COVID-19 Vaccine

 

OK listen up: there will NOT be a vaccine this year. I said this in the spring and many other times and I am reiterating it again now.

So why am I writing about it? Because people keep asking me about it. Please understand that discussions about vaccines are diversionary tactics and you need to keep your eye on the ball.

We have heard we would have a vaccine by the end of summer, now its October. We even have a military style term for producing the vaccine: "Operation Warped Speed". Come on people, does that really sound like a scientifically sound project or just a good media sound bite? I have to admit it’s a little catchy but catchy doesn’t cut it when you are dealing with people’s lives.

Having a master’s degree in public health (from Harvard) and having studied preventive medicine (at Johns Hopkins) I think I understand a little something about vaccine trials and how they work.

Here’s some information about what “some vaccines are now in phase three testing” really means and why we cannot bank on “herd immunity” anytime soon.

In the US we are long way from herd immunity, this is what happens when enough of a population has developed immunity that spread of a disease in a community becomes unlikely. Herd immunity can happen in two ways: through infection and through vaccination. The herd-immunity threshold is thought to be somewhere around 43% to 66% of the population for corona viruses.

Which would require that we further infect about six times more people than those who have already contracted COVID-19 in this country. If this happened tens of thousands more people would die and the health care system would be pushed to its limits and beyond.

So what’s the deal with a vaccine?.

Think of a vaccine as forcing a practice session on the immune system. Vaccines give the body a sneak peek at one or more key features of a virus before the actual virus invades. The immune system creates a “memory” of the virus and is better able to fight it off.

Operation Warped Speed is being funded by the American tax payer which is one of the reasons the vaccine trials are faster than is normal for a regular vaccine. Why? Well first of all the companies that develop vaccines have to evaluate all along the way whether it is cost effective to continue with the process since they don’t want to end up in the red with a vaccine that doesn’t work. In the case of Covid-19 they don’t have this restraint because the federal government is footing the bill. Nothing like money to make people move at warped speed !

There are multiple different kinds of vaccines that are being tested. For example, one might take a portion of the virus such as the spike (the projections from the virus that give it a crown look, hence the name corona) to see if it can generate a protective response without actually giving you the disease or make you sick in other ways. One may take the antibodies formed by someone who has had the disease and synthetically copy them many times over and see if that helps. One is to take the actual virus and divide it so many times that it becomes so weak it can still generate a response but not cause disease. And so on. They are all different and the race is on to figure out which ones work.

Clinical trials test drugs or medical devices on human beings. To get that far, a vaccine has already shown promise in the laboratory and in animal studies. Once a vaccine is ready for testing in human volunteers, the U.S Food and Drug Administration (FDA) requires success through three trial phases before approval for widespread use.

A phase 1 trial tests the vaccine’s safety with tens of patients. A phase 2 trial tests the vaccine’s safety as well as its effectiveness at different doses with hundreds of patients. A Phase 3 trial tests the vaccine’s safety and effectiveness with thousands of patients. The first vaccines being tested in the U.S. will include 30,000 participants each, and the trials will follow them for two years. One of the challenges is that there is a federal requirement that there should be all races included in the vaccine trials.

Most of the vaccine developers had hoped for at least 50% of black, indigenous and latinx participation in the trials to comply with the mandate to include minorities. So far none of the trials have managed to get more than 27% of minorities. According to the FDA, the least willing to participate are African Americans. So now the vaccine production companies have started recruiting at historically black colleges and universities (which are more trusted institutions for many Black Americans). 

But everything from supplying syringes to managing storage facilities will add to the challenge of the greatest mass-inoculation campaign the world has ever seen.

These trials are randomized, double-blind, placebo-controlled trials. That means that some of the participants get the vaccine and others get a placebo injection of salt water. Who gets the drug or the placebo is random and neither the participant nor the health care workers doing the injections will know who gets what. Even the researchers leading the trials will not know who got the vaccine or the saline injection. That’s why the trial is known as “double blind”.

More than half of those receiving early COVID-19 vaccines reported mild, short-term side effects such as fever, headaches, muscle aches, and injection-site reactions.

The first vaccines to be tested in the U.S. have required a booster about a month after the first injection. So the vaccine or vaccines will probably require a booster shot. But there should be a gradual buildup of immunity during the post-vaccination window.

After the phase 3 trials have been successful then the FDA has to approve the vaccine before it can be released to the general public and not everyone will get it at the same time.

The bottom line is that even at warped speed somethings can be speeded up, but nature cannot. For sure a vaccine cannot accommodate an election agenda no matter how many times we say it can.

Every coronavirus death is an avoidable tragedy which has been the case from the beginning of the pandemic. The way forward is to socially distance, clear the air, wash hands, and mask up until a vaccine opens up a controlled, safe road to herd immunity. In the meantime don’t hold your breath. There will NOT be a vaccine for you this year!

I am totally open to feedback. Be safe!