Life in the Vaccine World, 4/26/21

Well, it’s now been over a year since the US went into it’s first set of shelter in place/stay at home orders at the beginning of the Covid-19 Pandemic. And while there is hope moving forward, there is still a lot of unknown and I’ve received a lot of questions about what this new ‘reality’ means. Specifically about what it means to be vaccinated both now and in the future and what risk does the virus and vaccine pose to those who are still unvaccinated? Note that unlike some of my previous posts this one will contain a lot of opinion and speculation, as it’s dealing with unknown topics. I will try to be clear of when I’m giving my thoughts vs providing evidence from research and data as always, and if you disagree that’s perfectly fine (All I ask is you use evidence to support your claims).

First off, the discussion about the vaccines. Currently in the US there are three vaccines that have been given Emergency Use Authorization, meaning they have been approved for distribution in a regulated manner, pending constant review of safety and efficacy data. As with all medicines, if any issues or uncertainty arise the FDA has the authority to modify their status and reassess the situation. So far the Moderna and Pfizer vaccines have had no major issues with vaccination (that have warranted a pause), just the usual side effects that recipients experience (sore arm, fatigue, headaches, fever, etc). For the Johnson and Johnson and AstraZeneca (not given EUA) adenovirus vaccines this is a different story. As of this writing on 4/23/21 both of these vaccines are being investigated for rare adverse event blood clots (US FDA, see link below). These rare blood clots have occurred both in the US and Europe and at the time of this writing one hypothesis is, in rare cases autoantibodies are created causing platelet aggregation and a medical issue known as Cerebral venous sinus thrombosis. The Johnson and Johnson vaccine has been released from it’s temporary hold in the US (as of 4/23/21), after a thorough review of the cases and data by the FDA and CDC, and is again being distributed. This is sign of the system working, when ANY issue arose the vaccine was paused and investigated, the risk was found to be extremely low and medical providers have been notified how to identify and treat the rare cases of clotting (Yale Medicine 2021). Note that the rare cases of blood clots in the US have occurred in 8 out of nearly 6.8million J&J vaccinated people in the US (I received my J&J on 3/22), making them very very rare (0.00012% of those receiving the vaccine). In fact, the frequency of these cases of vaccine induced blood clots is approximately 10x lower than occurs with natural Covid-19 disease (Taquet et al 2021) and is also a rare adverse event for many other widely utilized medications (like contraceptives, Aleve, Ibuprofen and Viagra), meaning while it’s something to be aware of, it’s not unusual for medicines. So while the vaccine is far safer and less risky than natural Covid-19 disease, for women between the ages of 16-50yo (primary affected group) it’s something to consider and one may opt to receive the Pfizer or Moderna vaccinations instead while these events are being further reviewed and understood. An additional note, that while the blood clots can be life threatening, if the signs/symptoms are identified they are treatable, so if you receive the J&J vaccine keep an eye out for severe headaches, severe abdominal pain, shortness of breath within 6-14days of your vaccination.


With that out of the way, I now wanted to dive into the topic of “I’m vaccinated, now what does that mean for our lives?” From an efficacy standpoint, once you are two weeks out from receiving your vaccination(s) you are much less likely to become infected, but this does not mean it’s impossible. The CDC recently released the first set of data discussing the breakthrough cases, these are cases of Covid-19 in previously vaccinated individuals. The case count as of 4/20/21 was 7,157 individuals over the 4months of vaccination (over 100million people vaccinated) with 498(7%) cases of hospitalization and 88(1%) deaths (CDC Stats). While this is unfortunate, it was NOT unexpected as the vaccines were shown to be 70-95% effective at REDUCING infection in the clinical trials, meaning sadly not everyone is fully immune from potential infections. This is due to insufficient immune building or receiving a viral inoculum that overwhelms the immune system (happy to answer direct PMs about this complicated topic). The good thing is, 7,157 breakthrough cases in the US is actually a fairly small number when you consider that in the month of April >1.2million new people have become infected already and >14,000 people died this month (CDC Covid Data Tracker), so again, the vaccinate have a GREATLY reduces the chance of becoming infected.

Now on to a much more complicated topic, what a vaccine means for our daily lives, interactions and opening up society. First off, a lot of this decision will be based on an individuals risk tolerance and personal decision making, as such I’m going to do my best to refrain from telling you what you should or shouldn’t do, and instead provide each individual things to consider while they go through their daily lives. I’ll first go into what it means to be vaccinated, then speculate on how some of the new mutations might affect the future.

As discussed above, once you are fully vaccinated your risk of becoming infected dramatically drops. Meaning, you are far less likely to both carry the virus and to become infected (CDC MMWR 4/2/21). The converse of this is there is a small possibility that a vaccinated individual becomes infected (especially from an unvaccinated person) and can spread the virus. Now this doesn’t mean you have to keep yourself shut inside forever, but it does mean there is still a low level of risk out there. Situations that would pose the highest risk are any that put you in contact with large numbers of people, indoors in close proximity (yes bars and restaurants), unmasked for extended durations. Thus there are plenty of things that create much less risk in your life but still allow you to connect with others and socialize. Just consider who and how long you’re interacting with people, hopefully from known social circles. So just remember, each person you interact with and are in close contact with, whether you know them or not, becomes part of your social circle, and connects to others in your social circle (think of a giant spiderweb). Based on my personal risk tolerance I won’t be going to any bars, clubs, indoor concerts and will be minimizing indoor restaurant dining for now.

As of this writing the strains discovered in Italy 2020 and UK 2020 are the predominant strains circulating in the US, but there are newer strains discovered in South Africa, Brazil and India containing mutations that reduce the vaccines effectiveness (note they DO NOT render vaccines ineffective). Even with that, the vaccines appear to reduce severity and symptoms of the new viral strains, thus offering some protection. No one can predict the exact future, but here are a few things to watch for as the pandemic moves forward. While the virus still spreads at an uncontrolled rate worldwide, mutations will continue to accumulate, many unproductive, though some will lead to changes that are beneficial for the virus. As such I expect there to be a new vaccine booster shot that becomes available in 2021/2022 to address some of these changes, scientist from Moderna are already testing one of these (NIH 2021). So while it is fantastic news that the US is nearing half the population having received at least 1 shot, until we can vaccinate a large proportion of the world this virus will continue to spread and mutate. Locally, vaccines will dramatically slow the spread, reduce the hospital burden and save tens of thousands (or maybe hundreds of thousands) of lives but vaccinating the US alone won’t bring things fully back to normal. Since SARS-CoV-2 has a proof-reading enzyme the virus doesn’t mutate as fast as others (thankfully), so once the viral spread no longer becomes globally uncontrolled the mutations will slow and eventually cease. Again, this is just a hypothesis, but is one of the long-term goals of the global pandemic response. Combined with the potential of discovering additional live saving therapeutics, these are the tools that will help us move into a healthier future. Again, this last paragraph is all speculation and there are innumerable factors that could easily swing us off this trajectory or dramatically change the course of the pandemic response. No one knows the future, all we can do as Scientists and society as a whole is be aware of the most likely future directions and plan as best we can to deal with those challenges.

References:
CDC Stats. COVID-19 Breakthrough Case Investigations and Reporting. 4/20/21. https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html
CDC Covid Data Tracker. 4/23/21. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases
CDC MMWR 4/2/21. Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers. CDC MMWR 4/2/21. 70(13):495-500.
FDA. FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review. https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough
NIH. NIH clinical trial evaluating Moderna COVID-19 variant vaccine begins. 3/31/21, https://www.nih.gov/news-events/news-releases/nih-clinical-trial-evaluating-moderna-covid-19-variant-vaccine-begins
Taquet M et al. Cerebral venous thrombosis: a retrospective cohort study of 513,284 confirmed COVID-19 cases and a comparison with 489,871 people receiving a COVID-19 mRNA vaccine. Oxford University, 2021.
Yale Medicine. The Johnson & Johnson Vaccine and Blood Clots: What You Need to Know. 4/23/21. https://www.yalemedicine.org/news/the-covid-vaccine-blood-clots

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