SARS-CoV-2 vaccines on the horizon; what is America's response?

After almost 10 months of the SARS-CoV-2 pandemic there appears to be some light at the end of the tunnel. There are several SARS-CoV-2 vaccines on the horizon, with two approaching FDA approval. As at today December 6th 2020 there are 66,685,047 cases confirmed globally and 1.5 million deaths. In the US total cases count stands at 14,590,894 with 281,212 deaths. To put this in better perspective the current US death toll is at par with the whole city of Newark, NJ (population estimate 284,242 in 2020) being wiped out over the course of 10 months.

Since February a lot has happened in the area of science and technology. We have learned that use of high dose steroids saves lives in severe Covid-19 cases. The Regeneron and Lilly antibodies can possibly reduce likelihood of progression to severe disease if given early enough. Overall, physicians are better at selecting those more likely to have severe disease.

Just looking at numbers alone things may look better. Right about April 1st which was around the peak of what I would describe as our first wave the case fatality rate was 8.0%, by mid summer we were at 1.6% and currently my calculations put our case fatality rate at 1.2%. These calculations were mostly done using data from washingpost.com Covid-19 database. One assumption used in these calculations was that time from diagnosis to death for those who die is about 14 days.

Graph of US Covid-19 cases Adapted from the Washington Post

US Covid-19 cases showing peaks in diagnosis rates in Spring, Summer and the Fall – Winter peak which is yet to crest.

All these numbers and estimates fail to account for differences in testing rates and possibly improvements in the testing technologies over time. One thing that most would however agree upon is that we are definitely better at managing Covid-19. However as our current daily deaths are matching what we saw in the worst of April and May 2020 this early in winter, we are going to lose more cities if nothing happens by the summer of 2021.

I started this article by saying there appears to be light at the end of the tunnel. This is a light that not all are seeing as light. There are many who only see a lot of grey with this new era of our fight with Covid-19. In the past month two companies working on vaccines had press releases suggesting good phase 3 outcomes. Pfizer and Moderna reported data showing their Covid-19 vaccines are able to prevent infection in 90 -95% of those vaccinated. That is light at the end of the tunnel, and in my mind I am walking fast towards the light. In the United Kingdom (UK) the Pfizer vaccine has already been approved and the NHS is already planning to start vaccination this week.

Both companies, have submitted their data to the FDA for review. There are many who are asking why the FDA has not approved these vaccines at this time. Most of these calls are being made in relation to the situation in the UK. The National Health Service in UK will basically be rolling out its approved Pfizer vaccine this week. We must however give the USFDA its due, every regulatory agency has its own processes. The path from candidate drug to approval is very complex and we cannot expect the timelines to be similar.

Vaccine Implementation; Another Important Piece of The Puzzle

Beyond vaccine approval however there are many processes required for us to achieve control of Covid-19. One very important aspect of this is implementation of immunization programs. The Covid-19 vaccination campaign does pose a few unique challenges. Many have raised issues associated the stability of the RNA vaccines without an appropriate cold chain. Storage temperatures of -70 degrees Celsius required for the Pfizer vaccine may not be major problem for most industrialized countries. However even in the US there may still be concerns for some rural counties and Native American Tribal communities.

How many will take the Covid-19 vaccine

Among the 69 respondents in an online survey 46 (67.7%) will take the Covid-19 vaccine if offered

Over the past week I sent out a survey to friends and associates on WhatsApp as well as Facebook. I tried to avoid sending this to my healthcare worker groups. In the survey I wanted to query a broader population without oversampling doctors and other healthcare workers. In this survey, only 66.7% of those who responded were willing to take a Covid-19 vaccine if offered. Most of my respondents were people of African descent, 84% of my sample. I also looked at some open online surveys and the acceptance rates were similar, above 65% overall. I am still collecting data and will write a post specifically on that once I have 200 or more responses.

What Can Ordinary Americans do?

This is my advice to those who have concerns about Covid-19 or the vaccines developed to protect against SARS-CoV-2. The vaccines that have been submitted for FDA approval have gone through very rigorous testing. Both vaccines have each been tested in more 30,000 individuals. The speed in OWS (Operation Warp Speed) does not refer to the study processes. The speed was related mostly to financial risks associated with drug or vaccine development.

The companies involved which did not include Pfizer were given money by the US government. This allowed them to sidestep the stepwise nature of drug development. This allowed many processes to occur concurrently making things faster. The speed improved efficiency in the development process at the expense of cost not safety. The risks related to humans and drug safety remained unchanged.

Personally, I am waiting to be told there is a vaccine available for me to go and get my shot. Thus far as a country we have failed to control Covid-19 with simple public health measures, a vaccine may be our only saving grace. If we allow the false information of anti-vaccine groups to take hold our progress to a new normal would be delayed.

I believe many hate social distancing as much as I do. In this vein I would ask that we stop listening to those who will only look for the bad things about a vaccine. Be aware that many anti-vaccine groups may create false messages to push their agenda. Please get your message from your state or federal sources or from your trusted healthcare providers.