Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Saturday, October 24, 2020

Why A Covid Vaccine Will NOT Lead to a Return to Normal

First, there has been considerable socioeconomic and political fallout from the pandemic and the failure of governments to protect their citizens, both physically and financially, that will forever change how people interact and earn a living. Many businesses have gone under and will never return. It’s been estimated that 50% of all U.S. restaurants and museums will never come back. Many businesses are realizing they function just as effectively with their employees working from home, so why return to office building and continue paying rent and utilities?

But from a purely medical perspective, the idea that a vaccine will suddenly or even slowly allow us to gather in large crowds without masks may be pie in the sky, and here’s why:

1.      For things to truly go “back to normal,” which I believe, for most people, means being able to gather in large groups, indoors, without masks, without obsessive handwashing, without anxiety that anyone in the room might be another super spreader, AND being able to send their kids back to daily, 100%, in-person school, there would have to be enough immunity in the population for the virus to die out and disappear completely. Experts use the term “Herd Immunity” to refer to this condition.

2.      We have fully achieved herd immunity with Smallpox, which is now considered extinct, through a combination of an incredibly effective vaccine and an incredibly effective worldwide collaboration to distribute and administer the vaccine. We’ve come close to eradicating Polio. The reason we have not is due to several factors, including governmental policy failures in several countries, but also because Polio immunity is much more complex than Smallpox immunity and creating effective vaccines has been much more difficult. Similarly, with mumps, measles, rubella, diphtheria and many other deadly scourges of past centuries, we’ve come close, but because of anti-vax hysteria (people refusing the vaccines for their children out of the irrational and scientifically debunked fear that the vaccine was more dangerous than the disease), outbreaks continue to crop up.

3.      To reach herd immunity, we need 60-80% of the population to be immune. Herd immunity means that enough people have acquired immunity that the virus can no longer take hold in the community, even though some people may still be susceptible.

4.      Problem #1: we still don’t know how effective the Covid-19 vaccine will be. If it’s 70% effective (meaning 70% of those who get it will develop immunity) and 80% of the population receive it, the result will be 56% of the population develops immunity (70% x 80% = 56%)—probably too low to reach herd immunity.

a.      The FDA has said it will accept any vaccine that proves to be safe and at least 50% effective. Yet no manufacturer has yet completed their studies and published any data on their vaccine’s effectiveness, so this is still a big unknown.

b.      50% effectiveness won’t get us close. Even if 100% of Americans get a vaccine that’s only 50% effective, we’d end up with only 50% of the population acquiring immunity

5.      Problem #2: In the U.S., over 20% of the population has vaccine hysteria and has said they will refuse any vaccine, period, end of story. Another 30% is still on the fence. According to CIDRAP, roughly 51% of Americans said they’d get the vaccine. And in the most recent studies of people's willingness to take the vaccine, researchers found that only 51% of people would take the vaccine if it's only 50% effective, and only 61% if the vaccine was 90% effective. Both of these rates are too low to create herd immunity. So, if we do nothing to change this (as we’ve done so far), that leaves only 40-50% of the population that would get vaccinated. So, even if the vaccine is 100% effective (and no vaccine is), we will end up with only 50-60% of the population acquiring immunity, which is far too low to reach herd immunity. This could change, easily, with an effective and vigorous public health outreach campaign (e.g., TV, billboards, social media, etc, promoting how the road to normalcy is developing herd immunity, and the quickest way to herd immunity is for everyone to get vaccinated), combined with strong public health policies (e.g., no one is allowed into school or the workplace without proof of having been vaccinated).

6.      Problem #3: We don’t yet know if the covid-19 vaccine will produce full or partial immunity. Coronaviruses, in general, and covid-19, specifically, tend to produce partial, short-term immunity in those who have been infected. Consequently, people can, and have, caught Covid-19 twice. And the second bout can actually cause worse symptoms than the first one. Vaccines tend to produce more robust immune responses than actual infections, due in part to dosing and the use of adjuvants. Even so, the covid-19 vaccine might still only produce partial or short-term immunity and/or require regular boosters. If this is the case, it would be much hard to reach herd immunity, as people would have to remember to go in for their regular boosters.

7.      Problem #4: Coronaviruses are RNA viruses (they contain no DNA), which tend to mutate and evolve at a much higher rate than DNA viruses (like pox viruses). Consequently, we may be faced with new strains and even new species of deadly coronaviruses each year, requiring completely new vaccines each year, as is the case with influenza. Many of the vaccines currently under testing for covid-19 are designed to recognize the spike protein common to all coronaviruses, which, theoretically, would protect us against all new coronaviruses, but it remains to be seen if this will in fact be true. It is entirely possible that covid-19, or some other coronavirus, will evolve the ability to evade the vaccine.

8.      Problem #5: Vaccines often have varying degrees of efficacy in different age and health cohorts. For example, the covid vaccine might be 80% effective for healthy 20 to 50-year-olds, but only 40-50% effective for infants and toddlers or for those over the age of 80.

9.      Problem #6: Even if one of the vaccines completes its clinical trial by the end of the year, it could take another 6-12 months before enough can be produced and distributed to the general public. So, even if it turns out to be 90% effective, and even if 70-90% of the population agree to take it, masks and distancing will not be going away soon. Some experts are saying we should brace for another 2-3 years of masks and social distancing.

 


Sunday, October 4, 2020

Teachers Are Expendable Commodities for Capital; They Will Be Among the First to Receive New Covid Vaccine

Capitalists make their profits by paying workers less than the value of the goods or services they produce. The math is pretty simple. The less they are given in wages and benefits, the greater the profits. However, bosses can't pay us nothing. If we starve to death, we can no longer produce commodities or earn them profits. Furthermore, if we're dead, we cannot buy their products, either. What about K12 teachers? We don't produce any goods or services that are sold for a profit. But we do two things that are essential for capitalism: (1) we provide free babysitting for other workers and (2) we train future workers to have the basic skills necessary to labor and consume. Hence, the hysterical demands of politicians at all levels of government to immediately reopen K12 schools across the country, despite the high infection rates and regular outbreaks stemming from these openings.


There is, of course, a solution, both to the safety of K12 schools, as well as the economic and health crisis facing the planet: END THE PANDEMIC. 


This can, theoretically, be accomplished with an effective vaccine, which we are supposedly close to having. The Protocols for Equitable Distribution of Covid Vaccine, written up by the National Academies of Science, Engineering and Medicine, has placed K12 teachers near the top of the list for highest priority to receive the vaccine. Phase 1a would vaccinate high risk health workers. Phase 1b would vaccinate high risk, comorbid members of the community. And Phase 2 would vaccinate all K12 teachers. These groups would be the highest priority Americans to get the vaccine, well ahead of K12 age school kids, their families, and well ahead of other high risk, truly essential workers (e.g., those in the food production and distribution industries).


So, if we are perfectly capable of teaching safely from home, as we have done throughout the country, now, for 5 months (including last spring), why give teachers higher priority than say Amazon warehouse workers (20,000 of them have already been infected), or meat packing workers (dozens of them have already died from Covid).

ANSWER: They want all of us back in the class room for 100% in-person teaching (as they always have) for that free babysitting, so that everyone else can go back to crowded, unsafe indoor jobs (before it is safe to do so) or to jobs that no longer exist.

But why should I complain? As a teacher, I'd get protection well before the rest of the country. I'd be able to go back to my normal life, eat at indoor restaurants, get tattoos and massages, hug strangers, and not feel the slightest anxiety over contracting coronavirus.

Here are some reasons to be concerned:
  1. They may be rolling out the vaccine prematurely, before it has been adequately safety tested, as prompted by Trump's demand that it be made available immediately. Originally, experts, like Fauci, were saying that spring or summer 2021 would be the earliest it would be ready. Now they are saying it could be as early as Nov or Dec 2020. So, is it safe? Have they done sufficient testing? If so, why were they originally saying it would take another 6-8 months to adequately safety test it?
  2. No vaccine has ever been 100% effective. The rules for this vaccine are that the feds can only approve it if it is at least 50% effective (i.e., 50% of those who receive the vaccine gain full immunity). I have not seen any published reports about how effective any of the covid19 vaccines are that are currently being tested. However, if we are given a vaccine that is only 50% effective and forced back into the classroom before the general public has been vaccinated, 50% of us will still be vulnerable to being infected by our students.
  3. I have likewise seen no published data on how long-lasting the immunity is through vaccination. Generally, vaccines produce more robust immune responses than one would get from an actual infection, but what if this vaccine still only provides short-term immunity, like one gets from an actual covid infection?
  4. Lastly, a full 20% of the public has flatly refused, preemptively, to take the vaccine, while another 31% are unsure if it's safe and leaning toward refusing it (see here , here, and here). The feds have done nothing to educate the public or to sway this 31% who are on the fence. So, even if the vaccine was 90% effective, but only 50% of the public took it, only 45% of Americans would gain immunity.
Therefore, teachers need to stay vigilant and start preparing several defenses: 
  1. Demand that no teacher be asked to return to the classroom until EVERY student has been vaccinated and REFUSE entry to ALL students who cannot prove they've been vaccinated (like we currently do with MMR, Pertusus, etc).
  2. Demand transparency on the effectiveness of the vaccine (What percentage of vaccinated patients acquire immunity? AND how long does that immunity last?) and its safety
  3. Demand that the return to in-person teaching be optional (teachers who feel they are at higher risk be given the choice to continue teaching from home)
  4. Demand that other safety protocols continue until the pandemic is truly over (masks; social distancing; smaller class sizes; daily health checks at the front desk) and NOT assume that the vaccine has solved the safety problem

Sunday, May 3, 2020

Remdesivir: Panacea for Wall Street or Sick Americans?

Remdesivir has been fast-tracked by the FDA to be used as a "frontline" treatment against Covid-19. In an emergency-use authorization, they claim the benefits of using the drug, without having complete data from the NIH clinical trial, far outweigh the risks. Keep in mind, the NIH study upon which their decision is based is only one of many Remdesivir studies currently going on, and they made their decision before all the data was even released. A recent study from China, published in The Lancet, showed no difference between Remdesivir and a placebo. Experts say the results from a single study, like the NIH study, are rarely game changers and safest approach is to pool data from several equally rigorous studies, which has not happened yet.

So, what are these benefits?

The only benefit that has been shared from the study, as of this posting, is that patients hospitalized with severe symptoms had a 31% faster recovery time than patients who received a placebo (11 days versus 15 days). There was a statistically negligible improvement in mortality.

Of course we'd all like to be sick for a shorter period of time when we are sick. But this drug does nothing to prevent us from catching Covid-19, and it does little to nothing to reduce our chances of dying from it. It does nothing to flatten the curve, reduce the infection rate or make the world a safer place. It does nothing to lower the risks associated with a premature return to work or relaxing social distancing policies.

And there are risks, though these get little mention in the press. For example, many patients dropped out of the Chinese study because of side effects and adverse reactions. The drug is toxic to both the liver and kidneys.

So, what's the real benefit? Why fast track its approval before all the data are in? Particularly when the drug is produced by a private company, Gilead, which expects to turn a handsome profit on the drug, meaning many people who need it won't even be able to get it?


  1. Big profits for Gilead and their investors
  2. A propaganda victory for Trump (See, we've got a drug to keep you safe. So, go to work. Go get your tattoos and massages.)
  3. Shorter recovery possibly means less time away from work, assuming the sick person had a job in the first place and still has one now
Once all the data are in, Remdesivir may, in fact, become a "game-changer" for sick patients, but the real game-changers will be drugs that cure people quickly and reduce mortality. Even better, how about a vaccine that is effective against the entire coronavirus family

While we don't know if the latter is even possible, the need is urgent. Epidemiologists have known for a while now that Coronaviruses and Influenza viruses were the most likely culprits in causing the next deadly pandemic. And they believe another deadly pandemic, like the current one, is likely.

One reason is that both virus families are spread easily through the air and remain viable on surfaces, making them easy to spread from person to person, even by strangers in public places, in contrast to Ebola and HIV, which require fairly intimate contact with sick individuals. Another reason is that both virus families reproduce by RNA, rather than DNA, and the enzymes used to replicate RNA make far more mistakes than the DNA enzymes, resulting in highly mutable viruses. Consequently, even if you gain immunity to one strain, either through illness or vaccination, you could still be susceptible to next year's strain. This is why we need to get a new flu vaccine each year.

A third problem is that there are already 50 new coronaviruses discovered in bats that have the potential to cause deadly pandemics in humans. Due to climate change and habitat destruction, humans are coming into contact with wild animals far more now than in the past, causing a rapid increase in zoonoses.

While we don't know which, if any, of these new coronaviruses will jump species and cause a pandemic, we certainly should be prepared. If SARS and MERS weren't sufficient warning, Covid-19 certainly is. A corona-family vaccine, effective against all coronaviruses, might be the best hope against a repeat of what we're going through now.

Whatever the final results of the NIH study show us, and regardless of how the emergency use authorization plays out for sick individuals, we still need to continue with social distancing, drug and vaccine research and development, rebuilding the health infrastructure to prepare for the next wave, produce sufficient PPE for frontline workers, and provide a much more effective and generous safety next for the millions of Americans who are struggling to survive.

Biased Science in the Service of Capital

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