Covid-19 Vaccine On The Horizon



 





Covid-19 Vaccine On The Horizon

We had a lot of excitement when we heard about the invention of a vaccine for Covid-19. The world has been ravaged by coronavirus and the virus has taken more than 1.2 million human lives since March 2020. The pandemic has affected our livelihoods, social well being and now we live in a new normal way. We accept that the virus will not be extinct from the face of the earth and the only way to beat the virus is by inventing a vaccine, To achieve this,167 vaccine projects were set up globally, 72% of these projects were being led by pharmaceutical companies and the remaining 28% were managed by academics, public health and non profit organizations. The drug company Pfizer working together with German biotechnology company BioNTech has invented a vaccine for coronavirus which they claim to be 90% successful. For developing a vaccine for any micro organism, the developer has to go through different stages, and normally it can take over ten years to get it licensed. But in the case of Covid-19, Pfizer applied to get the approval fast through the Emergency Licensing Authorization (EUA) with Food and Drug Administration (FDA) of the US.

 

In order to invent the vaccine, the first hurdle was to study the structure of , the mRNA SARS-CoV-2 virus with spikes. Then the coronavirus was cultured in appropriate media. A very minute fraction of the spike protein of coronavirus is sufficient to make the vaccine. This is the exploratory stage in which through specialised techniques, antigen from the spike is taken. The collected material is injected in animals kept in the research laboratory. This is the preclinical stage in which the animal response and its effect on resisting the coronavirus infection are evaluated. If the vaccine is found suitable after the preclinical stage, the process has to go through clinical stage.There are four phases in the clinical development of the vaccine. During Phase one, small groups of healthy volunteers receive the trial vaccine. In this stage the response to the vaccine, changes in the physiological parameters, and general health of the volunteers are evaluated. In Phase two, the vaccine is given to people with biodiversity such as different age,sex, weight,race and physical health which match those for whom the new vaccine is intended. In Phase three, the vaccine was given to 43538 volunteers in a double blind study in which 50% were given the placebo vaccine and the other 50% the developed vaccine. In double blind studies those who receive the placebo injection will not be told the true nature of the injected material. For the completion of the Covid experiment, a second shot of booster vaccine was given after 28 days. The analysis confirmed 94 cases of Covid-19 infection in the 50% trial volunteers who had the real vaccine, but others were protected on exposure to coronavirus. First interim efficacy analysis was conducted on 08/11/2020 by an external independent Data Monitoring Committee (DMC) of phase three who announced the vaccine was 90% successful. Since then it has been confirmed that the vaccine is 95% successful and is effective in over 65 age group. At this stage, long term side effects or complications are not assessed. This will be done in phase four study after the approval, marketing and mass vaccination of the people. Phase four depends on the feedback from medical practitioners and healthcare workers who follow up the people who had the vaccine. Vaccine related side effects and complications can occur many months or years after taking the vaccine.

 

Currently Pfizer is awaiting regulatory approval of the vaccine by Food and Drug Administration (FDA) in US. In the UK, it is Medicines and Healthcare products Regulatory Agency (MHRA) which approve drugs and vaccines. The average cost to research and develop a drug is estimated to be £2.8 billion. For vaccines like covid-19 to be approved in a hurry, the cost can only be only guessed.To research and develop a vaccine, it takes an average of 10 years and just for clinical trials only it takes six years.It has been reported that the phase one and two of Pfizer Covid-19 vaccine development were done concomitantly, As discussed above for clinical trials phases two and three, in fact the time allocated is far too low. This means the recipients of trial vaccine were not monitored for all possible side effects and complications for at least one full year! This is because the whole world is in dire need to get a vaccine for coronavirus and to salvage the world from doomsday scenario. It has been reported that in the UK at least 25% of the population are not comfortable to take covid-19 vaccination. 


Centre for Biologic Evaluation and Research (CBER) of FDA is responsible for regulating vaccines in the United States.The developer of a new vaccine product follows a number of steps for the approval process. These steps are 1) An investigation on new drug application 2) Pre license vaccine clinical trials 3) A biologic licence application (BLA)  4) Inspection of the manufacturing facility 5) Presentation of the findings to FDA’s vaccine related biologic products advisory committee . 6) Usability testing of product labelling. It has been reported that to facilitate early mass vaccination programme, Pfizer has already instructed to manufacture Covid-19 vaccine in a commercial scale anticipating the vaccine will be approved by the regulatory body.

 

Once the Covid-19 vaccine of Pfizer is produced, it should be stored at minus 72 degree Celsius (-94F). This temperature is far too lower than an average medical freezer.Therefore the logistics of transportation and supply  are a mammoth task .The UK government plan to transport the supply by air from US, Germany and Belgium, deploy military personnel, and hire large halls to achieve mass vaccination. These batches of vaccine arrive at GP practices as dry ice vaccine. In the GP practice, it can be stored between 2-8 degree Celsius for seven days. and should be diluted prior to administering it to people. An average GP practice can give 90 vaccinations per day in view of the current social distancing restrictions. The Joint Committee on Vaccination and Immunisation (JCVI) have decided the priority of giving the vaccination. According to that healthcare workers and care home residents will be given first, then over eighties, followed by seventies, then over 65 years. JCVI has also decided that people under 50 who are at risk of contracting Covid-19  will be given priority. The vaccine has not been tested in children, and therefore children will not be vaccinated.  All those who receive the vaccine should have a booster dose after 28 days. Professor Ugur Sahin chief executive officer of BioNTech says there is in no need to have yearly vaccination even if the SARS-CoV-2 mutate, because the function of memory T cells will protect those who had the vaccination. He is also of the opinion that the effect of the vaccine in different age groups can only be derived through extrapolation. On a realistic note, he says by next winter (2021) we might be out of the clutches of Covid-19 pandemic.


As a medical practitioner I have given many different vaccines, to different age groups from infancy onwards, in different parts of the world. Except for pain at the site of the injection, there was no untoward side effects or complications.This is because, no live virulent, micro organism is injected into the body. As much as 25% of people are sceptical about receiving the Covid-19 vaccine. Sadly there is an anti vaccination campaign on social media against Covid-19 vaccination programme. Today (15/11/2020), the UK Culture secretary stated that the unregulated social media will be fined or prosecuted for aggravated failure to stop misinformation propaganda on Covid-19 vaccines. In this article I have not referred to the Oxford vaccine or other vaccines to be invented. The development, nature, storage and effect of Oxford and other vaccines might be different from that of Pfizer vaccine.

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