Reviews on COVID-19 Vaccine. “Esther Tahir”

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Reviews by Esther Tahir. 

Since the beginning of time human beings are expose to different kinds of infections and diseases. We are and have been dealing with Epidemics or Pandemics. We aren’t completely immune from the perils of our surroundings. Even today in the era of digital advancements where we can literally have everything we wish for, we have counter plans for almost everything but we still cannot completely predict what future holds. And with this uncertainty we are facing such menace today in form of COVID-19.

Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China. It was initially reported to the World Health Organization (WHO) on December 31, 2019. On January 30, 2020, the WHO declared the COVID-19 outbreak a global health emergency. On March 11, 2020, the WHO declared COVID-19 a global pandemic, its first such designation since declaring H1N1 influenza a pandemic in 2009. 

With such Pandemics we human being optimistically strive to fight whatever comes our way and ensure our survival. Survival is a basic human instinct and with this instinct we’ve started working on making vaccines to deal with this pandemic. Though we’ve lost 2.79 Million precious lives pharmacists and scientists have been researching, testing and are producing potential vaccine for COVID-19, number of clinical trials are still undergoing.

“Treatments save lives, but vaccines save populations. When you get a vaccine, it’s not just for yourself, it helps ensure that the transmission chain stops with you, and that helps keep your loved ones safe and healthy.”

Hanneke Schuitemaker

(The Global Head of Viral Vaccine Discovery and Translational Medicine and the Disease Area Stronghold Leader for Viral Vaccines at Janssen Vaccines & Prevention, a Janssen Pharmaceutical Company of Johnson & Johnson.)

The first mass vaccination program started in early December 2020 and as of 15 February 2021, 175.3 million vaccine doses have been administered. At least 7 different vaccines (3 platforms) have been administered.

WHO issued an Emergency Use Listing (EULs) for the Pfizer COVID-19 vaccine (BNT162b2) on 31 December 2020. On 15 February 2021, WHO issued EULs for two versions of the AstraZeneca/Oxford COVID-19 vaccine, manufactured by the Serum Institute of India and SKBio. WHO is on track to EUL other vaccine products through June.

The products and progress in regulatory review by WHO is provided by WHO and updated regularly.

The document is provided here  https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_16Feb2021.pdf

Once vaccines are demonstrated to be safe and efficacious, they must be authorized by national regulators, manufactured to exacting standards, and distributed. WHO is working with partners around the world to help coordinate key steps in this process, including to facilitate equitable access to safe and effective COVID-19 vaccines for the billions of people who will need them.

Vaccination in Pakistan

On March 20 2021 Dr. Faisal Sultan said that PM Imran was self-isolating at home after testing positive. PTI Senator Faisal Javed Through his Twitter announced that the First Lady Bushra Bibi had also tested positive.

There were different speculations on PM Imran Khan tested positive after being vaccinated, but later in the day, Dr Sultan addressed a media briefing to clear up misconceptions about the prime minister’s diagnosis two days after being vaccinated.

He said PM Imran had been advised to isolate at home and rest. “We are monitoring his health and clinical parameters.” He said that currently the prime minister was not in need of treatment or medical intervention.

He went on to say that it was important to understand how vaccines worked. “No vaccine works immediately after being administered. Antibodies can take at least two to three weeks to develop.”

He said that for two-dose vaccines, such as the one from Sinopharm, antibodies could take two to three weeks to develop after the second dose.

Current Scenarios

Pakistan will receive another batch of over a million COVID-19 vaccine doses from China next week, the country’s top health official said on Sunday.

Dr. Faisal Sultan, the prime minister’s adviser on health, said in a tweet that the country has placed orders for the purchase of 1 million and 60,000 doses of Sinopharm and CanSino vaccines from China respectively, which will be received within a few days.

Several million additional doses are in the pipeline and will be delivered in April, he added.

The development came amid reports that the country’s already sluggish vaccination campaign is likely to take a further hit, following the delay in the supply of 17 million doses of the Oxford-AstraZeneca vaccine being provided by the WHO-led COVAX program for developing countries.

The promised vaccines were slated to be received by the end of March. But India’s Serum Institute, which is supplying the doses to the world health body, has diverted supplies to meet domestic requirements.

Pakistan is currently vaccinating frontline healthcare workers and senior citizens using Sinopharm doses donated by China.

Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine19 March 2021. 

 

As of 17 March 2021, more than 120 million cases of COVID-19 infections, with more than 2 million deaths, had been reported globally.  Vaccination remains a critical tool to help prevent further illness and death and to control the pandemic.

So far, more than 20 million doses of the AstraZeneca vaccine have been administered in Europe and more than 27 million doses of the Covishield vaccine (AstraZeneca vaccine by Serum Institute of India) have been administered in India.

The GACVS COVID-19 subcommittee met virtually on 16 and 19 March 2021 to review available information and data on thromboembolic events (blood clots) and thrombocytopenia (low platelets) after vaccination with the AstraZeneca COVID-19 vaccine.

The subcommittee reviewed clinical trial data and reports based on safety data from Europe, the United Kingdom, India, and Vigibase, the WHO global database of individual case safety reports.

Based on a careful scientific review of the available information, the subcommittee came to the following conclusions and recommendations:

  • The AstraZeneca COVID-19 vaccine (including Covishield) continues to have a positive benefit-risk profile, with tremendous potential to prevent infections and reduce deaths across the world.
  • The available data do not suggest any overall increase in clotting conditions such as deep venous thrombosis or pulmonary embolism following administration of COVID-19 vaccines. Reported rates of thromboembolic events after COVID-19 vaccines are in line with the expected number of diagnoses of these conditions. Both conditions occur naturally and are not uncommon. They also occur as a result of COVID-19.  The observed rates have been fewer than expected for such events.
  • While very rare and unique thromboembolic events in combination with thrombocytopenia, such as cerebral venous sinus thrombosis (CVST), have also been reported following vaccination with the AstraZeneca COVID-19 vaccine in Europe, it is not certain that they have been caused by vaccination. The European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee has reviewed 18 cases of CVST out of a total of more than 20 million vaccinations with the AstraZeneca COVID-19 vaccine in Europe. A causal relationship between these rare events has not been established at this time.
  • Adequate education should be provided to health-care professionals and persons being vaccinated to recognize the signs and symptoms of all serious adverse events after vaccinations with all COVID-19 vaccines, so that people may seek and receive prompt and relevant medical care and treatment.
  • The GACVS subcommittee recommends that countries continue to monitor the safety of all COVID-19 vaccines and promote reporting of suspected adverse events.
  • The GACVS subcommittee also agrees with the European Medicines Agency’s plans to further investigate and monitor for these events.

The GACVS COVID-19 subcommittee will continue to review the safety data from all COVID-19 vaccines and update any advice as necessary. The WHO COVID-19 vaccine safety surveillance manual provides guidance to countries on the safety monitoring and adverse events data sharing for the new COVID-19 vaccines, and can be accessed here (https://www.who.int/publications/i/item/10665338400)

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