The announcement on Monday, August 23rd by the US Food and Drug Administration that the Pfizer-BioNTech mRNA vaccine has received full approval should reduce concern and reluctance to receive this COVID vaccine.  The FDA decision was based on extensive review of both safety and efficacy over nine months and was subject to the same rigorous standards as applied to all other vaccines.  Previously EGG-NEWS countered concerns that the mRNA vaccines were developed too rapidly. EGG-NEWS posted an editorial last week explaining that mRNA vaccines have been the subject of extensive research and development extending over two decades.  Recent breakthroughs in molecular biology and bioengineering led to the simultaneous development of spike protein antigens and also nanolipid technology to introduce the antigen into receptor cells.  The development and testing of mRNA vaccines was stimulated by government funding that expedited availability within nine months from the onset of the pandemic.  Emergency use authorization of vaccines in December 2020 by the FDA was possible only by close cooperation among scientists at the National Institutes for Health-National Institute for Allergy and Infectious Diseases, Pfizer and BioNTech, the Department of Health and Human Services supported by its affiliate agencies and the military, providing logistics.

Awarding permanent approval to the Pfizer vaccine and hopefully the Moderna mRNA equivalent, will allow government agencies, educational and health organizations and commercial companies to mandate vaccination for employees. This is especially necessary in work situations requiring close contact that facilitates infection with SARS-CoV-2 virus by the aerogenous route. A number of unions have indicated that they would recommend vaccination to their membership and also agree to mandates under collective bargaining agreements once any COVID vaccine received full FDA approval.

It is encouraging that President Trump encouraged attendees at an Alabama rally on Saturday, August 21st to be vaccinated, confirming his own immunized status.  Regrettably there were some boos from the audience suggesting that anti-vaccination propaganda has deeply poisoned the well.

In recent weeks, opponents of COVID vaccine have erroneously misquoted data from Israel concerning breakthrough infection.  A frequently cited figure that 60 percent of all patients currently hospitalized for COVID were previously vaccinated is subject to interpretation.  Out of 515 hospitalized patients in Israel, 301 had received two doses of the Pfizer vaccine.  This figure is used to disparage the vaccine and to provide support for the notion that the vaccine is ineffective. This is simply not supported by the facts.

In a recent ProMED posting, Dr. Mary J. Marshall interpreted data and provided an explanation for the apparent anomaly.  Her article noted that nearly 80 percent of all residents of Israel over the age of 12 years have been vaccinated.  There is at present a disparity in age among vaccine recipients with 90 percent of residents over 50 years old having been immunized. In contrast the  majority of those unvaccinated are under 30 years of age. Dr. Marshall correctly noted that older people are more likely to suffer respiratory infections whether from COVID or other respiratory and systemic pathogens, proportional to age.  It is accepted that respiratory viruses are twenty times more likely to result in hospitalization in people over 50 years of age and 1,600 times more likely over the age of 90.

Dr. Marshall adjusted data by stratifying for age demonstrating that vaccines have retained efficacy in the range of 85 percent to 95 percent against severe disease, even with exposure to the Delta variant.  Data showed that even one dose of the Pfizer vaccine reduced hospitalization resulting from severe disease over a range of 75 to 85 percent.  It is emphasized that in evaluating data, crude counts are misleading. In the specific situation in Israel where the majority of hospitalized patients are advanced in years and many with comorbidities, the apparent high rate of hospitalizations following breakthrough infections is far lower than crude figures would suggest.  When the data from Israel was expressed per 100,000 people the rate for severe cases was 16.4 per 100,000 in unvaccinated individuals compared to 5.3 per 100,000 in fully vaccinated patients.  The threefold higher prevalence confirms that vaccination suppresses severe disease.  The efficacy data relating to vaccination may be interpreted as accepting that two thirds of serious infections leading to hospitalization would be among unvaccinated individuals.  A full analysis of Israeli data confirms that vaccine efficiency against severe disease for younger individuals is 91.8 percent and for those over 50 years of age, 85 percent.

Data from Israel corresponds closely to current trends in southern states with low levels of vaccination.  It is calculated that over 95 percent of those occupying ICU beds were not vaccinated and the demand for hospital care is increasing sharply in the states with low rates of vaccination and concurrent policies mitigating against masking and social distancing.

It is encouraging that for the three last working days of the previous week, U.S. vaccination rates increased to one million per day suggesting that concern over the delta variant and its clinical consequences have swayed the inhibitions of vaccine hesitant people.  Unfortunately, our health facilities and resources will be stressed by those who are completely opposed to vaccination.  These individuals are prolonging the epidemic and at the same time delaying restoration of our economy. The Kaiser Family Foundation determined that health care for non-vaccinated people cost the U.S $2.3 billion in June and July and the cost is expected to rise further in August.

Let us hope that the timely action by the FDA will encourage more extensive adoption of the Pfizer vaccine in states and communities with low rates of protection.  EGG-NEWS has always maintained that COVID is a public health issue and regrets the political overtones applied to the infection. Appropriate preventive measures including vaccination that most certainly keep people out of hospital will in the short term reduce institutional care and fatalities, now running at over 1,000 per day, and will avert the persistent clinical problems attributed to "long COVID".