By Dr. Ernst von Schwarz, Cardiologist, Medical Researcher drvonschwarz.com
Finally, we as healthcare providers will have an option to help end the COVID-19 pandemic. New vaccines will hopefully create herd immunity and eradicate this deadly disease. Over the last several weeks news reports have focused on 2 vaccines, one of which was co-developed by the German company BioNTech and the US pharmaceutical giant Pfizer. The second vaccine was developed by Moderna, a relatively small biotech company, in collaboration with the National Institutes of Health. The Pfizer vaccine showed a 90% effectiveness in preventing mild and severe forms of COVID-19 in individuals who were vaccinated. A total of more than 44,000 volunteers were part of this study which resulted in a total of 170 COVID positive cases in which 162 of those were in the placebo controlled group and only 8 in the vaccinated volunteer group. At the same time the company Moderna reported a 94.5% effectiveness in their vaccine product which prompted Pfizer to reissue a statement a day later, showing a 95% effectiveness rate. Obviously, both vaccines seem to be highly effective when given to these volunteers.
Pfizer receives COVID-19 vaccine emergency use authorization approval by the FDA. Pfizer and Moderna have applied for emergency use authorizations for their COVID-19 vaccines by the US Food and Drug Administration (FDA), with Pfizer becoming the first to gain approval. The first doses are now being distributed and ii is estimated that wide spread distribution will be available in spring 2021. Pfizer stated that by the end of 2020, 15 million doses will be manufactured and half of those are planned to go to the United States. Both the Pfizer and Moderna vaccines, reuire two dose applications as subcutaneous injections; for the Pfizer vaccine 3 weeks apart from each other, for the Moderna vaccine 4 weeks apart. The vaccines must be stored in ice. For the Pfizer product it is actually required to be stored in a freezer at -95 degrees which can be kept for 5 days. The Moderna product can be kept in the refrigerator at -4 degrees for up to 30 days. Side effects for both products as far as we know at this point are very mild; fatigue occurred in 3.7% and headaches were reported. No serious side effects were reported by either product.
A novel vaccination technique developed in record time The amazing thing to know about these vaccines is first the speed, meaning how quickly those vaccines were developed by these companies. Secondly, the use of a completely novel technique of using a synthetic version of the coronavirus genetic material in the form of MRNA (messenger ribonucleic amino acids) which induces in the recipient the production of “spike” or surface proteins of the coronavirus which then in turn will result in an immune response including T-helper cells, killers cells and the production of antibodies which then in combination will attack if the individual is exposed to the real virus.
This new technique has never been used for any vaccine development and does not require the real virus material to be injected into the individuals but instead a synthetic version of its genetic material is used. Through this method a much higher immune response is expected with a higher effectiveness and efficacy when the individual is exposed to the coronavirus.
Under usual circumstances it takes several years to develop a vaccine, from the initial development in the laboratory to cell testing, animal testing, then safety testing in a small number of individuals followed by large number of individuals and then a clinical trial. However, in the current situation of the COVID-19 pandemic it was crucial to act quickly. The biotechnology and pharmaceutical companies put major effort into this worldwide task to speed up their processes and did an amazing job to come to this point within less than 9 months. We now have a vaccine available.
The next steps after the vaccine’s FDA emergency use approval are placing priorities for use, and everybody agreed that the first use should be for those considered at highest risk for contracting the virus. These groups include frontline workers such as healthcare workers (nurses, physicians, in intensive care units and emergency rooms), residents in senior citizen establishments, the elderly, and also those with underlying severe pulmonary and heart conditions. This distribution and subsequent vaccination began December 14, 2020 and twide spread distribution, requiring millions of doses to be manufactured, should be available by early spring of 2021.
Of interest, the vaccine will be free for all consumers since the US government bought a large majority of the doses and will cover the costs. Of course there are still some unanswered questions such as the real world effectiveness outside of the frame of clinical studies, potential unforeseen and even long-term side effects, and whether or not someone who contracted the virus after vaccination still might be able to spread it to others or not. At the same time there are many other companies working on vaccine development and currently there are more than 80 clinical studies ongoing to assess the safety and effectiveness of different vaccine products.
As we hear in the media, there are several conspiracy theories circulating against the vaccine which play on the understandable fear of many consumers of getting vaccinnated with a completely new drug agent which has not been around for a long time, such as influenza or smallpox vaccines.. As healthcare providers however, we eagerly await getting our hands on the vaccines, especially in view of the current surge of COVID-19 infections, with more than 3000,000 deaths so far in the United States alone, and more than 10 million infections with further increases to be expected during the winter months, especially because of weakened immune systems, concomitant respiratory infections, and the flu season.
Until the vaccine or many of them are widely available, usable, and hopefully eradicate COVID-19 disease we still encourage the public to continue measures such as wearing masks, keeping social distance of 6 feet, avoiding gatherings, frequent hand washing, and following the CDC guidelines with regard to isolation of people infected with COVID-19 and quarantine for people exposed to infected individuals.