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Will Pfizer Launch A COVID Vaccine By December’20?

Here’s the COVID-19 vaccine update: Ever since the COVID-19 pandemic struck, almost all countries across the world have been racing against time to formulate a coronavirus vaccine that can immunize us against the coronavirus. The virus has claimed millions of lives and has wreaked tremendous economic havoc. On top of that, scientists have realized that even if COVID symptoms go away, serious long-term effects are showing up which can become an even greater health crisis. The sooner the vaccine hits the market, the better.  

A number of vaccines, including 2 in India, are in the 2nd and 3rd phases of human trials. But our patience is wearing out. In the midst of all this gloom, US pharmaceutical giant Pfizer surprised everyone by announcing that its vaccine candidate will be marketed by December 2020 or January 2021 tops. Here’s what we know about the situation so far.

Pfizer’s corona vaccine update

Pfizer and its German partner BioNTech began human trials in June this year. Since then the vaccine has been tried on 44,000 in different stages. Officials at both pharmaceuticals have said that trials went on as expected and there were no set-backs. They expect the results of the trials to be in by the 3rd week of November. If everything is positive and there does not need to be a tweak in the formulation, Pfizer will apply for emergency authorization of the vaccine.  

Pfizer has said it would immediately roll out 40 million doses as soon as regulatory bodies give them the green light.  

What are the critics saying?

Scientists are skeptical and feel that Pfizer is rushing in order to stay ahead of its nearest competitors Moderna and AstraZeneca and be the first pharma to launch a COVID vaccine. For example, Pfizer will only wait for 32 infections among the 440,000 people it has tested the drug on before they analyze the results. Whereas Moderna and AstraZeneca will only carry out the first-look analysis after 53 and 75 cases have been confirmed in their trial groups respectively. This would give them a larger data pool to understand if there are any shortcomings with their vaccine.  

What this means for India

The world will soon find out how effective the Pfizer vaccines will be. We will want to carry out our own analysis as well for getting the corona vaccine in India. If Indian scientists are satisfied, then the government may approach the pharma giant for collaboration. But even if results are not satisfactory, we needn’t worry because we have already tied up with AstraZeneca and our indigenous vaccines Covax and Zydus Cadila have shown promising results. Everyone is hopeful that the vaccines will be ready by March 2021.  

In the meantime, what we can do is maintain COVID protocol and follow all hygiene guidelines. We need to stay at home as much as possible and if we step out, we need to wear masks and use sanitizers. Remember, we might have to wait for months before we get vaccinated. Even if the vaccine is available by March 2021, only frontline workers will be eligible for it. So let us all be patient and carry on with the COVID precautions.  

Where Are We In The COVID-19 Vaccine Race?

The COVID-19 outbreak has shaken the global health system and economy by its roots. This epidemic is continuously spreading and showing no signs of slowing down. Vaccination could be the only effective and economical means to control or stop this pandemic. Many research institutions and pharmaceutical companies worldwide are currently involved in the development of a suitable coronavirus vaccine.

What are the Stages of development for a covid 19 Vaccine?

The development of coronavirus vaccines consists of the following steps e.g. exploratory, pre-clinical and clinical stages.

1. Exploratory stage – It is the basic research in the laboratory of the conceptual idea and development of an antigen against the disease against which a vaccine needs to be produced which usually takes 2–4 years’ timeframe.

2. Pre-clinical stage of development – It uses a platform of tissue-culture and animal testing to assess the safety of the vaccine. They may also suggest the safest starting dose for the next phase of research as well as the safest method of administering the covid vaccine. This stage usually takes 1–2 years and out of 100 potential candidates, 6 usually pass through this stage.

3. Clinical stages of development – Consist of at least 3 stages and the 4th post-marketing safety assessment is also mandatory. These are performed on Human volunteers. 

List of all Covid Vaccines & their stages: 

The efforts on coronavirus vaccine began initially in China as soon as the outbreak of coronavirus erupted and then world-over as the disease was declared a pandemic by WHO. Eventually, each country got into the race of developing the vaccine to be 1st in the world to safeguard its population & have an advantage over other countries. 

Conclusion:
Covid 19 pandemic is raging, even escalating. That puts pressure on all the countries to rush for a covid vaccine. Under such pressure, countries may authorize emergency use of a vaccine on specified groups without waiting for the completion of Phase III trials which could be harmful. We all have shown great patience till now, let’s continue the same by taking all the safety measures & following Government guidelines.

COVID-19 vaccine drive –

More than 80 million  people in India have received at least one dose of a coronavirus vaccine and 11.1 million people have been fully vaccinated in what is the world’s biggest inoculation drive. Here’s how you can book a COVID-19 vaccine for your loved ones.

From March 1 onwards, all people above the age of 60 will be eligible to receive the COVID-19 vaccine.  This is the second phase of India’s COVID vaccination programme and it will benefit 10 crore people across the whole nation. 

VaccineDeveloped ByCountryStageUpdate
ChAdOx1-SOxford University and has been licensed to AstraZenecaThe United Kingdom  and IndiaPhase 3South Africa has halted use of the AstraZeneca-Oxford coronavirus vaccine after evidence emerged that the vaccine did not protect clinical-trial participants from mild or moderate illness caused by the more contagious virus variant that was first seen in the country.
BNT162b2 VaccinePfizer in collaboration with BioNTech & Fosun Pharmaceuticals USA, Germany & ChinaConcluded Phase 3 

 

U.K regulator on Dec 2 declared the vaccine for use.

FDA have described changes to the guidelines for the transportation and storage of the Pfizer-BioNTech vaccine. They explain that it can now be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to 2 weeks.
If the FDA grants Pfizer’s request, the change could significantly speed up the vaccine rollout in the United States.
EpiVacCoronaVektor Centre, NovosibirskRussiaGiven regulatory approval A clinical trial with 40,000 volunteers to begin soon
mRNA-1273 VaccineModerna along with NIHUnited StatesPhase 3vaccine shows ‘no specific safety concerns. Results of the first analysis to be published by end of November. Early data shows 95% efficacy. 
Sputnik V VaccineGamaleya National Research Centre of Epidemiology and MicrobiologyRussiaDeveloped. 

 

Inadequate reports to prove the Vaccine’s efficacy and safety.

Phase 3 results analysis shows 92% efficacy. Phase 2 & 3 Trials in India to begin soon. Approved in Russia. 
CovaxinBharat BiotechIndiaRollout begunThe most reliable longer-term protection against coronavirus is provided through vaccination, experts said noting that the immunity afforded by the presence of antibodies might be expected to last only several months.
ZyCoV-DZydus CadilaIndiaPhase 1 & 2Has also begun working on a COVID drug to treat patients
CoronaVac VaccineSinovac Life Sciences Co. Ltd. (China) in collaboration with Institution ButantanChina & BrazilPhase 3Trials halted in Brazil. Turkey and Indonesia begin late-phase human trials
Ad5-nCoV 

 

Vaccine

CanSino Biologics company in collaboration with Beijing Institute of BiotechnologyChinaPhase 3Russia & Pakistan to begin Phase 3 trials
NVX-CoV2373NovavaxUSPhase 3Signed an agreement with SII to provide vaccine to low and middle-income countries post-approval
Janssen COVID-19 vaccineJohnson & JohnsonUSPhase 3Preparations underway to roll out 1 billion doses in 2021
Sanofi COVID-19 vaccineSanofi Pasteur in partnership with Translate Bio & GlaxoSmithKline US & UKPhases 1 & 2Phase 3 trials to commence by end of December
     

The Russian Vaccine – Is The End Of COVID-19 Pandemic In Sight?


The vaccine race is on! Most countries of the world are trying to come up with their own vaccine and end the COVID-19 pandemic. In early August, Russian President Vladimir Putin announced that Russia has been able to produce the first COVID-19 vaccine in the world. Is the war against this dreaded pandemic finally over? Read on to find out.

The Russian vaccine: the status

Russia’s Gamaleya National Research Center for Epidemiology and Microbiology began human trials on their COVID-19 vaccine in June. In July, the chief researcher claimed that the trials had been concluded and they were completely successful. On   11th August, Russia announced that the vaccine has been approved, it is ready and the first batch will be rolled out towards the end of August. Mass vaccination will start in the upcoming months in Russia. The vaccine has been named Sputnik V after the Sputnik 1- the first satellite ever to be launched from Earth (launched by the former USSR).

What are the experts saying?

Initially, as expected, the common people around the world were excited. The pandemic has claimed far too many lives and has brought immense hardships to our lives.   And if finally, a country has produced the much-needed vaccine, shouldn’t that be a cause for celebration?

The experts don’t agree. Most countries of the world are not jubilant about Russia’s new vaccine and politics has nothing to do with it.

Medical and healthcare experts have actually raised an alarm that the vaccine would not be safe for use. The simple reason why they are not happy is – the vaccine production was rushed.

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Russia started human trials in June and they claimed in August that the vaccine was ready. According to experts, this was impossible as Human trials take more than 1-2 months for completion.

Another reason why experts are worried is that Russia did not even conduct the 3rd phase of human trials. The health crisis caused by coronavirus is severe. But that is no excuse to hurriedly wrap up human trials and forgo the 3rd phase. This could lead to a fresh round of health complications if people’s bodies cannot accept the new vaccine. Experts feel that to end coronavirus, Russia is about to do something that could endanger the lives of thousands of people.

What is India’s stance on Sputnik V

Although India has not made any public announcements regarding the Russian vaccine, India’s silence on this matter can be seen as a sign of disinterest in Sputnik V. Medical professionals in India are of the same opinion as their international colleagues. They feel that the vaccine may not be suitable for use.

But there is no need for Indians to despair. Even if we don’t start vaccinating in September or October like Russia, our own vaccine may not be that far off.

India is currently running phase 2 human trials on 2 indigenous vaccines-

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1. Covaxin which is being produced by Bharat Biotech, Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

2.  ZyCOV-D which is being produced by Zydus Cadila.

On top of that, we are collaborating with Britain on their Oxford-AstraZeneca vaccine. This vaccine too is in its trial phase in India and has shown a lot of promise.

So, let us be hopeful! The medical community is working round the clock to get a safe COVID-19 vaccine in the market. In the meanwhile, we can prevent the further spread of the infection by maintaining proper social distancing, practicing sanitization and self-hygiene and going out only when absolutely necessary.

All You Need To Know About The Oxford Vaccine’s Trial In India!


 

The COVID-19 pandemic is causing endless anxiety, fears and losses. The case count is increasing in every country and we are all scared. Everyone is asking when will there be a vaccine that will help us go back to normalcy?

Fortunately, a number of vaccine candidates are undergoing human trials worldwide, including 2 in our country. Recently, a vaccine from Oxford University has been getting a lot of attention from the media. What is it? And will it be available in India? Read on to know everything about this vaccine.

The Oxford-AstraZeneca Vaccine

The Oxford University in collaboration with pharmaceutical giant AstraZeneca prepared a coronavirus vaccine candidate called AZD1222. It has been tested on 1077 individuals in an 18-55 age group in 2 phases.  

The results, which were published in the Lancet journal, are very promising. It was found that the vaccine increased the number of antibodies by four times. The ability of the body to neutralize the coronavirus increased by 91% within a month of administering the vaccine. A second dose increased it to 100%. The vaccine has been shown to enhance T-cell immune response, which is crucial for preventing viral attacks.

More trials will be conducted in the US, Brazil, India and South Africa to find out if the vaccine is equally effective across age groups and ethnicities.

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Which phase of the trial will be conducted in India?

The Department of Biotechnology (DBT) of the Government of India has said that it is crucial to conduct a human trial in the country to make sure that the vaccine works on Indian people before the vaccination programme is rolled out.

DBT will conduct phase 3 trials of AZD1222. The Serum Institute of India has also sought permission from the Drug Controller General of India to carry out both phase 2 and phase 3 trials.

The trials are expected to start in early August and will conclude in December. Over the next few months, AZD1222 will be administered to more than 4000 people in India.

What are the 5 trial sites?

The 5 sites chosen by DBT where the trials will be conducted are-

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What does it mean for India?

Oxford University and AstraZeneca have chosen Serum Institute of India (the largest vaccine producer internationally) to be their partner in manufacturing AZD1222 when it has cleared all human trials.

Serum Institute of India (SII) has assured that all preparations are being taken to make sure that bulk production can start as soon as the vaccine is given the green light. Millions of doses will be ready to be rolled out right after the vaccine is approved.

Another question on everyone’s mind is what will the vaccine be priced at? Even though there is no clarity on that yet, SII has promised that access of all to the life-saving vaccine will be made possible with very affordable pricing. Some reports have hinted that it may be made free of cost through the Government’s inoculation programme.

Hopefully, we will have a vaccine soon. But until that happens, follow the coronavirus protocol, stay home as much as possible, and maintain hygiene and social distancing to keep your loved ones and your country safe.  

When Will The COVID-19 Vaccine Be Ready?

Given the current situation, we know that the best exit to the COVID 19 crisis is through a vaccine. So, the question on every individual’s mind is – When will the coronavirus vaccine be ready? The pandemic that struck the world in December 2019 and has already killed more than 319,000 people. Almost 4.81 million people are infected globally.

We are all living in a state of anxiety and uncertainty. We can’t even go out for the fear of catching the infection and infecting our families. At this stage, the only thing that can restore our lives to normalcy is a vaccine.

So, when will the vaccine be available?

Coronavirus and the global effort to discover a vaccine

The global community has realized that we need a vaccine that will teach our immune system to recognize the coronavirus (if it enters our bodies) and create antibodies that will destroy the viruses. This is how everyone can become immune to this deadly infection.

To that effect, countries have created task forces that are conducting extensive research into studying the biology of the virus and coming up with a vaccine.

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The progress so far

The race against coronavirus is breakneck and we have already made much progress-

1. Scientists in Seattle announced in March that they would start human trials soon. They have skipped animal trials and will be proceeding right on to testing on humans.

2. Virologists in Australia have formulated two tentative vaccines, which they are trying out on ferrets right now. Human trials began in late April.

3. GSK and Sanofi, the global pharmaceutical giants and rivals are joining hands to pool resources and create a vaccine.

4. In the USA, Bill Gates is funding 7 separate lines of research and all of them are making significant headway.

5. In Europe, the first human trial is underway in Oxford, England with 800 volunteers. Half of them will be administered a COVID-19 vaccine and the remaining will be injected with a special vaccine that prevents meningitis.

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6. China, where the pandemic originated, has deployed 1000 scientists to produce a vaccine. The academy of military Medical Sciences has claimed that it has developed a vaccine and is enlisting volunteers to test the vaccine. A Chinese company has also paid $133 million to purchase stakes of the German pharmaceutical company BioNTech to help it develop a vaccine.

7. Europe too is at the forefront of research. All European countries fund the Coalition for Epidemic Preparedness Initiatives, which is currently spearheading the research with 8 potential vaccines.

Where does India stand in the race to develop a vaccine?

India’s very own Cipla is trying to develop a drug that is effective against coronavirus. It believes that the required drug can be a combination of HIV, anti-flu and anti-respiratory illness drugs.

The Serum Institute of India is working on a $100 million budget and has come up with a vaccine that has already been tried on animals. They have sought permission for conducting human trials.

Scientists across the world are positive that the vaccine will be developed by the end of this year and distributed globally. This is the time for international collaboration because the fate of humanity is at stake.

After a long time, the whole world is united to get the vaccine ready as quickly as possible. And until the vaccine becomes available, follow social distancing and personal hygiene measures to keep you and your loved ones safe.

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