KAMPALA – I’m not a doctor, not a pharmacist, not a scientist and I must admit I was very poor at science subjects throughout my school time.
However, for what I have seen and heard, my common sense demands that I must add a voice to the covid 19 fears surrounding the vaccines.
For me, the behavior of some developed countries towards the use of certain covid 19 vaccines is an indicator of unhealthy competition and conspiracies by world class pharmaceutical companies pushing for mass vaccination against covid 19.
My writing is not going to dwell on the plight of Ugandans who have already received the covid 19 jab lest I’m crucified for giving misleading information.
Mine is the wider perspective of vaccines including those that have been allowed for use against covid 19. Uganda opted for the Astra Zeneca vaccine although other countries have rejected it for different reasons.
After all, it was our government that marketed the vaccine in the media and encouraged us to go for it. I hope they will own up to their decision should it be discovered that the vaccine was experimental and could have far reaching health hazards as compared to benefits.
When I watched some covid 19 movies which premiered over 7 years ago, I was left wondering if the so called first world countries did not know about the outbreak of the disease and prepared for it.
I’m pretty sure some if not all anticipated the outbreak of covid 19 and started preparing and testing their own remedies with the hope that they would use the outbreak as an opportunity to exploit the poor countries. When Americans came out to reject covid 19 vaccines recommended by the World Health Organisation it got many of us thinking about the safety of the vaccines and if they were outed and distributed prematurely.
We are even told that proof of vaccination from elsewhere will not guarantee visitors an automatic entry into America.
The Americans are in effect telling us that our vaccines are substandard and not adequate enough to guarantee safety. Just this week, there was a general outcry that these vaccines are causing many health problems than what had been anticipated by the World Health Organisation.
Fearing the worst and of course law suits, health experts have now began an investigation into verified complaints after covid 19 vaccination.
The Center for Disease Control (CDC) and Prevention advisory group was partly interested in reviewing rare cases of heart inflammation following use of the Pfizer and Moderna coronavirus vaccines in the developed countries. One of their major concerns is that a section of people vaccinated using their choice of drugs have reported symptoms like memory loss, loss of appetite, the inability to smell or taste while some have reported cases of erectile disorders, chest pain or had an unknown status after vaccination.
The CDC said that most reported cases occurred in males age 16 and older and typically within several days of receiving the second vaccine dose, though some reports came after the first dose. Sadly, the agenda of the emergency meeting by the CDC’s Advisory Committee on Immunization Practices includes a discussion of the condition but was devoid of any scheduled vote for changing recommendations for the use of the vaccines.
The AstraZeneca vaccine was initially developed as a single-dose vaccine, estimated to have an efficacy of about 70+ against disease in clinical trials. These trials were later amended to include a second dose when other work showed two doses significantly increased antibody levels.
We ought to be reminded that the outbreak of corona virus was first reported from Wuhan, China, on 31 December 2019. Uganda reported its first case of COVID-19 on March 21, 2020 before cases surged leading to a lock down in the same month. In other words, from the time the disease broke out to the time the vaccines were prepared and disseminated for use, it was hardly one year down the road. Could this have been sufficient time to allow the testing of the vaccines to determine their efficiency, side effects and safety?
Reading through a journal by the U.S Department of Health and Human Services on Vaccine product approval process, I was astonished to learn that Vaccine Development and Testing is a complex process that takes about 10 years or more and involves a combined effort of public and private involvement.
The current system for developing, testing, and regulating vaccines developed during the 20th century as the groups involved standardized their procedures and regulations. At the end of the 19th century, several vaccines for humans had been developed. They were smallpox, rabies, plague, cholera, and typhoid vaccines. However, no regulation of vaccine production existed.
On July 1, 1902, the U.S. Congress passed “An act to regulate the sale of viruses, serums, toxins, and analogous products,” later referred to as the Biologics Control Act (even though “biologics” appears nowhere in the law). This was the first modern federal legislation to control the quality of drugs. This act emerged in part as a response to 1901 contamination events in St. Louis and Camden involving smallpox vaccine and diphtheria antitoxin.
The Act created the Hygienic Laboratory of the U.S. Public Health Service to oversee manufacture of biological drugs. The Hygienic Laboratory eventually became the National Institutes of Health. The Act established the government’s right to control the establishments where vaccines were made.
The United States Public Service Act of 1944 mandated that the federal Government issues licenses for biological products, including vaccines. After a poliovirus vaccine accident in 1954 (known as the Cutter incident), the Division of Biologics Standards was formed to oversee vaccine safety and regulation. Later, the DBS was renamed the Bureau of Biologics, and it became part of the Food and Drug Administration. It later evolved into the Center for Biologics Evaluation and Research.
In the European Union, the European Medicines Agency supervises regulation of vaccines and other drugs. A committee of the World Health Organization makes recommendations for biological products used internationally. Many countries have adopted the WHO standards. In the United States, vaccine development and testing follow a standard set of steps. The first stages are exploratory in nature. Regulation and oversight increase as the candidate vaccine makes its way through the process.
Vaccines are developed, tested, and regulated in a very similar manner to other drugs. In general, vaccines are even more thoroughly tested than non-vaccine drugs because the number of human subjects in vaccine clinical trials is usually greater but occasionally, the process can be expedited if there is an urgent need like during a pandemic such as corona virus. Most vaccines have been in use for decades, with millions of people receiving them safely every year. As with all medicines, every vaccine must go through extensive and rigorous testing to ensure it is safe before it can be introduced in a country’s vaccine programme.
Each vaccine under development must first undergo screenings and evaluations to determine which antigen should be used to invoke an immune response. This preclinical phase is done without testing on humans. An experimental vaccine is first tested in animals to evaluate its safety and potential to prevent disease. In all this, we need to be reminded that vaccines are designed to stay in the body for life and thus there is no room for making mistakes.
If the vaccine triggers an immune response, it is then tested in human clinical trials in three phases. During phase two and phase three trials, the volunteers and the scientists conducting the study are shielded from knowing which volunteers had received the vaccine being tested or the comparator product. This is called “blinding” and is necessary to ensure that neither the volunteers nor the scientists are influenced in their assessment of safety or effectiveness by knowing who got which product. After the trial is over and all the results are finalized, the parties involved are informed who received the vaccine and who received the comparator.
When the results of all these clinical trials are available, a series of steps is required, including reviews of efficacy and safety for regulatory and public health policy approvals. Scientists in each country closely review the study data and decide whether or not to authorize the vaccine for use for a given diseases. A vaccine must be proven to be safe and effective across a broad population before it will be approved and introduced into a national immunization programme. The bar for vaccine safety and efficacy is extremely high, recognizing that vaccines are given to people who are otherwise healthy and specifically free from the illness.
Further monitoring takes place in an ongoing way after the vaccine is introduced. There are systems to monitor the safety and effectiveness of all vaccines. This enables scientists to keep track of vaccine impact and safety even as they are used in a large number of people, over a long time frame. These data are used to adjust the policies for vaccine use to optimize their impact, and they also allow the vaccine to be safely tracked throughout its use. Once a vaccine is in use, it must be continuously monitored to make sure it continues to be safe.
Roger Wadada Musaalo is a Lawyer, human rights activist, researcher, and politician
