Vaccines, Reality, and Russia

Russia has announced it now leads the world by being first with a tested, safe and effective vaccine against Covid-19.

Jokes (and there have been a few) aside, how real is this? Could this vaccine, or any other, be ready, tested, safe and effective anytime soon.

  • Russia, The Jokes, The Reality
  • Is a phase 3 trial essential?
  • Why do 95% of Vaccines fail at stage 3?
    • Payback – Benefits.
    • Payback – Time Limits
    • Risk: Negative Consequences
    • Only 5% worth it?
  • Conclusion: There will be a vaccine, the question is ‘how effective?’

Russia, The Jokes, The Reality

When I first heard the story the Vladimir Putin had announced Russia had a vaccine, and that it was so safe it had even been tested on one of this daughters, it prompted some questions:

  • what…. one of his daughters, apparently he has two daughters?
  • does that make this daughter the favourite… or not the favourite?
  • if the vaccine is that safe, why not both daughters?
  • or perhaps more tellingly, why has Putin himself not tried the vaccine?

Mr Putin told the meeting: “I know that it works quite effectively, it forms a stable immunity and, I repeat, has passed all the necessary checks.”

Mr Putin told the meeting: “I know that it works quite effectively, it forms a stable immunity and, I repeat, has passed all the necessary checks.”

Mr Putin said that the vaccine had even been administered to one of his daughters.

He also said he hoped the country would start mass-producing the vaccine soon.

From the UK Express

It is understood the couple had two daughters together, Maria and Katerina, who are both in their mid-30’s now.

Mr Putin did not state which of his daughters has received the COVID-19 vaccine.

But Mr Putin did state that his daughter had a temperature of 38C on the day of the first vaccine injection, and then it dropped to 37C the next day.

After the second vaccine she again had a slight increase in temperature, but then the symptoms went away.

Mr Putin added: “She’s feeling well and has a high number of antibodies.”

From the UK Express

Little is known about these two daughters as Putin normally goes to extreme lengths to avoid their being in the spotlight, but as they are in their 30s and are likely to have more freedom than many Russian citizens, any decision to join a trial was very likely a decision of the this daughter independently of her father. The thing that is out of character is Putin telling about it.

Reality is there is insufficient documentation to say there has yet been a full conclusive phase 3 trial of this vaccine. In fact, it seems most likely there has not. Phase 2 normally already checks the safety levels expressed in the the statements made, so could Putin be correct in saying that the vaccine has “passed all the necessary checks”. In other words, is a full phase 3 trial necessary, given passing phase 2 already tests for safety in humans, and that the vaccine produces an immune response?

Is a phase 3 trial essential?

Yes and no. Essential before manufacture, or deciding who gets it?

No? A full phase 3 trial is not needed before manufacturing can start. Vladimir Putin said “hoped the country would start mass-producing the vaccine soon” . So production has not started. Note that the ‘Oxford’ vaccine, still undergoing phase 3 trials, is already in production. Production prior to stage 3 trials risks that production being a waste if the vaccine is no longer wanted after stage 3 trials are complete, but saves time in having the vaccine.

Yes! A full phases 3 trial is needed to decide who should receive the vaccine. Before phase 3 can even start, the vaccine must have been already determined sufficiently to be sufficiently safe to give to the large number of people needed for the phase 3 trial. The main thing that is not known at the outset of the phase 3 trial, is the benefit of giving people the vaccine. Yes, the vaccine is already known to trigger an immune response, but the immune system is complex. Will this immune response last, and will it help once a person is then infected with the virus?

Given vaccines for Covid-19 are being produced in advance of completion of stage 3 trials, why not ‘approve’ the vaccine as well? Normally, approval sets parameters as to how the vaccine can be used, by avoiding being that specific, the ‘approval’ in Russia may mean little other than very tenuous bragging rights.

Why do 95% of Vaccines fail at stage 3?

Payback – Benefits.

There are 5 different possible successful outcomes, even from a successful vaccine:

  1. immunity from infection
  2. immunity from resultant disease
  3. immunity from serious disease
  4. no noticeable difference
  5. infection outcomes are more serious when vaccinated

The goal of stage three trials is to determine what percentage of people experience which outcome. Ideally 100% experience immunity from even being infected, but in reality, even some people having worse outcomes may not disqualify a vaccine if cases are sufficiently rare.

The ultimate is where vaccinated people are immune to even being infected by the virus. This the ultimate, but is a relatively rare outcome, and as it requires the immune system to be permanently on alert, may be associated with the greatest risks to the immune system itself or autoimmune conditions. However, even with Covid-19, it should prevent spread.

Immunity to the resultant disease is a more likely goal, even though with Sars-COV-2 this may not completely prevent spread. It is far more common to be able to have an immune response from the vaccine that enables the immune system to quickly suppress the virus, and prevent those infected becoming ill.

Immunity to severe disease is a ‘lower bar’ that still may be acceptable.

Some people may see no benefit from being vaccinated, and some people may even have worse outcomes with a ‘primed’ immune system. Consider the situation with children who have ‘overactive immune response’ as a result of Covid-19.

Some cases with no improvement, or even worse outcomes, when vaccinated may not disqualify a vaccine if sufficiently rare.

Payback – Time Limits

It is very difficult to be certain how long immunity lasts following infection with the virus resulting in Covid-19, and the virus has been around for 8 months now, with millions and millions of people as a source of data. How long to be certain of the duration of immunity from a vaccine, given trials are on a far smaller scale?

Risk: Negative Consequences.

No vaccines there is no evidence vaccines cause autism, but that doesn’t mean they must always be harmless. The most likely problem is producing some of the same negative outcomes as the disease being vaccinated against. Particularly when that negative outcome from the disease is a result of the immune response to the disease, as has been seen to happen with some children and Covid-19. This problem can take months to occur following a case of Covid-19. Could it occur in even more people after even more time passes? Perhaps it just takes longer in adults? There are so many unknowns with Covid-19, and some of the risks are still relevant with a vaccine.

Risks: Beyond the disease?

Diseases normally infect only a percentage of the population, while vaccines are intended to be given to everybody. And if the vaccine provides protection for a limited time, it may have to be given over and over. The greatest risk from the vaccine would be for children, who might be given the vaccine many times over their entire life. On the other hand, children are statistically at less risk from Covid-19 itself. This makes the equation on when any risks are justified different from person to person. Further, the longer any vaccine has been in use, the more certainty with respect to risks, meaning who should get the vaccine may also change over time.

Only 5% worthwhile?

There are not 20 vaccines at stage 3, so it may seem against the odds for even one vaccine through stage 3. I suggest the odds are far better with Covid-19. Most failures come down to the cost equation: the result simply does not justify the cost. With Covid-19, the payback potential from a vaccine is higher than with almost any vaccine in the past. This makes the chances of the equation for a vaccine being favourable far better than ever before.

Coronaviruses have proved a challenge to vaccines in the past, but at least the mutation rate is slower than with influenza viruses. On the other hand, a vaccine that just reduces the severity of Covid-19 in 50% of cases would still be worth producing.

Conclusion: There will be a vaccine, the question is ‘how effective?’.

I have heard a news reporter describe ‘the race for a vaccine’. There can be an implication that having a vaccine is a fixed destination. I suggest it is more like entrants racing to reach their chosen holiday destination. Not all destinations are equivalent, nor are all vaccines.

There will almost certainly be a vaccine, just as everyone can still have a holiday.

Yes, typically, 95% of vaccines do not get through stage 3 trials, but this is not because 95% are a complete failure, and Covid-19 is not ‘typically’. That 95% bundles the complete failures with a larger number that work, but do not justify the logistics and cost of a vaccination program. Just as how camping in the garden may not normally qualify as a holiday destination, there is an appetite for anything that works at all as vaccine for Covid-19.

Given the appetite for a solution, perhaps 60% of typical results would be sufficient to get production of the vaccine funded when Covid-19 is the problem. Of course, this includes vaccines that normally would be said to be ‘marginal’. We will have at least one vaccine, but even the best vaccine, may not prevent spread, may not protect everybody, and may not give long-lasting protection. Or we could have a vaccine that meets all those goals.

The question is not “will there be a vaccine”, but “how effective will be even the best vaccines developed”.

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