why trust the covid-19, coronavirus, vaccines despite being made in record time

Vaccines are likely the greatest miracle in the history of modern medicine. Vaccines played a major role in significantly increasing the life expectancy of mankind over the last few decades. Traditionally, it has taken years to develop an effective vaccine that also has a good safety profile. Today, the crisis surrounding the COVID-19 pandemic created an urgency to speed up our vaccine development initiatives. Obviously, this record-speed achievement raised a lot of skepticism around how this was done, and whether these vaccines are safe to administer. This article attempts to explain why indeed it was possible to make these vaccines in record time without compromising safety and efficacy.

There are several good reasons why it took a short time to make the vaccines — no corners have been cut!
New mRNA technology of the Pfizer/BioNTech’s and Moderna’s COVID-19 vaccines bypassed a time-consuming requirement of isolating and growing the coronavirus
For the mRNA vaccines, there was no need to grow or isolate a virus in order to make the vaccines. Instead, these vaccines used a new technology that only requires the genetic instructions on how to make a tiny piece of the virus when injected into our body.
The highest priority was set and loads of money were being pumped towards the development of the vaccines
If you allocate an almost unlimited amount of funding, backed by a significant proportion of the world’s researchers, clinicians, regulatory bodies, and other critical infrastructure towards a single endeavor, extraordinary things can be achieved in record time. It is true that vaccines have taken years, more than a decade even, to develop in the past, but most of that time was often spent raising the money for trials to run, negotiating contracts with study sites, recruiting large numbers of human volunteers to participate in the study, and applying for regulatory approval. Although, our record for developing a new vaccine was about four years previously for the mumps vaccine.
Recruiting thousands of volunteers went much faster
Historic vaccine trials rarely took place during a pandemic crisis like this one. Fortunately, we had thousands of people, including our frontline healthcare heroes, who were keen on participating in clinical studies. Kudos to those unsung heroes!!
Various steps in the vaccine development path were happening concurrently rather than sequentially
These vaccines have been developed quickly as a result of safety trials, efficacy trials, manufacturing, and distribution planning occurring concurrently rather than sequentially as they have historically. None of the steps were skipped — instead, they were done simultaneously and completed in a satisfactory manner per regulatory mandate.
Luckily, vaccine developers had a head start on the first phase of vaccine development, which is academic research. In the past, the outbreaks of SARS and MERS, which are also caused by coronaviruses, prompted lots of research and gave us valuable knowledge. SARS and SARS-CoV-2 (the virus that causes COVID-19) are ~80% identical, and both use spike proteins to grab onto binding partner proteins found on cells in our lungs. This also helps explain how we developed a test for Covid-19 rather quickly. Typically, academic research and preclinical animal testing can take years (up to even 4 years). Repurposing knowledge from SARS and MERS research for COVID-19 allowed scientists to bypass these years by not having to start from scratch. We were able to instead do a very quick preclinical animal study that pretty much overlapped with phase 1/2 (safety/dosing) studies, which overlapped with Phase 3 (efficacy) studies. Of course, there is a high price tag to moving at this lightning speed, but funding was not an issue in this case.
Other than massive funding, Pfizer's and Moderna's compressed timeline reflects unique partnerships between industry, government, and academia, and decades of previous research on mRNA vaccines. For instance, mRNA vaccines showed potent immunity in animal studies with influenza virus, Zika virus, rabies virus, and others. Also, mRNA cancer vaccines have been employed in numerous human cancer clinical trials, with some promising results showing stimulation of immune responses and prolonged cancer-free survival.
All parties involved in the COVID-19 initiative worked round the clock given the nature of the crisis. Both companies (Pfizer and Moderna) followed the requisite progression from Phase 1 to Phase 3 trials with careful study design and rigor.
A faster timeline does not mean that safety steps are skipped
As mentioned above, some phases of the clinical study were conducted simultaneously. The preclinical phase was done in conjunction with phase 1 rather than sequentially as they are typically done. This approach was justified because there were some existing data from other phase 1 and preclinical studies that showed that these vaccine platforms themselves were safe.
Two federal advisory boards (the FDA and the US Centers for Disease Control and Prevention) along with a separate advisory board in New York have evaluated Pfizer's results and approved the vaccine through the Emergency Use Authorization process. The same process was employed for the Moderna vaccine.
Pfizer's large study results have also undergone external peer review and are published in the prestigious New England Journal of Medicine. The goal of each of these independent review teams is to scrutinize the data inside and out to identify problems before giving the green light. It is highly unlikely that all of them overlooked a problem related to safety and efficacy.

How Vaccine Makers Were Able to Make mRNA COVID-19 Vaccines in Record Time

Modified and annotated by Vaxtherapy.com  Original source: https://www.nytimes.com/interactive/2020/04/30/opinion/coronavirus-covid-vaccine.html — Modified and annotated by Vaxtherapy.com
*Original source: https://www.nytimes.com/interactive/2020/04/30/opinion/coronavirus-covid-vaccine.html*

2. Clinical studies are overseen by third-party, independent experts to remove any biases

Clinical studies are overseen by a third-party, independent panel of data safety monitoring experts, particularly scrutinizing whether any adverse safety events are directly related to the vaccines. If so, they are there to stop the studies and investigate the matter closely.

3. mRNAs and the proteins made from the instructions coded in the mRNA do not cause any disease

Once injected, the mRNA is degraded after a few days by the body, leaving behind only immunity to COVID-19. Since the mRNA is broken down by our body, it is physically impossible for it to be incorporated into our underlying genetic material (ie, DNA) and cause any harm.

4. Consistency gives confidence: two mRNA vaccines demonstrated similar success rates with no serious safety concerns

Consistency of results in science is key. The fact that the two mRNA vaccines showed similar success rates of ~95% protection against symptomatic Covid-19 is reassuring. Each of these studies was conducted independently on slightly different study populations, but both came to the same conclusions.

5. Even high-risk individuals with weaker immune system did well in the COVID-19 vaccine trials

People with weaker immune system, such as those living with HIV, were included in the trials. No safety concerns were observed in this high-risk population. Clinicians also say that there is no potential for people with autoimmune disease to increase their autoimmune disorders over the long-term; if anything, getting infected with SARS-CoV-2 can cause massive interferon (inflammatory protein) release, which should be more concerning for people with autoimmune disease.

6. More than 70,000 volunteers in both mRNA Vaccine trials showed no serious safety concerns

To obtain the seal of approval from the FDA and the Medicines and Healthcare products Regulatory Agency, they make sure that the drugs are safe. The vaccine, developed by either Moderna or Pfizer and BioNTech, has been through three phases of clinical trials and was administered to more than 70,000 trial participants with no serious safety concern.

7. Side effects are real but minor, and certainly not nearly as bad as COVID-19 itself

The vaccines will cause temporary, but minor side effects, such as low-grade fevers, muscle aches and fatigue, and headaches--especially after the second dose. However, these side effects are neither life-threatening nor long-lasting. The worst possible reaction is anaphylactic allergic reactions, which are rare and treatable.

8. Historically, long-term side effects were extremely rare, which weren’t detected until after the people were widely vaccinated

Long-term side effects are extremely rare (1 in 500,000 or even a million). Long-term side effects aren’t typically detected during the clinical trial; they aren’t detected until after the vaccines are widely distributed.

In the COVID-19 trials, most side effects showed up within days, or at most a few weeks, while the trial participants were monitored for two months or longer. The Pfizer and Moderna mRNA vaccines are deemed safe by the regulatory bodies. The likelihood of short and long-term harm from COVID -19 far outweighs the potential risks from the vaccines.

9. Various types of mRNA vaccines have been investigated in clinical trials for more than a decade, providing us with safety and tolerability assurance from other studies

There is a lot of hesitance about the uptake of “mRNA” vaccines since they are new, and people are under the impression that there aren’t any long-term safety data to rely upon. As a matter of fact, there are a whole bunch of clinical trials that have been completed evaluating various types of mRNA vaccines in different infectious diseases. Here is a list of a handful of completed mRNA vaccine trials that provides us with a few years of good safety and tolerability data (some publications are linked below):

HIV-1 mRNA vaccine by Argos Therapeutics
- Phase 1 (trial number: NCT02042248) completed (duration: from 2014 to 2017)
- Phase 2 (trial number: NCT01069809) completed (duration: from 2010 to 2017)
- Phase 2 (trial number: NCT00672191) completed (duration: from 2008 to 2013)

HIV-1 mRNA vaccine by Massachusetts General Hospital
- Phase 2 (trial number: NCT00833781) completed (duration: from 2009 to 2016)
HIV-1 mRNA vaccine by McGill University Health Centre
- Phase 1/2 (trial number: NCT00381212) completed (duration: from 2006 to 2009)
Rabies virus mRNA vaccine by CureVac AG
- Phase 1 (trial number: NCT02241135) completed (duration: from 2014 to 2018)
Influenza virus mRNA vaccine by Moderna Therapeutics
- Phase 1 (trial number: NCT03076385) completed (duration: from 2017 to 2018)
Zika virus mRNA vaccine by Moderna Therapeutics
- Phase 1/2 (trial number: NCT03014089) completed (duration: from 2017 to 2019)

Disclaimer: Vaxtherapy is NOT affiliated with any of the pharma/biotech companies working on COVID-19 vaccines. The purpose of this post is to provide education and awareness from a virologist’s independent perspective based on available facts and data.

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Why Trust the COVID-19 (Coronavirus) Vaccines Despite Being Made in Record Time?

There are several good reasons why it took a short time to make the vaccines — no corners have been cut!