service duty in “Covid Care Centres”. This will make the violators better understand the nature of the virus. To have the desired deterrent effect, those cases should get wide publicity in the media, the court suggested.

India’s Supreme Court, however, has stayed the high court order calling the sentence too harsh.

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In countries with strict regulations, people must understand that it is nearly impossible to break the law without being caught by the omnipresent CCTVs.

Taiwan’s suppression performance is brilliant. It has had just 736 cases, and 7 deaths, the last death on 11 May. Australia is a democracy, but can ruthlessly send people to jail for flouting regulations. Australia is almost free from the virus. Countries like the USA may have something to learn here.  

Ravi 

Corona Daily 239: Sputnik-Oxford - a Bizarre Strategy

Yesterday, British and Russian vaccine makers announced their plan to create a joint vaccine. In a few months, the world may see the sovereign Boris Johnson and the eternal Vladimir Putin triumphantly presenting the Sputnik-Oxford vaccine on TV.

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The Oxford/Astra Zeneca vaccine was leading in the vaccine race for most of the year. It was cheap, traditional, easy to transport and store (at 2c-8c). Britain ordered 100 million doses, 30 million to be delivered by September. India’s Serum institute has gambled and produced millions of doses without any approval. In May, USA’s Operation Warp Speed made its biggest investment. Though AstraZeneca had little experience in vaccines, USA poured $1.2 billion for development and production in exchange for 300 million doses. AstraZeneca’s stock skyrocketed.

The Oxford/AZ vaccine was expected to have 60% worldwide share among the Covid-19 vaccines.

Things went downhill there onwards. A British participant developed neurological symptoms in July. The trial was paused, but FDA not informed. The US trial was halted for 47 days, restarted only by end October. Earlier, I have explained AstraZeneca’s errors and attempts to cover-up things. The Lancet article published last week added another twist. Some participants received the second dose after three months, instead of one month as planned. This shows a high level of carelessness in clinical trials.

What is the solution found by the British company? To join hands with the Russian vaccine maker.

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With Pfizer and Moderna reporting efficacy above 90%, there is pressure on other vaccine makers to produce higher numbers. Oxford/AZ in the best-case scenario is 70% effective. Russia’s Sputnik-V is reportedly 95% effective, though the reports are not backed by any data.

Now, Oxford-AZ wants to mix and match those two vaccines. This concept is known as a heterologous (rather than homologous) boost. A person will receive the Oxford shot first and after a month the Sputnik shot (or the other way round). Oxford uses a Chimpanzee adenovirus, whereas Sputnik uses a human adenovirus. Such diversity, it is hoped, will produce a greater and longer immune response.

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In business, the product itself is only part of the consumer attraction. The price, reputation, advertising and other factors influence demand. The Pfizer vaccine, though possibly an excellent product, suffers from logistical problems. Trust in the vaccine is an important factor. What’s the use of a superlative product, if people don’t trust it?

Russia and Soviet Union before that are not famous for product quality. (Soviet microprocessors were the largest in the world, Zenit cameras the heaviest and watches the fastest). I have already written about the Gamaleya Institute not being able to produce a single effective vaccine.

In one of the great geopolitical puzzles, India has been buying Russia’s Mig fighter aircraft for the past forty years. They fall more than they fly. Every few months, a Mig crashes killing young Indian pilots. (Today, Navy commander Nishant Singh was cremated. He died in a Mig-29K crash). India doesn’t need enemies or wars, simply buying Migs does the job. On the other hand, Russia’s deadliest nerve agent, Novichok, fails to kill the targets. (Instead of using Novichok on them, former Russian spies or opposition leaders can simply be flown in a Mig-29.)

With products impacting life-and-death, the reputation of Russian brands is suspect. Vaccines are one of those products.

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That is the reason I find the British company’s strategy bizarre. It is like trying to combine two average minds to create a genius. Oxford/AstraZeneca appears to be confused and desperate. Their vaccine was meant to be the savior of the poor world, the most widely used covid vaccine in Asia and Africa. Sputnik-V has not reported scientific data and is not approved outside Russia. New large trials will need to be run that will take months. In covid times, vaccine manufacturers must keep things simple. Joining hands with Sputnik may discourage regulators to approve it. Many countries may prefer Chinese vaccines. China’s product quality reputation is not as bad as Russia’s.

Ravi 

Corona Daily 240: 15 Minute Observation Rule

An astounding scientific breakthrough can be marred by poor understanding of logistics. The scientist couple who invented the novel technology used in Pfizer vaccines specializes in cancer research. Technology requiring -70C is tolerable for a niche population of cancer patients, but not for national and international rollout. UK is beginning to understand the logistical challenge with several family doctors/ General practitioners now withdrawing from the vaccination rollout.

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To cover its population of 68 million with two doses, UK must deliver 2 million shots every week, which is 400 jabs every minute. Even such a brilliant performance will vaccinate the nation only by the second quarter of 2022.

Vaccination began in 50 hospital hubs this week. Next week, GPs at 280 sites were expected to administer 273,000 doses. But several GPs in Sussex, Lincolnshire, Yorkshire, Thames valley and other places have pulled out. The problem is especially acute in Manchester.

NHS has negotiated a contract with the doctors’ trade union that obliges a GP who signs it to vaccinate 8 am to 8 pm all 7 days, all holidays, for nine months. NHS also has a contractual right to impose new conditions unilaterally.

Because of the freak conditions imposed by the cold chain, each GP site must deliver 975 doses in 3.5 days (or else the vaccine gets spoilt). Rather than pre-filled syringes, the vaccines are stored in boxes of 195 vials containing five doses each, which means they need to be diluted and split into individual jabs.

As if this was not enough, yesterday MHRA confirmed a 15-minute observation rule. This was prompted by the two allergy cases. To rule out anaphylaxis, the vaccinee must wait for a minimum of fifteen minutes under observation.

GP practices have heavy workloads and fewer staff. They know the importance of vaccination, but with their conversion into vaccine centres, they won’t be able to attend to patients. They are at a loss about what to do with the 15-minute wait. The waiting rooms and the car parks will be full, and the process will be slow.  

In an average year, GPs administer 15 million flu shots. But flu shots don’t require 70C storage, two doses, social distancing, and fifteen-minute observation. The second dose after precisely 21 days is another challenge. UK hasn’t rolled out IT systems to individual GPs or pharmacies. They are required to operate their own systems or carry out the process manually. The army has been asked to help, but it has no electronic patient records nor IT access. The GP switchboards are jammed, with people calling the whole day asking when they can get the vaccines.

Many GP practices must hire extra staff, install special super-freezers and reconfigure surgeries to manage the patient flow, at the same time observing social distancing.

There is little compensation for such hardship and loss of regular practice. The NHS and the GPs know the disastrous rollouts of testing and tracing services.  

Oxford/AstraZeneca vaccine is expected to have normal (2c-8c) cold chain conditions. Many GPs would rather wait for that vaccine to get approved, rather than bother about the Pfizer vaccine.

Already more than 100,000 residents must look for alternatives, as a result of their GPs withdrawing.

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The cold chain conditions mean people must go to vaccines, rather than vaccines coming to them. Vaccinations of those in the care homes has been postponed.

NHS doctors, nurses and other frontline staff were supposed to be the first to be vaccinated. In the first week of December, for unknown reasons, it was decided to vaccinate senior citizens (80+) instead. This is like denying a restaurant chef the food he prepares for others. That decision should be reversed. Hospitals with freezers are the best places for vaccinations. Rather than making a mess with GPs and pharmacies, UK should focus on using the Pfizer vaccines for the NHS staff first. If lucky, a logistically normal vaccine may arrive in time for the rollout.

Ravi 

Corona Daily 241: Two Yellow Cards – UK’s Allergy Warning

UK has a wonderful “Yellow Card Scheme” since 1964, where any adverse reaction to a drug or vaccine can be immediately reported. Earlier done through actual yellow cards, now it is online. Yesterday, two Pfizer vaccinated NHS workers reported an anaphylactoid reaction, which may cause a skin rash, breathlessness and a drop in blood pressure. Both vaccinees had a history of allergies. UK has now advised people prone to severe allergies to avoid the vaccine. The advice also requires vaccine facilities to have resuscitation measures available.

This has caused concern in the minds of those planning to get the vaccine, and a sadistic joy to the anti-vaccine crowd. This analysis will show why the concern is unfounded.

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Most drugs and vaccines have side effects. The decision for any medical intervention is based on the risk-benefit analysis. Chemotherapy drugs that cause exhaustion, hair loss, anemia, infertility, sleep problems are an extreme example. This known debilitating impact is weighed against possible survival from a terminal cancer.

Vaccines prevent, rather than cure, diseases. Here we must weigh the risk of contracting Covid and dying from it versus the vaccine risks. In the last eight months, nearly one person out of 1000 has died of covid in the USA, UK, Italy or Spain. (In India, one out of 10,000). If you belong to a covid vulnerable group, the probability of death is much higher.  

Against that, the 95% effective Pfizer vaccine reports injection site reactions (84%), fatigue (63%), headache (55%), muscle pain (38%), chills (32%), joint pain (24%) and fever (14%).

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To help your decision on the Pfizer vaccine (in case you can get it), I offer two documents that discuss your eligibility.

The first is the Pfizer protocol where they clearly state who is excluded from the trials. (Pages 37-40). The second is a fresh document. It will be used later today in the FDA meeting to discuss the Pfizer vaccine approval in the USA. (Pages 48-49).

Pfizer protocol clearly excludes: “Those with history of severe allergic reaction (e.g., anaphylaxis).

Without any medical knowledge, it is common sense that categories excluded in the vaccine trials must be excluded from vaccination. The UK regulatory authorities botched this up. The two NHS workers were not eligible (they carried adrenaline pens on them, meaning they were known severe allergic cases). Before vaccinating, it is the duty of the health authorities to ensure the person qualifies for the shot.

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Who else is not eligible?

Mainly anyone below 16 years of age, pregnant or breastfeeding women and immunocompromised people. AIDS patients, for example, have their immunity compromised. In case of doubt, make sure with your doctor you are immunocompetent rather than compromised. The protocol excluded some more: those with a psychiatric condition, suicidal behaviour, prone to prolonged bleeding. Pregnancy is such a sensitive issue that participants needed to promise not to get pregnant, by following highly effective contraception consistently and correctly.

Pfizer hasn’t revealed its vaccine recipe. But we know many flu vaccines contain egg proteins. Those severely allergic to eggs are advised not to take a flu vaccine.

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I will give you two more bits of news from the Pfizer report. Six participants died since the start of the trial, two from the vaccine group and four from the placebo group. This is not a concern, because in very large trials some people are going to die as a matter of natural course. If the UK is giving vaccines to people over 90, some may die in a matter of weeks after receiving a vaccine. Let that news not bother you.

Pfizer also found that four vaccinated participants developed Bell’s Palsy, a temporary facial paralysis. This again can be a chance event. Surprisingly, between April and July, Mumbai and Bangalore reported many cases where Covid-19 had caused Bell’s Palsy.

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In short, if you are older than 16, not pregnant now or in near future, your immunity is not compromised, you don’t suffer from a serious allergy, you can go ahead and get vaccinated.  The risk is worth taking.

Ravi 

Corona Daily 242: Can We Be Forced to Get a Covid Vaccine?

Can democratic nations make covid vaccinations mandatory? Does such a mandate clash with the concept of individual liberty? Are we the sole judge of what can be done with our bodies or can the state legislate to stick a needle in them?

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So far, only the governor of Sao Paulo has announced he will vaccinate all 45 million residents through a legal mandate. Brazil’s president Bolsonaro, a Trump twin, is against. But Bolsonaro forgets that in February Brazil passed emergency legislation that allows mandatory vaccination. The Sao Paulo governor doesn’t yet have the vaccine, but the Chinese coronavac is a top contender.

In 1904, Rio de Janeiro was in the grip of a smallpox epidemic. Sanitary workers accompanied by the police were authorized to enter people’s homes to vaccinate them. People rioted, with a few dozens killed. This was known as the Vaccine Revolt.

A couple of years before that, Massachusetts had adopted a law to make smallpox vaccination obligatory. Failure attracted cash fines. The courts upheld the mandate by dismissing the challenges.

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Democratic nations currently may have compulsory vaccination in three areas. (a) School going children (b) military and (c) healthcare workers.

American laws require vaccination for students. In France, parents can be punished if children miss vaccinations. India relies on ancient British laws, and certain state laws. Where acceptance is widespread, vaccines appear to be voluntary.

US military troops must be immunized against tetanus, diphtheria, hepatitis A, polio and other diseases. Hospital doctors and staff may be required vaccination against pertussis, chickenpox, measles, mumps and rubella.

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Let’s talk specifically about the Covid-19 vaccines.

First, until FDA and other regulatory bodies issue a full licence, a vaccine can’t be made mandatory by the State. Vaccines given an EUA (Emergency Use Authorisation) are considered investigational. Their long-term impact is not known. It may take a few years before any Covid vaccine gets a full licence. In the past, Anthrax (2005) vaccine has been the only one where the FDA had issued an EUA.

Secondly, unless vaccines are widely available, they can’t be made compulsory. Again, until 2022, it is not certain the vaccine supply will be able to meet the population size.

Thirdly, children and pregnant women have not been included in any trials. An EUA can’t allow untried sections of the populations to be vaccinated.

Fourth, the cost of the vaccines. Unless they are supplied free of cost or very cheaply, a government doesn’t have the moral ground to make the covid vaccine mandatory.

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There are ways, though, to make vaccines mandatory without passing laws. Qantas, the Australian airline which calls itself the safest airline, has announced vaccines will be mandatory to fly Qantas. This is not fantasy. Today, to board an Emirates flight to Dubai, all passengers must present a negative Covid-19 test certificate. When my family went to Kenya on vacation, all of us had to queue up to take a yellow fever vaccine, with a document to prove it.

Employers have the right to make vaccines mandatory for employees. To be fair, in such a case the employer should sponsor the vaccines. In 2001, when I worked in Poland, my employer had arranged a drive in the office for an influenza vaccine. People generally don’t resist vaccine mandates by those who give them monthly paychecks.

Depending on the length of the pandemic, and vaccine availability; sports stadiums, music concerts, cinemas, restaurants can all require a “COVID-19 vaccine certificate” for entry. The Indian biometric ID, Aadhar, issued to 1.3 billion Indians, is legally not mandatory. But without it, Indians can’t open bank accounts, buy sim cards, execute agreements, buy or sell apartments.

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I hope by 2022, the world will be reasonably free of the coronavirus. I don’t really fancy the idea of carrying a vaccine certificate to attend a music concert.

Ravi 

Corona Daily 243: Dummy Parachutes

At 06.45 UK time this morning, 90-year-old Margaret Keenan became the first person in the West to receive a covid vaccine. The UK government has decided to prioritise 80+ year old patients in the hospitals. Just by way of trivia, the second recipient was an 81-year-old male named William Shakespeare. This is not English humour.

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Last week, Moderna published the interim results of its trials. Out of the 196 corona positive cases, 185 were in the placebo group, only 11 in the vaccine group. (Which makes the vaccine 94.1% effective). All thirty severe cases were in the placebo group. None in the vaccine group. There was one covid-death among the volunteers. It occurred in the placebo group.

As you know, half of the participants are delivered a real vaccine, the other half a placebo. The double-blinded trials don’t let the participants or the medical staff know who has got what.

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Placebo is a major ethical issue in medical science. Though administered with the volunteer’s informed consent, it is essentially deception. When no drug or vaccine exists, such altruism is justifiable in the name of the greater good. What happens when an effective vaccine exists?

It’s almost certain the Moderna volunteer would have been alive today had he received a vaccine instead of a placebo. But neither Pfizer nor Moderna had published their results when he/she died. So, that can be attributed to bad luck. The trials will continue for the next two years to assess long-term effects. Not only that, more than 75 different vaccines are conducting trials, injecting thousands of volunteers with salt water or some other dummy shot. Like the Moderna participant, some placebo recipients may die in the future.

This has posed a huge dilemma, currently being debated in the scientific world.

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The position of ethicists is clear. Once a successful vaccine exists, it is unethical to give a placebo to anyone. The placebo recipients should be unblinded, vaccine shots given to protect them. This is a reward for the risk they took. No participants in future trials can be given a placebo, once an effective Pfizer, or Moderna or some other vaccine exists.

Which, in effect, means all trials worldwide should be halted with immediate effect.

Moncef Slaoui, the chief advisor to Operation Warp Speed, in fact, said the trial participants (meaning placebo group) should be the first in line to be vaccinated. Pfizer had 44,000 and Moderna 30,000 participants in the USA, collectively 37,000 placebo recipients. Ethically speaking, they should be the first 37,000 people (74,000 doses) vaccinated. But with vaccine scarcity, this is not mentioned in any of the US plans.

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Two professors from the University of Lethbridge are opposed to the concept of placebo. They offer an analogy with parachutes. If during wartime, a new type of parachute is urgently needed, sooner or later it must be tried in a real jump. We won’t let that happen until we are quite sure of its safety. And certainly, we will not give dummy parachutes to a randomly selected control group of volunteers.

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The World Health Organisation deliberated over this dilemma and issued a verdict: While vaccine supplies are limited, and the vaccines are investigational, WHO considers it ethically appropriate to continue the blinded follow-up of placebo recipients as well as new recruitment for vaccine/placebo trials. Trial sponsors are not obliged to reveal to any volunteers if they received a vaccine or a placebo.

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WHO was alarmed at the prospect of stopping trials. The long-term effects of the vaccine are unknown, so running them for another two years is essential, even if that means a few deaths among the placebo recipients.

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I will make an unscientific suggestion to continue the trials. The trial sponsor can invite anti-vaccine volunteers and give them a placebo. Give the vaccine to those who believe in a vaccine. In that case, if the placebo recipient dies of covid, there is no ground for complaint or regret.

Ravi 

Corona Daily 244: The Tuskegee Experiment

Barack Obama, George Bush, Bill Clinton and Joe Biden have offered to get vaccinated on live TV to inspire confidence in the COVID-19 vaccines. This is not new. In 1956, the Salk vaccine against polio had just been invented. Teenagers, vulnerable to the crippling disease, were reluctant or indifferent to getting a shot. To solve that problem, Elvis Presley took a Salk Polio vaccine jab on a popular TV show.

Last year, WHO listed ten major global health threats. They included climate change, cancer, HIV, a pandemic; also, “vaccine hesitancy” – distrust towards vaccines. Drugs are usually given to the ill, vaccines administered to healthy people. That makes the reluctance stronger. Scientific data suggests two to three million deaths are prevented every year due to vaccinations. If all people were to trust in vaccines, annually another 1.5 million deaths could have been prevented. Smallpox has been eradicated, and polio nearly extinct.

Usually, certain historical reasons exist for strong anti-vax feelings.

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In the Covid-19 pandemic, in the USA, a disproportionately large numbers of Blacks are infected, hospitalized and dead. As compared to Whites; Blacks (and Latinos) are hospitalized four times more, and dying three times more. Among the younger age groups, the difference is wider. It’s possible many African Americans work in front line and essential jobs, exposing themselves more. They have high rates of diabetes, hypertension and obesity. It is obvious the vaccines are necessary and will be more useful for the black community. And yet, for the vaccine trials across USA, only 3% of the people who signed up were black.

“I won’t be used as a guinea pig for white people.” One black man declared.

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In 1932, in the state of Alabama, the US Public Health Service started an experiment called TSUS (the Tuskegee Study of Untreated Syphilis in the Negro Male). From the Tuskegee community, 600 poor black men were chosen. 399 of them had the sexually transmitted disease - syphilis. The control group had 201 men who were not infected. They were told the experiment would last for six months. In reality, it lasted for forty years, until 1972.

Those who ran the experiment, white men, wanted to see what course nature takes if the syphilis patients are not given any treatment. The black men were promised free medical care, but were never told about the diagnosis, nor the risk of infecting others, nor the fact that the disease could affect a variety of organs and lead to death. Participants were subjected to blood draws; spine taps and finally autopsies. They were told they were being treated for “bad blood”. Penicillin was available from 1947, and could have cured many of the infected men. The participants were never told about penicillin.

By 1972, only 74 subjects were still alive. Of the original 399 men, 28 had died of syphilis, 100 of related complications, 40 of their wives were infected, and 19 of their children were born with congenital syphilis.

The unethical and deadly forty-year experiment was one of the most appalling examples of medical exploitation.

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The other example is more recent. In 2011, to locate Osama Bin Laden in Pakistan, the CIA ran a fake vaccination clinic. A Pakistani doctor announced a free hepatitis B vaccination campaign in Abbottabad. The real purpose was to see if a DNA sample could be obtained from anybody from Bin Laden’s family. The doctor is now serving a 33-year prison sentence.

Worse, the distrust in vaccinations grew. Islamist preachers and militant groups in Pakistan and Taliban suspect vaccination is a plot to kill or sterilize Muslims. Vaccinators are attacked and sometimes killed.

This is the key reason why polio now exists in only two countries – Pakistan and Afghanistan.

Ravi 

Corona Daily 245: The Sputnik-V Story

Yesterday, Russians finally received a dose of good news. Just like Russia had won the vaccine race, it became the first nation to start vaccinating its citizens. Russia’s daily cases (25000+) and daily deaths (500+) are setting new records every day. These are official, rather than actual, figures. In the spring itself, the federal government had directed local authorities to classify deaths as resulting from heart disease, HIV, or other conditions that may have been made worse by coronavirus, rather than list covid-19 as the cause of death.

Sputnik-V is a great brand name reminding the old generation of Russia’s superpower status in the 1950s. The vaccine has been pronounced as 95% effective, based on 20 cases. The data hasn’t been published or shared. The phase III trials continue. They will end in May or June 2021. But vaccination began in Moscow yesterday.

Dmitry Kisilyov, the TV anchor (Russia’s Sean Hannity or Arnab Goswami) said: “Sputnik-V is like a Kalashnikov, simple and reliable.” I would say this is a rather unfortunate comparison given the outcome of using a Kalashnikov.

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Russia wishes to compete with China on vaccine diplomacy. It says it has orders for 1.2 billion doses from 50 countries. Sputnik-V is free for Russians. Foreigners will pay less than $20 for two doses. Cheaper than the Western vaccines.

In July, Russia announced it will produce 200 million doses by December 2020. In September, this was reduced to 10 mn. And the latest estimate is 2 million.

There is a further complication. The two doses need to be given with a gap of 21 days. It seems the two adenovirus doses have different compositions – the first based on serotype 26, second on serotype 5. Technical problems have developed in producing the second dose. But few Russians were injected with the first dose yesterday. It is hoped the production problems with the second dose will be resolved before the second dose is due. Now the authorities have said 21 days doesn’t really mean 21 days – it can be anywhere between 21 days and 50 days. (Meaning they think the problem may take up to fifty days to resolve).

Tatyana Golikova, the deputy Prime Minister, delivered another shock in her announcement. There is a long list of those who are not eligible to get the vaccine – people with a heart condition, tuberculosis, hepatitis, syphilis etc. In the west, elderly are the priority. In Russia, eligibility is restricted to between 18 and 60 years of age.  Golikova said it would take 42 days after vaccination to develop immunity. During those 42 days, the vaccinated person must wear a mask, avoid crowds – and not drink alcohol. This instantly made the entire Russian male population join the anti-vaxx movement. Forty-two days sobriety is an inhuman requirement.

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Sputnik-V needs a constant minus 18 C temperature. Unless vaccination is exclusively carried out in the Siberian winter, this requires special freezers. The plans for transport or storage are not clear. The problem is solved for the moment because the production for the foreseeable future will be so low, it can be entirely used in Moscow, where freezers are available.

In Soviet times, the drugs and vaccine production happened in the Baltic republics and Hungary. Russia has not registered a single drug or vaccine in the EU or USA. It has some experience of developing, but not production. Some of the production lines are from Soviet times, manufactured in a country that no longer exists. Production for trials is not the same thing as production for mass vaccination. Russia could outsource production to India, as they plan to, but Indian companies will not touch the Russian vaccines until they fulfill the American and European orders.

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This narration should make the Russians happy. It shows there is little possibility of having to abstain from drinking for forty-two days.

Ravi 

Corona Daily 246: China’s Efficient Vaccine Approval Process

The media is currently buzzing with talk of approvals for Pfizer, Moderna and AstraZeneca vaccines. But much before that, in July, “Coronavac”, a vaccine by the Chinese company “Sinovac Biotech” was approved for limited use in China.

Beijing based Sinovac was the first company to conduct SARS vaccine clinical trials (2003). it was also the first to develop a swine flu vaccine (2009). Yin Weidong (in picture), 56, its founder and chairman, started his career in the early 1980s at a public health unit. On his first day, he was assigned to a group investigating hepatitis outbreaks. After spending two decades in working on preventing liver disease in rural China, he founded Sinovac in 2001. Sinovac prefers the traditional method of using an inactivated virus. Not fancy like the Pfizer vaccine, it can be mass produced, easily stored and distributed. In September 2020, Yin Weidong stated his ambition of applying to the US FDA for approval, and supplying coronavac around the world, including the USA and Europe.

Will he succeed in that ambition?

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To answer this question, two written judgments issued by Beijing’s no.1 Intermediate People’s Court may help. The criminal case judgments are called “Hongzhang Yin’s Acceptance of Bribes” and “Guo’s Acceptance of Bribes”. Yin Hongzhang was in charge of approving drugs and vaccines. Guo is his wife.

That story begins in 2002, a year after the founding of Sinovac. Yin Hongzhang told Yin Weidong he wanted a car. Sinovac made a $15,200 cash gift to enable him buy a car. A few months later, Healive hepatitis A vaccine, Sinovac’s first flagship product, was approved for sale.

In 2006, Hongzhang’s wife Guo wished to furnish their new apartment. Yin Weidong gifted $7600 to sponsor the furnishing. When Weidong visited the furnished house, he gave the couple another $15,200 in cash for housewarming. During that period, Sinovac gained approvals to sell influenza, avian flu and swine flu vaccines in China. Swine flu vaccine was the fastest, launched six months after the virus was first detected in Mexico.

In 2011, Yin Hongzhang asked Yin Weidong for a “loan” of $45,600 to buy a villa in Beijing’s northern outskirts. This time Weidong used a middleman who handed over the cash to the couple in a hotel lobby. Guo admitted the thought of returning the loan never occurred to them.

Yin Hongzhang was sentenced to 10 years in prison and fined 500,000 yuan ($72,000). His wife and son were also sent to prison. Hongzhang admitted to receiving cash bribes as well as ivory products to speed up vaccine approvals.

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Yin Hongzhang was fortunate. Earlier in 2007, China had executed Zheng Xiaoyu, the Head of China’s Food and Drug Administration. During Zheng’s tenure from 1998 to 2005, he had approved six drugs that turned out to be fake. One approved antibiotic was contaminated and killed at least ten people.

It is possible the Sinovac vaccines are good, thereby sparing Hongzhang a death sentence.

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Yin Weidong, the head of Sinovac who had bribed his way to speed up the vaccine approvals was not charged by the courts. “How could I refuse demands for money from a regulatory official?” he said in his testimony. The impeccable logic of the question and his cooperation in divulging the precise amounts and dates of bribing meant he was adjudged an innocent man. He continues to head Sinovac.

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In a boardroom scandal, minority shareholders of Sinovac tried a coup to overthrow Yin Weidong. The coup was unsuccessful. However, following that attempt, Nasdaq, the US stock exchange, has frozen Sinovac shares since February 2019. Even if Sinovac were to become a roaring success, the price of its frozen shares will not alter.

Coronavac has been actively marketed in poor countries. When there are no options and a pandemic is raging, you take what you get. In any case, Sinovac is unlikely to face hurdles in getting speedy approvals.

Ravi 

Corona Daily 247: Hackers - Vaccines, Hospitals, now the Cold Chain

Yesterday, IBM’s cybersecurity issued details about a sophisticated, coordinated hacking campaign to penetrate the vital “cold chain” for the vaccines. The attackers were working to get access to how the vaccine is shipped, stored, refrigerated, and distributed.

In September, I had reported about Chinese and Russian hackers trying to steal vaccine technology. In October, hackers attacked American hospitals asking for ransom in many cases. Now the latest discovery finds hackers interested in the cold chain.

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Haier Biomedical, a Chinese company, is perhaps the world’s only complete chain provider. The hacker impersonated a business executive from Haier, and sent phishing emails to organisations connected with the covid-19 cold chain. The email said “we want to place an order with your company”, and included a draft contract. Haier biomedical is a reputed and legitimate company in this business, so most recipients believed the emails. The draft contract contained malware that would give the hackers access to the network.

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This is a well-planned attack with targets chosen systematically and thoroughly. They included the European customs, something that can impact 27 countries. Energy companies providing solar panels were targeted. The solar panels would provide power for the cold chain in places where electric supply is not reliable. The hacking attack was launched in six countries. Along with vaccine manufacturers; website, software and internet security solution sectors; UNICEF which is planning delivery of vaccines to poorer countries were also targeted. The vaccine alliance’s CCEOP (Cold Chain Equipment Optimisation Platform) was a targete. The scale and coordination make security experts believe there is some State behind these attacks. The same experts rule out China, because it is unlikely the Chinese hackers would impersonate a Chinese company.

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What could be the reasons for the hacking?

It could be stealing of useful information – theft of intellectual property. Criminals may want to illegally obtain a hot black-market commodity; vaccines are likely to be scarce for at least six months. Ransom is a popular motive. The hackers can lock up the distribution network, or the energy supply, and ask for huge money to unlock it.

Or it could be pure evil – disruption and sabotage. A similar motive as of those who fly airplanes into tall towers.

Considering the threat, FBI officials also issued a warning yesterday.

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American media mentions North Korea and Russia as probable suspects, without any proof yet. We may think of North Korea as a backward nation, but in cyberattacks it is well advanced. They have been blamed for some of the most daring and damaging attacks, including the hacking of emails from Sony Pictures in 2014; theft of $81 million from the Central Bank of Bangladesh in 2016 and unleashing the Wannacry ransomware virus in 2017. Russia is a suspect because there was some evidence in the hacking of vaccines and attacks on the hospitals.

The attacks on American hospitals continue. Six hospitals in the Vermont health network were attacked. Griffin hospital in Derby had a major ransomware incident. Cyberattacks on America’s health systems have become a pandemic of its own kind. Why don’t we see too many reports? Because in many cases multimillion-dollar ransoms are demanded. It’s like family members not going to the media after kidnappers demand money to release hostages. For fear of losing reputation and patients, hospitals are trying to resolve the issues without making too much noise about it.   

In keeping with his character, Trump has complicated matters by sacking Christopher Krebs, the director of CISA, the cybersecurity agency responsible for defending critical systems, including hospitals and elections against cyberattacks. Mr Krebs disputed Trump’s absurd claims of voter fraud.

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Within the war against the coronavirus, there are several battles that need to be fought.

Ravi