Approval of COVID19 vaccines, safety concerns - By Dr Edward Nazareth




 

 

 

 

 

 

 

 

 

 

 

 


By Dr Edward Nazareth

Jan 6: Finally we in India will be getting the vaccines against COVID 19 virus soon. The Drug Controller General of India (DCGI), the India’s national drug regulator, gave emergency approval to use COVID 19 vaccines manufactured in India by Serum Institute of India and Bharat Biotech.


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The approval is ‘on an emergency basis’ and ‘for restricted use’ in the country.

Emergency use authorization (EUA)

In most of the countries, all medical products-medicines, vaccines, diagnostic tests, medical devices and all such materials related to be used on humans require the approval of a regulatory authority before they can be used. In India, the regulatory authority is the ‘Central Drugs Standard Control Organisation (CDSCO)’.

For medicines and vaccines the approval is granted after the assessment of their safety and effectiveness. This is based on data from clinical trials. The trials are done in different stages and the approval is required at every stage of the trials. Naturally this takes a long time. Approval is not given unless the authorities are convinced that the product is absolutely safe and effective. In emergency situations, like the current one, regulatory authorities grant interim approvals if there is ‘sufficient evidence’ that the medical product is safe and urgently required.

In the US, the Food and Drug Administration (FDA) grants ‘emergency use authorization’ only after it is satisfied that the ‘known benefits outweigh the known risks of the vaccine’. This is done only after efficacy data from the final trials were submitted. The EUA is not given based on earlier results of the trial; even if they show that the vaccine is safe.

The experts are of the opinion that India’s drug regulations do not have provisions for ‘emergency use authorization’, and the process is not clearly defined or consistent. Despite this, two vaccines are given ‘emergency use authorization’ simultaneously. Of these the vaccine manufactured by Serum Institute of India ‘Covishield’ had published its data and is known to be relatively safe. Whereas the trial reports of ‘Covaxin’ the vaccine manufactured by Hyderabad based Bharat Biotech is not yet available. The company’s managing director Krishna Ella had assured after the approval that the company’s vaccine was safe and the company was conducting trials in more than 12 countries apart from India. The final data will be available probably by two or three months from now. Many of the experts have expressed concern over the approval given to ‘Covaxin’. Only approval to ‘Covishield’ was expected, and the approval to ‘Covaxin’ is a mystery.

In the United States and United Kingdom, the first doses of the vaccine were administered within a day or two of the approval of Pfizer-BioNTech and Moderna vaccines. In India too, the process is likely to start soon. While no concrete timelines are known now, it can be reasonably expected that the mass vaccination programme will begin within a week.

Difference between Covishield and Covaxin

Though these vaccines are against a single virus-COVID19, the vaccines are not the same. The people who need protection against the infection are required to receive two doses of the same vaccine. One who gets the first dose of Covishield cannot take second dose of Covaxin or vice versa. The vaccines are entirely of different types.

Covishield has been developed by the Oxford University scientists in collaboration with the pharmaceutical company AstraZeneca. This vaccine is manufactured in India by Serum Institute at Pune. Covishield is manufactured using a common cold virus from chimpanzees; about 20 per cent of the parts from the original virus are removed. In the gap obtained in this process, the surface protein- spike protein of the COVID19 virus is filled. It may be compared to grafting of saplings to produce a new plant of good yield. Here a virus is produced that looks like COVID19 virus, but is not harmful. Once inside a human body, these viruses do not produce sickness, but the human body is likely to produce antibodies. Next time, when real COVID19 virus attacks, these antibodies are expected to eliminate the viruses.

It is recommended to take two full doses of the vaccine, with a gap of around 4-6 weeks between two doses. The vaccine can be stored at temperatures between 2°C and 8°C. Its efficacy is said to be 62% to 70%.

Covaxin is India’s first indigenous vaccine against Covid-19.There is no foreign collaborators. .Bharat Biotech has developed Covaxin in association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, Pune (NIV). The ‘Covaxin’ vaccine is developed using traditional method. In this method, the dead COVID19 viruses — called “inactivated” in medical language are used. As they are inactivated, the viruses are not capable of infecting people or replicating on its own inside the body of a person after being injected. The human body may recognize the dead viruses and produce antibodies to eliminate live viruses if the person gets infected later.

It is said to have a strong immune response and the ability to neutralize the COVID19 viruses in the laboratory studies. The largest clinical trial on 25,800 subjects is planned, including few with comorbid conditions. The vaccine will be administered in two doses and stored at 2-8° degrees Celsius. The vaccine will be probably cheaper than all other vaccines.

Who will receive the vaccines in India?

The vaccination program is likely to start from 13th January 2021.The entire vaccination drive will be voluntary. There is no force or statutory requirement of vaccination as of now. In the future, vaccination might become one of the requirements for certain people in particular category. For example anyone taking an international flight may have to take vaccination well in advance. So far, no such regulations are in force.

The central government has announced that first preference will be the people who are in the forefront of India’s battle against COVID19 virus. These are healthcare workers, second in priority are policemen and other frontline workers. The government has informed that the vaccine will be administered to them for free. The third in the line will be the people above the age of 50 with co-morbid conditions. The government aims to complete this first phase of vaccinations to these groups by August 2021. At present it is not known when rest of the people will get the vaccine in India.

It is not yet known who will receive which of the two-Covishield or Covaxin. Mean times there are other firms who also will be ready with their products in the coming months. The DCGI has approved the Cadila Healthcare Ltd to conduct Phase 3 clinical trials of its ZyCoV-D vaccine candidate for Covid-19. The Pfizer vaccine and Russia’s Sputnik V vaccines are likely to be approved for use in India in the coming weeks.

Will the vaccine available for purchase?

Poonawalla, the CEO of Serum Institute had informed to media that the first 100 million doses of the vaccine were being sold to the Indian government at a “special price” of 200 rupees per dose, after which prices would be higher. The vaccine will be sold on the private market at Rs.1, 000 per dose.

In India government sponsored vaccination schemes for children are available free of cost in most of the government hospitals and primary health centers. Simultaneously these vaccines are also given at a cost in the private firms-hospitals and clinics. Similarly, it is possible that soon the private firms will be able to sell the COVID 19 vaccines to the prospective users. The price will be known later.

Safety and efficacy of COVID19 vaccines

Most of the people are concerned about the side effects of COVID19 vaccines than their efficacy. Like earlier vaccines, the approved COVID 19 vaccines are relatively safe. Most of the side effects of COVID 19 vaccination are comparable to other vaccinations. The most common side effect is soreness at the site of injection. Other side effects include fatigue, headache, muscle aches, chills, joint pain, and possibly some fever. These symptoms usually last for 24 to 48 hours, and not more than a few days. The side effects were more frequent after the second dose in the vaccine trials. These side effects are typical of the inflammation induced by vaccines and are a sign of the body’s immune response to the vaccine.

The efficacies of the vaccines vary in the clinical trials. The efficacy may be entirely different when the vaccines are used for general public on a larger basis. At present the Covishield is known to be 62% to 70% effective. It means if full two doses of vaccines are taken, chances of getting sickness from COVID 19 infection may be 30% to 38%. It means, if 100 people who have taken full two doses of the vaccine are exposed to COVID19 virus, 30 to 38 of them will get infection.

The efficacy of other approved vaccine, Covaxin is not yet known. However, Bharat Biotech MD Krishna Ella has assured that Covaxin is “200 per cent safe”.

Whether two doses of vaccine give life time protection?

At present most of the experts are not able to answer this question. No one knows how long the protection from the vaccination will last. The protection someone gets from an infection by the virus is called natural immunity. The natural immunity varies depending on the disease, and it varies from person to person. Since this virus is new, it is not known how long natural immunity might last. Current evidence suggests that reinfection with the virus that causes COVID-19 is uncommon in the 90 days after initial infection.

It is not known how long the immunity after vaccination will last. If immunity from real infection doesn’t last long, the immunity after vaccination also may not last for long. More data about these may be available in the coming months.

COVID19 vaccines and common man

As per now, the healthy person below the age of 50 years will not get the COVID19 vaccines from the government for at least for another 7 to 8 months unless he/she is a health worker or frontline worker. By that time the vaccines will be used on priority basis as explained above and more details about the need, efficacy and side effects will be known.

If one is above the age of 50 and having co-morbid conditions, vaccination is better and safer than getting the real infection. The real infection can be life threatening. Compared to this the side effects of the vaccine are minimal and not lethal as per the clinical trial reports.

For the general public, most important would be to verify the truth in the messages and information about the vaccine and vaccination in the social media. Already plenty of wrong information about vaccination is in circulation.

 

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Comment on this article

  • Joe Gonsalves, Mangalore

    Mon, Jan 11 2021

    Dr. Edward Nazareth has always shard his thoughts for the guidance and safety of people. It is true that long and protracted tests have got to be made before marketing medications. However in the situation the country is going through, certain short=cuts have been taken

    Dr. Nazareth presets his realistic views on the situation

    DisAgree Agree [2] Reply Report Abuse

  • Charles D'Mello, Pangala

    Fri, Jan 8 2021

    Whatever it is safe or unsafe but we need a vaccine which is clinically approved. Let it be Indian or the foreign one. There is no need of a medicine which is not proved. Yes emergency was there few months back. Now recoveries are more than infected, what is the emergency for the Government for approving these not proven vaccines....!!!!????

    DisAgree [1] Agree [8] Reply Report Abuse

  • Naveen, Mangalore

    Fri, Jan 8 2021

    Thank you for this well structured article. Gives a very good overview about the vaccine and the aspects related to it.

    DisAgree [1] Agree [4] Reply Report Abuse

  • C.G.Sequeira, Mangaluru

    Fri, Jan 8 2021

    Though the COVID 19 vaccines are approved, the general public is still worried about their safety. Thanks to Dr.Edward Nazareth for his informative article. Hope he also writes an article on COVID 19 vaccination dry run.

    DisAgree [2] Agree [5] Reply Report Abuse

  • John, Mangalore

    Thu, Jan 7 2021

    Jesus on vaccine is worse than virus ? in a message to John Leary dated Thursday, December 10, 2020.

    Jesus said: “My people, I have given you many messages NOT TO TAKE THIS VACCINE, which uses genetic materials that will PERMANENTLY change your DNA. I am making a point of this now because your medical people will soon be giving out this vaccine to supposedly heal you from the corona virus. This vaccine is worse than the virus, and you could die more from the vaccine than the virus itself. This plan of a virus and vaccine is part of a one world plan to reduce the population. If the authorities try to mandate this vaccine, I will call you to the safety of My refuges where you will be healed.”

    DisAgree [3] Agree [7] Reply Report Abuse

  • Rudolf Rodrigues, Mumbai

    Thu, Jan 7 2021

    Washington, Jan 7 (IANS): Nearly 4,400 adverse events were reported after people received the Pfizer-BioNTech Covid-19 vaccine in the US, with 21 cases determined to be anaphylaxis, according to a report by the Centers for Disease Control and Prevention (CDC).

    The US Food and Drug Administration issued an Emergency Use Authorization for Pfizer-BioNTech Covid-19 vaccine on December 11, 2020, administered as two doses separated by 21 days, reports Xinhua news agency.

    As of December 23, 2020, a total of 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine had been administered in the US, according to the CDC report.

    Reports of 4,393 adverse events had been submitted to the Vaccine Adverse Event Reporting System in the country.

    Among those, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis.

    Twenty-one cases were determined to be anaphylaxis, including 17 in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis, according to the CDC.

    Anaphylaxis is a life-threatening allergic reaction that does occur rarely after vaccination, with onset typically within minutes to hours, said the CDC.

    Locations administering Covid-19 vaccines should adhere to CDC guidance for use of the jabs, including screening recipients for contraindications and precautions, having the necessary supplies available to manage anaphylaxis, implementing the recommended post-vaccination observation periods, and immediately treating suspected cases of anaphylaxis with intramuscular injection of epinephrine, said the CDC.

    DisAgree [3] Agree [7] Reply Report Abuse

  • John, Mangalore

    Wed, Jan 6 2021

    A Western Doctor's opinion on COVID vaccines - part 2

    ...Additionally, PEGylated lipid nanoparticles have been shown to trigger their own immune reactions, and to cause damage to the liver.

    4. These new vaccines are additionally contaminated with aluminum, mercury, and possibly formaldehyde. The manufacturers have not yet disclosed what other toxins they contain.

    5. Since viruses mutate frequently, the chance of any vaccine working for more than a year is unlikely. That is why the flu vaccine changes every year. Last year’s vaccine is no more valuable than last year’s newspaper.

    6. Absolutely no long term safety studies will have been done to ensure that any of these vaccines don’t cause cancer, seizures, heart disease, allergies, and autoimmune diseases seen with other vaccines. If you ever wanted to be guinea pig for Big Pharma, now is your golden opportunity.

    7. Many experts question whether the mRNA technology is ready for prime time. In November 2020, Dr. Peter Jay Hotez said of the new mRNA vaccines, “I worry about innovation at the expense of practicality because they [the mRNA vaccines] are weighted toward technology platforms that have never made it to licensure before.” Dr. Hotez is Professor of Pediatrics and Molecular Virology & Microbiology at Baylor College of Medicine, where he is also Director of the Texas Children’s Hospital Center for Vaccine Development.

    8. Michal Linial, Ph.D. is a Professor of Biochemistry. Because of her research and forecasts on COVID-19, Dr. Linial has been widely quoted in the media. She recently stated, “I won’t be taking it [the mRNA vaccine] immediately – probably not for at least the coming year. We have to wait and see whether it really works. We will have a safety profile for only a certain number of months, so if there is a long-term effect after two years, we cannot know.”...

    DisAgree [1] Agree [9] Reply Report Abuse

  • John, Mangalore

    Wed, Jan 6 2021

    A Western Doctor's opinion on COVID vaccines - part 1

    This is a letter from Dr. Shallenberger to his patients explaining why the vaccine is unsafe. Frank Shallenberger, MD has been practicing medicine since 1973 and has been a Pioneer in Integrative Medicine since 1978.

    December 18, 2020

    Dear Patients and Friends,

    Last week I must have been asked 20 times about the new COVID vaccines.

    Here are my thoughts. Please pass this information onto many as you can.

    People need to have fully informed consent when it comes to injecting foreign genetic material into their bodies.

    1. The COVID vaccines are mRNA vaccines. mRNA vaccines are a completely new type of vaccine. No mRNA vaccine has ever been licensed for human use before. In essence, we have absolutely no idea what to expect from this vaccine. We have no idea if it will be effective or safe.

    2. Traditional vaccines simply introduce pieces of a virus to stimulate an immune reaction. The new mRNA vaccine is completely different. It actually injects (transfects) molecules of synthetic genetic material from non-humans sources into our cells. Once in the cells, the genetic material interacts with our transfer RNA (tRNA) to make a foreign protein that supposedly teaches the body to destroy the virus being coded for. Note that these newly created proteins are not regulated by our own DNA, and are thus completely foreign to our cells. What they are fully capable of doing is unknown.

    3. The mRNA molecule is vulnerable to destruction. So, in order to protect the fragile mRNA strands while they are being inserted into our DNA they are coated with PEGylated lipid nanoparticles. This coating hides the mRNA from our immune system which ordinarily would kill any foreign material injected into the body. PEGylated lipid nanoparticles have been used in several different drugs for years. Because of their effect on immune system balance, several studies have shown them to induce allergies and autoimmune diseases...

    DisAgree [2] Agree [14] Reply Report Abuse

  • Hegde, Bangalore

    Wed, Jan 6 2021

    While as always like in previous articles Dr Nazareth has explained brilliantly + methodical -
    (easy to understand language)--
    Confusion has been created by authorities / Certain officials in a sort of race -
    Since this is involving personal/individual health safety issues a very trustworthy panel should have been in charge to ensure full public confidence--
    alongwith proper data and Evidence based --
    Taking vaccine has unfortunately created a situation of whether --inviting TROUBLE!

    DisAgree [1] Agree [12] Reply Report Abuse

  • Bhaskar, Mangalore

    Wed, Jan 6 2021

    Another timely article. Thank you. Let's support our leaders and medical establishment that they will make the correct choices of vaccines for our population. Our Serum Institute is known around the world for it's efficiency and quality in producing medications and vaccines. India has handled the pandemic comparatively well as compared to many western nations.
    There are many citizens in the USA who don't trust their medical regulatory agencies ( CDC, FDA. NIH, etc.) due to past malfeasance and misrepresentations, and perceived monetary enrichment by allied medical company stockholders. For example the drug Remdesivir was given emergency use authorization on May 1 2020, and approved by the FDA on October 22. The USA government paid 1.5 billion dollars for 500,000 doses of the drug. The World Health Organization later released a warning against the use of Remdesivir for Covid 19 as it was shown to be ineffective in preventing or improving the outcome of the disease, but rather reduced the amount of time spent in the hospital usually by 2 days. Gilead stocks went up immediately to $64 dollars a share immediately after the announcement. The stock prices had fallen to as low as 6 dollars a share by November. Gilead has a long association with the FDA and NIH.
    There was one prominent example of vaccine failure in the USA back in 1976 with the approved Swine Flu vaccines. 40 million people received the vaccine, some who experienced mild symptoms of the flu. Eventually it was discovered that the vaccine produced an increased risk of the neurological disease Guillain - Barre syndrome (450 people nationwide), and the vaccination program was terminated.
    India recently made an attempt to get a waiver of "intellectual property rights" rules from the WHO for Indian production of various international vaccines, but the bid was defeated by western nations such as Canada, USA and EU. There is much profit in Covid vaccines in the western nations.

    DisAgree [2] Agree [7] Reply Report Abuse

  • John, Mangalore

    Wed, Jan 6 2021

    For these vaccines there were no animal trials conducted? Is Big Pharma using humans as guinea pigs? Are we able to survive next or future viruses or on long term will it damage the body immune system are some of the questions?

    Seems in the name of top priority and bringing out vaccines in a shortest possible time and for emergency use worldwide, animal trials have been bypassed for these corona vaccines. Previous mRNA vaccines for SARS had very negative reaction on animals and other effects also makes one a GMO as per following part of recent interview by Brian Shilhavy Editor, Health Impact News, of

    Dr. Dolores Cahill, PhD, is a Molecular Biologist/Immunologist and Professor at the University College of Dublin in Ireland. She is an inventor, founder and shareholder of companies, and has been granted & licensed patents in Europe, the USA & worldwide with applications in improving the early accurate diagnosis of disease (autoimmune diseases & cancer). She has more than 20 years of expertise in high-throughput protein & antibody array, proteomics technology development, automation & biomedical applications in biomarker discovery, diagnostics & personalized medicine. Dr. Cahill recently did an interview explaining how previous peer-reviewed studies on SARS Coronavirus mRNA vaccines conducted on animals have had very negative results, which is why one has never been approved for humans. She states: “When you inject it, this mRNA, why it’s so deadly, is that it now goes into your genes, and starts expressing. And it starts stimulating the immune response from inside your body, and you can’t get rid it because of the source of the viral protein. You now have become like a genetically modified organism.”

    DisAgree [2] Agree [13] Reply Report Abuse

  • Devd, Mangalore

    Wed, Jan 6 2021

    Most informative article by Dr Edward.
    As per US company claims they insist on people continue to wear masks, keep the distance & take all precautions as they are not sure or know infections will happen despite antibodies created by vaccines. If that is the case then what is the use of taking the vaccines which serve no purpose or failed to achieve the purpose which they promised to achieve.
    Some doctors in frontline have received some consent or refusal letters which state they will cause spread of the disease & will cause more deaths by refusing to take the vaccines now & might have to change their mind & take them in the end despite knowing vaccines doesn't guarantee any prevention of future infections & stop the need of social distancing or masks which are used to prevent the spread.
    In thousands of cases of experimental vaccine takers a few have died due to anaphylactic shock while some have developed Bells Palsy which they claim will last for a few days only. People have to take a wise decision whether they would fall in the high risk group of developing allergic reaction to new vaccine & have to sacrifice their life for the betterment of others or take a wait & watch step which is better as this infection only causes 0.003% deaths while recovery rate even among comorbid cases with right treatment is 99.997% which includes the 80% asymptomatic people who doesn't know it went in unless they get tested for any other reason.

    DisAgree [2] Agree [10] Reply Report Abuse

  • Rohan, Mangalore

    Wed, Jan 6 2021

    Dear Dr,
    One more excellent article . Gives us the much needed information. Thank you.

    DisAgree [2] Agree [4] Reply Report Abuse

  • Monty Dotor, Mangalore

    Wed, Jan 6 2021

    If a person is seropositive is there a need to take vaccine? Vaccines are for generating antibodies so logically speaking it should not be required.Also we do not know how long the antibodies will last, both naturally acquired or through vaccine.

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  • Venur Vinodh, Vidyagiri , Venur vinodvenur65@gmail.com

    Wed, Jan 6 2021

    No efficacy data indicated for Bharat Biotec. Is there any explanation for the same?
    Lawyer Vinod Venur

    DisAgree [1] Agree [8] Reply Report Abuse


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