Saturday, October 3, 2020

Corona Daily 309: The President in Isolation


In 1863, President Lincoln was diagnosed with smallpox. The White house was converted into a quarantine smallpox hospital. Lincoln’s two private secretaries imposed strict restrictions on visits. Dr Stone vaccinated all White House staff against smallpox. Lincoln famously said: for once in my life as President, I find myself in a position to give everybody something.

Trump is now another USA president with something to give to everyone, but nobody keen to take it. The White House now has over one hundred staff. Add to that his large family, including five children. Somebody took a wise decision to move him to the Walter Reed Army Medical Hospital. Its ward no. 71 has two suites, one for the President and one for the First Lady. But Melania remains at the White House.

Outside Trump’s presidential suite, a team of secret service agents in black suits, striped red ties and sunglasses will keep a vigil. The danger is not about a sniper, but a photographer with a long zoom camera. Trump can’t be seen in anything except in a smart blue suit. Any newspaper would pay a fortune for a ‘Trump in pyjamas’ picture. An oxygen mask or a saline tube would ruin any remaining election chances.

An attendant carrying the nuclear football will stand at the window. The football is a large and heavy briefcase containing the how-to-manual and a card with authentication codes to launch a nuclear attack. This briefcase is carried by military aides-de-camp, who must at all times be within earshot of the president. Just like the secret agents, they are subjected to strict scrutiny before recruitment. If out of sheer boredom Trump decides to launch a missile on Iran or Mexico, he will call this gentleman.

Trump has a daily meeting with the counselor to seek political advice. Trump is consistent - his wives and counselors are usually former models. Unfortunately, the current counselor Hope Hicks is down with the virus, and was possibly the source. In the large suite in the hospital, Trump will miss her presence.

There is also the make-up-team. Just like the royal families, each member of the Trump family has their own makeup personnel. Before Trump leaving the white house, giving a rally speech, starting the debate, the make-up team works on his face and hairdo. They remove any excess hair in his ears and nose. (Because Trump is tall, excess nose hair would look awful to those coming close to him.)  They check the tie-knot is perfect. Trump will miss this team. Their absence is another reason why nobody should take a picture of him.

Another person he will miss is the Twitter assistant. The twitular king is prolific, but he can only post text, even in BOLD. He can retweet on his own. But for the attachments, and to maintain his Twitter account, he has a full time assistant. Research doesn’t disclose who the person is, but it could be a girl in her twenties who was a model before becoming the Twitter assistant. If you see fewer tweets over the next two weeks, that may have little to do with Trump’s health.

Naturally, Trump will not be expected to engage in cooking, cleaning or laundering. People in PPE will bring him cheeseburgers and cokes. Doctors and nurses will monitor him, again wearing PPE. The secret service agents, if they are smart, will make sure nobody carries their smartphones when entering the suite.

In his 74 years of life, Donald Trump will be imprisoned in an isolation cell for the first time. Even those who don’t like the man, can take pity on him.

Ravi 

Friday, October 2, 2020

Corona Daily 310: Something Positive about Donald Trump

 


This morning Donald Trump tested positive. In my article dated 18 June, I had raised the possibility of the virus playing an assassin if power-hungry candidates become reckless during the campaign. Trump is tested daily. As is well known, the cunning covid virus enters the host first, symptoms appear only later. We will need to wait until the next week to understand the gravity of the infection. Trump and Biden are high risk - jointly they have lived for more than 150 years. Trump is obese and information about his medical conditions may be locked up in the same safe where his tax returns are.

*****

What happens if Trump becomes severely ill?

Trump can invoke section 3 (amendment 25), by sending a written declaration to the Congress appointing Mike Pence as an acting president. When Trump recovers, he can send another letter, and take charge again. Reagan (1985) and junior Bush (2002/2007) invoked this section before their colonoscopy operations.

Section 4 (amendment 25) allows Pence and the cabinet to inform Congress about Trump being incapacitated, physically or mentally. Funnily enough, if invoked because of Trump’s mental disorders, Trump can contest. And the Congress must vote him out by a two-thirds majority. But if Trump is on a ventilator or deeply sedated this section will be invoked, and Pence will become the acting president.

*****

What happens if Trump dies?

There are four important dates that create different scenarios. (I will refrain from using the word deadline). 3 November/ 14 December/6 January and 20 January.

3 November is the voting date to elect the President, the Senate and the House of Representatives. It is the big day. But the American system is bizarre, people vote directly, but they don’t elect. They send electors from the state (in proportion to the state’s size) to vote for the president.

14 December: is when the electors will vote. By convention, they must vote as directed by the people.

6 January: Congress, the newly elected and not the lame-duck Congress, will count the electoral votes and declare the winner. At this point Trump or Biden would become a president-elect.

20 January: With the inauguration, the president will assume office.

*****

If Trump were to die before 3 November, the Republican Party National Committee will replace him with another candidate. It doesn’t have to be Mike Pence. (Same with Biden, Democrats will nominate another candidate).

There is no precedent. In 1912, James Sherman, a vice-presidential candidate died six days before the election. His name was simply removed from the ballot. However, his ticket lost the election, requiring no further action.

*****

If Trump wins, but dies before 14 December, it creates crisis and chaos. Laws of several states compel the electors to vote for the winner, but voting for a dead person is not really fashionable. The electors may agree to replace the dead man with the Vice-president, but they may not. It will likely end up in the courts.

*****

If Trump wins, but dies between 15 December and 6 January, Congress may refuse to count the votes given to a dead candidate. If the president-elect, House of Representatives and senate belong to Republicans, the party may decide to elevate Pence to the president’s position, but it may not. After all, American people haven’t voted for Pence as a president.

*****

If Trump wins and dies any time after 6 January, 2021, before or after the inauguration, Mike Pence automatically becomes the president. Lyndon Johnson became one when John Kennedy was assassinated.

*****

Mike Pence/ Kamala Harris must hope and pray that Trump/ Biden don’t succumb to Covid until 7 January 2021. After that, either Pence or Harris has a good chance of becoming the President without anybody voting for them as such.

Ravi

Thursday, October 1, 2020

Corona Daily 311: Who Infects Who

 


India is generally associated with numbers that boggle the mind. It has 900 million voters, adds 13-14 million people every year, in ten years it will become the first country with 1.5 billion people. Not surprisingly, the largest contact tracing study ever was conducted in India. Its results were published yesterday. Researchers from American universities worked with the public health officials in two southern Indian states. Andhra Pradesh and Tamil Nadu together have 128 million people, and are among the most affected, or infected, Indian states. The researchers analyzed nearly 85,000 cases and 600,000 of their contacts to understand who infects who.

The study has at least five important takeaways.

*****

First, the ability of a few to spread the infection widely. The study found that 5% were responsible for 80% of the infections, while 71% didn’t pass the virus to anyone else. The Pareto principle (80/20 rule, e.g. we wear 20% of our clothes 80% of the time, and 80% only 20% of the time) seems to apply to the virus-spreading. Immunity or the lack of it may explain the ability of the person to “take in” the virus. For reasons not known yet, some people have a superior ability to “give away” the virus. If we were to find a way to recognize such super-donors, it may become possible to isolate them to curb a surge.

*****

Second, deaths in these two states increased with age, as can be expected, but dropped off after 65. This is good news for the 70+ and 80+. The possible reason is India’s life expectancy which is 69. (USA is 79). Remember 69 is the average. Many poor people, or those with little access to health care, die by 65, with or without Covid-19. Those Indians who survive beyond 70 are relatively better-off, with access to India’s best doctors and hospitals. That may explain why many elderly Indians are surviving infections. In the two researched states, until 1 August, only 18% of the deaths were among individuals older than 75. (In the USA, 58% of the dead were older than 75).

*****

Third, among those who died, the time between hospitalization and death was only 5-6 days. (USA 14 days). It suggests patients are brought to the hospitals too late, or due to being overwhelmed, hospitals admit only the most serious cases.

Among the dead, 62% had at least one co-morbid condition (USA 22%). Nearly half of Indian patients had diabetes, and one third had hypertension.

The Death rate was higher among men, a well-known fact. Men accounted for 62% and women 38% of the deaths.

*****

Fourth, index cases, the initial infectors were mainly men. They passed it on to others younger. It is possible Indian men move around more than women. Also, when the contact tracers call over the phone, it is likely the men talk to them more often than the women.

The elderly passed on the virus to people their own age. Not surprising that people similar in age mix with one another.

*****

Fifth, children of all ages can get infected and can spread. More than 5300 children in the study had infected 2500 contacts. Again, just like the elderly, children spread the virus to other children of a similar age. Possibly important information for the education minister before reopening schools.

*****

The research reported that India’s strict countrywide lockdown benefitted in reducing transmission. Tamil Nadu and Andhra Pradesh have better public health. The study must be considered as the best case scenario, before translating the results to another Indian state.

Ravi

Wednesday, September 30, 2020

Corona Daily 312: Temporary Children

 


Sixteen years ago, during a casual chat, my English professor, S, mentioned he was raising eight children – two his own and six he was fostering. As an Indian, I knew little about fostering. These were children, needing care and protection, placed under the guardianship of foster parents. Until then, S and his wife had fostered 27 children in total.  

How can someone teaching at university afford to take care of so many children, I asked bluntly. The government pays well, S said. In fact, for families courageous enough to foster, that is an incentive.

*****

UK has about 60,000 and USA 450,000 children living with foster families. These two nations have the most developed systems, independent agencies, and a government budget that usually pays a non-taxable, non-reportable sum per child. Monthly board rates are variable, $700-$1000 per month per child in the USA, and double of that in the UK. Children can be of any age from birth till 18 or 21. On reaching adulthood, they are expected to take care of themselves.

A child may have suffered abuse; physical, mental or sexual, may be neglected or abandoned. The child’s parents may be arrested and jailed. Older children may be involved with juvenile crime, substance use, trauma or have run away from home. Agencies supported by the state take their responsibility and place them for fostering until they can return home. If the courts decide they can’t return home (e.g. abusive parents unlikely to improve), those children are offered for adoption. The foster parents will take care of the children, until someone adopts them. Fostering can happen over days, months or years. (This BBC story about a foster child will make even insensitive people cry).

Volunteers offering to foster undergo a lengthy scrutiny. Social workers visit their homes, gather information, check absence of criminal record. After placing the children, regular visits are done to check everything is in order.

*****

Yesterday, I wrote about children of divorced or separated parents. Children in foster care are another group affected by the pandemic.

Economic hardship and domestic violence meant more children needing care outside their home. An Irish agency reported a 37% surge, a figure similar to places in the UK and USA. Hundreds of foster children have been in limbo waiting for court hearings, suspended for many months. The state departments cancelled face-to-face visits. Children waiting for courts to determine whether they should return home or be offered for adoption could not see their parents. Some independent fostering agencies closed their doors to new children to avoid the spread of Covid-19.

A tough part of fostering is children “ageing out” of foster care. They must leave the home of their foster parents on reaching adulthood. In normal times, they look for an hourly-wage job and manage to find their way in life. Now jobs at McDonalds and Starbucks are also not available. In times of a stay-at-home order, they face homelessness. Since the state withdraws financial support after their eighteenth birthday, the foster parents are often not in a position to afford them. (Many have their own children to look after as well).

*****

The silver lining is the increasing number of families who are now coming forward to start fostering.  Some childless couples, as well as couples with children, had toyed with the idea, but there was never the right time. This pandemic has provided them an opportunity. Many work from home, some have lost their jobs. Fostering terms are flexible. One can apply to foster for three to six months as well.

A pandemic is sometimes capable of bringing the best out of people.

Ravi

Tuesday, September 29, 2020

Corona Daily 313: Mom’s House or Dad’s House?


Last month, a superior court of justice in Ontario, Canada had to rule on whether a father can exercise his rights and spend time with his daughter during the summer holiday.

Almaz Yohannes, the mother, lives in Toronto. Her ex-husband Florent Boni lives in France. They divorced in 2012. Their 10-year old daughter Selyana lives with her mother in Toronto. Selyana spends her school breaks, including six-weeks of summer holiday with her father in France. On hearing the mother was reluctant to send Selyana to France in these pandemic times, the father went to the French police complaining about the non-compliance of the order by his ex-wife. The mother then brought an urgent motion requesting the Ontario court to suspend the father’s rights during the pandemic.

The court decided that it was in Selyana’s best interest not to travel to France until the Covid-19 pandemic continued and the Travel Advisory was in place. Considering the extraordinary circumstances, it was practical to change the original parenting order. The father can exercise his access to Selyana in Toronto when he visits in the future.

The judge, who decided the case through a videoconference, also expected the parties to co-operate.
***** 

Counselors and courts expect parents to co-operate, but in many cases the parents divorced because they couldn’t. 

Even when divorced or separated parents live in the same city, co-parenting has become complicated. In the USA alone, there are 8.3 million children co-raised by estranged biological parents. The historical norm of sole-mother custody is now replaced by equal or equitable custody. A child moves between two houses, staying for three days in one, four days in another every week. Some children spend alternate weekends with their father and mother. They don’t ever say “I’m going home”. It’s either “mom’s house” or “dad’s house”.

Since March, the children and their parents have faced several problems. Normally, the house swap happened at the school or a parent’s workplace. Now kids must be collected and dropped at the ex’s house. With restricted movement in lockdown, it was not clear if the agreed terms can be abided by. Michael Gove, the UK minister, had to clarify the lockdown restrictions didn’t apply to movement of minor children living in two houses.

A real frustration in co-parenting is that you don’t know what goes on in the other house. Is your ex’s new family as careful about handwashing and social distancing? What if the ex-husband’s now-wife is a nurse?

Family courts were initially closed, later virtual. For them, the joint custody disputes are not a priority over domestic violence cases. Courts worldwide take interference with custody and visitation seriously. A nasty parent can even file charges of kidnapping against the ex for not following the parenting order. Where relations are not cordial, co-parents are worried about unilaterally changing the agreed arrangements.
***** 

Chloe Caldwell, 34, writes for New York Times. She stays with her stepdaughter, Louise, 10. For half a week, Louise moves to her mother’s house, where the mother lives with her current husband and children.

Since March, Louise started sleeping badly; many children do in the pandemic. She asked for a puppy as a companion. Chloe and her husband were not keen, but Louise’s mother was. In June, on Louise’s tenth birthday, her mother gave her a fluffy pandemic puppy, Bella. Caldwell’s poignant story about co-parenting a puppy ends happily with both Louise and Bella now moving every week between the two houses.

Ravi

Monday, September 28, 2020

Corona Daily 314: The Nightingale Court


The Lowry, named after an English artist, is an impressive theatre and gallery complex in Salford, Greater Manchester. Its two drama theatres with a total capacity of more than 2000 seats have been completely shut since March.

Today, for the first time, the Lowry theatre will reopen. From its wings, a judge will appear all dressed up exactly as the English judges should be. He will occupy a throne below a huge coat of arms suspended in the air. The judge will be given his own dressing room on a lower floor. Jurors will sit not on the stage, but in the auditorium. The best seats in the auditorium are reserved for them; each juror is allocated an entire box designed for six people.

The sound booth at the back is removed – the defendant will sit there. He will be clearly visible to the judge and the jury; there will not be a bullet-proof dock.

Airport-like scanners are placed at the theatre entrance. The judge, jurors, the defendant and anyone else wanting to attend will walk through these scanners.

The theatre lighting will be very sober and unchanging. No spotlights will be used for either the prosecutor or the defending counsel.

Julia Fawcell, the Theatre’s CEO explained it by saying: “Coming to court is a serious business. It is very important that there is dignity and accountability.”
*****

Like theatres, England’s courts too had shut down in March as well. By 23 August, England’s crown court gathered a backlog of 46,467 cases, and the magistrates’ court had 517,782 pending cases. The backlog situation was severe before the pandemic, now it threatened to become catastrophic. Criminal courts wanted to use digital hearings. This was condemned as violating the fundamental principle of open justice which requires hearings in the presence of public. The justice secretary proposed reducing the number of juries to 7 (instead of the twelve angry men) or abandoning jury trials. These ideas were rejected. Defendants can be held in custody for six months. With trials stopped, that period was over for many. Judges were reluctant to extend their stay, particularly with the virus roaming about in the prisons.

With the passage of time, reliability of witnesses’ memory becomes an issue. Also the stress for victims, witnesses, and the defendants assumes a chronic form.

Finally, the justice secretary announced the concept of the Nightingale Courts. Temporary courts to handle the backlog of cases. In July 2020, ten such courts began working. More staff was recruited, and technology rolled out. The Nightingale courts handle all non-custodial crime, civil, family and tribunal cases.

Today, courts will start conducting trials in the Lowry theatre, Hilton hotel York and Jury’s Inn in Middleborough. (The hotel name Jury’s Inn is a mere coincidence). The Lowry has offered three courtrooms, all holding daytime trials from Monday to Friday. The ministry of justice will pay an undisclosed amount to the Lowry and other venues. It is a crucial lifeline for the theatre which has lost £20 million in revenue this year.
*****

‘Slow justice is no justice’ or ‘justice delayed is justice denied’ are well-known clichés. Yet, in countries like the UK or India, the judiciary has been excessively conservative. Documents must be printed, notarized, and hand-delivered. The number of courts and trial rooms are horribly behind the population growth.  Countries still using a jury have a lengthy process to select them.

Fortunately, the pandemic is now forcing the judiciary to shed its outmoded ways. Virtual trials have started. And the UK has set an example with the Nightingale Courts that other countries must take note of.

Ravi  

Sunday, September 27, 2020

Corona Daily 315: Sophie’s World and the Coronavirus


One of the several mysteries of the current pandemic is the way it has spared children so dramatically. The number of infections among children, as compared to adults, is tiny. This phenomenon is uniform across all countries. A major study headed by Dr Betsy Herold published its results this week. When reading it, I was reminded of the novel Sophie’s World.
*****

Sophie’s World by Jostein Gaarder, a Norwegian writer, is a philosophy textbook disguised as a novel. Highly readable, this bestselling book introduces the reader, along with Sophie, to the history of philosophy.

In one place, the book talks about a toddler, who sees and hears a dog bark for the first time. The one-year old is excited, perhaps alarmed, because it has never seen a barking dog before. If the toddler were to see an apple shooting up from the ground to the tree, or its mother walking on the ceiling, it would not be shocked; it would simply store these new experiences. In that sense, pre-school children have a very open mind, because they haven’t yet learnt gravity in school. Children have no preconceived opinions. A child’s mind is a Tabula Rasa (clean slate).  

Adults however, become slaves of the expectations of habit based on their experiences and education. A barking dog is not an event to pay attention to, and if a magician makes an apple fly, they know it is only a trick of some kind.
*****

Dr Herold’s team studied 60 adults and 65 children (age under 24) in a New York hospital from March to May.

The study finds that the children’s “innate immune defence” is rapid and overwhelming. Compared to adults, children have experienced few viruses. As soon as a child’s immune system confronts the coronavirus, it becomes alert and starts fighting with all force.

Human beings have two types of immunity – innate and adaptive. Adults, over time, have experienced a series of viruses; their systems carry a large database of the pathogenic villains. Their response, called the “adaptive response”, is more virus-specific. The adaptive immunity tries to create antibodies and immune cells to target the particular virus.

Apoorva Mandavilli, in her New York Times article compares the children’s immune response to an ambulance that immediately starts working on the patient. The adults’ adaptive response is like that of the skilled specialists at the hospital.

By the time the adult gets the adaptive system up and running, the virus gains valuable time to inflict harm. In older adults, the innate system fades making them more vulnerable.
*****

This is not a speculative hypothesis. The children studied had much higher blood levels of two particular immune molecules – interleukin 17A and interferon gamma. The largest quantities were found in the youngest patients. Quantities declined progressively with age.

All viruses have their inbuilt tricks to evade the innate immune system, and the novel coronavirus is known to be particularly skillful. By producing interleukin-17 early in the course of infection, children seem to successfully defeat the virus’s attempts to avoid the innate response.

Dr Herold noted that most existing vaccine candidates focus on boosting the neutralizing-antibody levels. She suggests developers should consider vaccines that can promote immunity by bolstering the innate immune response.
*****

Adults, alas, can’t be children any more. But they can try to mimic how children defend themselves against the novel coronavirus.

Ravi

Saturday, September 26, 2020

Corona Daily 316: Numbers 53, 106, 151


Vaccine trials can determine only the starting date, never the end date. Because the end date is contingent on events beyond anybody’s control.

Trump is pushing for a pre-election deadline. It is like asking an obstetrician to successfully deliver a four-month pregnant woman’s baby. Feeling threatened, two companies, Moderna and Pfizer, decided to be excessively transparent with the public. Moderna’s 135 page confidential protocol is now displayed on its website. In it, Moderna gives its pre-programmed milestones – 53, 106, 151. What do these numbers mean?
*****

Moderna planned two shots each to 30,000 participants, four weeks apart. Participants are monitored to see if they develop symptoms of covid-19 and test positive. To determine the vaccine’s efficacy, Moderna counts cases two weeks after the second shot.

Moderna’s first milestone is 53 Covid cases - fifty-three in total, irrespective of whether the case was a vaccine or a placebo recipient.

Let us imagine an extreme case, where all 53 covid cases are placebo receivers but not a single vaccine recipient has contracted the virus. This is delightful news - the vaccine is effective, the trial can end and an approval be sought.

However, dreams are perfect and life is not.

At the other extreme is a possibility of all 53 cases occurring solely among the vaccinated group, and none among the placebo-takers. If this bizarre scenario were to happen, the trial will be abandoned, the developers sacked, and the company sued.

As is usually the case, the reality will lie somewhere between these two extremes, with positive cases emerging from both groups.
*****

How can a vaccinated person contract covid-19, you may ask. Well, vaccines - like humans - are imperfect. The most successful vaccine – the Measles vaccine - is 97% effective. But flu vaccines are only 40%-60% effective.

Covid-19 vaccines are rushed, and expected to protect against a truly novel virus. The FDA is willing to approve a Covid-19 vaccine as long as it is 50% more effective than a placebo. 70% is desirable but challenging.
*****

If a vaccine is going to be effective only 50%-70%, why take it? If despite vaccination, a person can still catch the virus, what is the point? The point is this: the target of the Covid-19 vaccination programme is to achieve herd immunity, more than protecting each individual. (Sorry for the disappointing news). A 70% effective vaccine will reduce transmissibility, allow people to move around freely, and bring us back to a life more or less normal. The case numbers will be small and declining. There will still be Covid-19 cases and deaths, but not outbreaks.

That is why it is essential as many people as possible get vaccinated to get to the 70% magic herd immunity number. And people will agree to the shot in the arm, only if they have confidence in the vaccine. And they will have confidence only if there is complete transparency, and the job is not rushed.
*****

When Moderna reaches the first 53 cases, and if the difference between vaccinated and placebo-ed is not significant, it will wait till 106 cases, the next milestone. The placebo cases should be at least double those of the vaccine cases. If this doesn’t happen at 106, the next number is 151 (0.5% of the trial participants). Moderna will not consider asymptomatic, mild cases. So how long it – and we - will have to wait is unknown.

Ravi

Friday, September 25, 2020

Corona Daily 317: The Importance of a Placebo


When we fall ill, what cures us? Medicines? Possibly.  But that is only one of three elements. The other two are: nature and our own mind.

I remember a saying. With medicines, a cold disappears in seven days. Without, it takes a week. Nature is the greatest healer and medical science tries to complement it. For minor issues like cold, cough, fever, stomach upset, headache a person can simply rest, and let nature take her own course. But doctors prescribe medicines because of their training and patients lacking patience take them. Smart bacteria have made many antibiotics ineffective. Clever doctors prescribe a course long enough for a timely cure by nature.

B follows A, therefore A must have caused B. This is called the post hoc fallacy. A village child hears the rooster crowing, and then sees the sun rising. The child is certain; the sun rises because of the rooster.

Did the medicine have any effect on your headache? To answer you must ask: what would have happened to the headache had you not taken the medicine? This is the purpose of a placebo. Take two friends with a bad headache. (Maybe they drank together last night). Give a real pill to one, and an identical looking dummy pill (placebo) to the other. If by evening, both heads feel fine, then obviously the medicine was unnecessary.
*****

Other than nature and medicines, our mind is the third doctor. If a person with a headache believes the pill would help him, even the dummy pill may help. This is called the placebo effect. Placebo medication has been shown to reduce pain because the patient’s belief activates the endogenous opioid system in the brain.

God is an excellent example of a placebo. A student sincerely praying before an exam, or a sportsman asking God’s blessings may truly excel in their performance. God is a placebo medicine, because nobody has seen the real medicine.
***** 

Coming to the Covid-19 vaccines, you may have heard that the trials are randomized, double-blind and placebo-controlled. This is the gold standard without which a vaccine will not be approved.

Half of the volunteers are given a real vaccine (experimental group). The other half is given a placebo vaccine (control group). The thousands of trial participants have no idea if they were given a vaccine or a dummy jab. That is a single blind. But the doctors/ nurses who administered them don’t know it either. That is why it is a double-blind trial. (The database has the record of who is who).

To further remove any bias, the allocation of vaccines and placebos is done randomly. Without blinding and randomization, a doctor may be tempted to give placebos to healthy volunteers, and real vaccines to less healthy ones. That could distort the results.

It is important a volunteer doesn’t know what he is given. Oxford gives a meningitis/ septicemia vaccine as a placebo. That way there is muscle pain, soreness, redness and swelling where the needle went in. Of course, it will do nothing against the coronavirus.
*****

Giving a placebo is always an ethical issue. Informed consent is obtained from all the participants. Everyone has a right to withdraw from the trial at any stage. If someone who has received a placebo vaccine falls ill with Covid-19, he will be treated on a priority basis.

In fact, for the success of the trial, it is critical that a number of volunteers should fall ill with Covid-19. Tomorrow I will explain why.

Ravi

Thursday, September 24, 2020

Corona Daily 318: Place Euphoria in Frozen Storage


I meet lots of people who are euphoric about Covid-19 vaccines. With the amount of investment and dozens of candidates running trials, the world will get a vaccine anytime soon, signalling curtains on the pandemic. Pfizer has one of the three vaccines that have advanced to phase 3 trials. God forbid Pfizer wins the race by getting approval for its vaccine. Why so?
*****   

Vaccines travel a long way from the factory to the injectible arm – often across continents. Most standard proven vaccines need to be maintained at temperatures between 2C (36F) and 8C (46F) throughout the cold chain. If the vaccine becomes too warm for too long, it can become ineffective. (These two documents state in lovely details: all that you ever or never wanted to know about cold chains.)

Now along comes Pfizer and develops a Covid-19 vaccine that must be maintained at -80 C (-112 F) throughout the cold chain. Great if all of us were living on the South Pole. Fedex had invested in freezers for the 2009 H1N1 epidemic, they have doubled their capacity. UPS is building a freezer farm with ultra-cold freezers to store millions of doses.

Additionally, staff has to be trained and equipped. You can’t operate the freezer unless you are wearing personal protective equipment (not to be confused with the Covid PPE), specific gloves and special goggles. Of course, you can’t invite the whole world to a farm in Louisville to get vaccinated. The special operators must take the vaccines out to the trucks.

That has to be done with dry ice. But dry ice on flights needs special approvals. Because when it melts, it emits carbon dioxide, potentially making the plane unsafe for pilots and crew.

The trucks, planes, warehouses, clinics, chemists will require dry ice. Dry ice is made of CO2, which is a byproduct while producing ethanol. The demand for ethanol moves in line with gasoline. But people are driving less, so the ethanol production has slumped. As a result, dry ice is in huge shortage.
*****

Meanwhile, the American glass company Corning has warned that glass cracks in such extreme cold. Meaning the glass vials will be defunct. Corning is now developing a new type of glass that can withstand these temperatures.

In theory, the Pfizer vaccine can be shipped in “dry ice pack” boxes. But that dry ice will need to be replenished within 24 hours of receipt. The shipping carton must be closed within one minute of opening, and should not be opened more than twice a day. Again, dry ice handlers need to be trained at all stages, because of the risk of asphyxiation.
*****

Your chemist or GP is unlikely to invest in the necessary equipment. Even in developed countries, the probable scenario is people going to a centralized location, such as a hospital with great super freezers, and queuing up for a vaccine. With such stringent cold chain conditions, only 2.5 billion people in 25 countries would be able to access the vaccine. About 5.5 billion people in 180 countries in Asia and Africa will be deprived for lack of infrastructure.

Globally, half of the vaccines are wasted because of the supply chain logistics. India, a developed vaccine country, wastes 25% as a minimum, and up to 50% of BCG vaccines. Reliable electricity supply is key. In Uganda, 70% of the health care facilities have electricity going off for a few hours every day.

Moderna vaccine is slightly warmer, requires -20 C (-4 F). Oxford and Johnson and Johnson vaccines expect normal 2C-8C conditions.

People living in areas with unreliable power supply should not be euphoric about the potential vaccine.

Ravi