Tag Archives: Vaccine

AstraZeneca COVID-19 vaccine

The initial trial data for the COVID-19 vaccine that has been developed in a joint collaboration between Oxford University and AstraZeneca. The data has been widely awaited as the world looks forward to some good news on the front of a vaccine that could shield people from the deadly coronavirus outbreak that has already infected over 14 million people worldwide and killed over 6 lakh. 

The potential vaccine is already in large-scale Phase III human trials to assess whether it can protect against COVID-19, but its developers have yet to report Phase I results which would show whether it is safe and whether or not it induces an immune response. The developers of the vaccine said this month they were encouraged by the immune response they had seen in trials so far and were expecting to publish Phase 1 data by the end of July.

How does the Oxford-AstraZeneca vaccine candidate work?

When someone is infected with the Covid-19 virus (SARS-CoV-2), the reason it spreads in the body easily is because of the spikes on its surface. These spikes, known as the ‘spike protein’, allow the virus to penetrate cells and, thereafter, multiply. The vaccine developed by Oxford and AstraZeneca, which belongs to a category called non-replicating viral vector vaccines, tries to build the body’s immunity against this spike protein. The idea is to create antibodies to fight this spiked surface so that the virus does not even have the chance to penetrate the cells. The vaccine uses a different virus — in this case, a weakened version of a common cold virus (adenovirus) that infects chimpanzees — to carry just the code to make the spike protein, like a Trojan horse. The adenovirus, genetically modified so that it cannot replicate in humans, will enter the cell and release the code to make only the spike protein. The body’s immune system is expected to recognize the spike protein as a potentially harmful foreign substance and starts building antibodies against it. Once immunity is built, the antibodies will attack the real virus if it tries to infect the body.

Since the Covid-19 vaccine has been developed by a United Kingdom-funded university, UK will have intellectual property rights. Other countries such as India will need to enter into commercial deals or understanding via foundations such as Coalition for Epidemic Preparedness Innovations (CEPI) and Global Alliance for Vaccines and Immunization (GAVI). AstraZeneca also entered a deal with the Pune-based Serum Institute of India to supply one billion doses for low-and-middle-Income countries, with the first 400 million nicely before the end of 2020. It is not yet clear how many doses India will be able to land at first since the rollout of the vaccine will be subject to considerations that are commercial as well as that of equity. The World Health Organization’s chief scientist has described the Oxford vaccine as the leading candidate in a global race to halt the coronavirus pandemic that has killed more than 600,000 people. More than 100 vaccines are being developed and tested around the world to try to stop the coronavirus pandemic, which has killed more than 600,000 people and ravaged the global economy.

COVAXIN

What is Covaxin?

It has been developed by the company Bharat Biotech India (BBIL) in collaboration with ICMR’s National Institute of Virology (NIV). It is an “inactivated” vaccine — one made by using particles of the Covid-19 virus that were killed, making them unable to infect or replicate. Injecting particular doses of these particles serves to build immunity by helping the body create antibodies against the dead virus, according to BBIL.

News about Covaxin

Earlier this week, Bharat Biotech announced that it had developed a vaccine against the novel coronavirus, named Covaxin, together with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune. The company had also received permission from the Drug Controller General of India (DCGI) to begin human trials, expected to commence in August.

Bharat Biotech is a reputed drug manufacturer that delivers four billion doses around the world for infections like rotavirus, hepatitis, Zika, Japanese encephalitis and others. However, its claim that Covaxin is indigenous – advanced, among others, by managing director Krishna Ella – raises some doubts.

According to Bharat Biotech, Covaxin is an inactivated vaccine developed from an Indian strain of the novel coronavirus isolated by NIV. No further information has been provided, especially about the nature of the vaccine or how it was developed. There have been no prior announcements either about when the process of developing such a vaccine was begun.

ICMR transferred the strain NIV had isolated to Biotech Bharat on May 9. The company published its press release on June 29. So there were only 50 days in between, during which time the company should have developed the inactivated vaccine, conducted preclinical animal trials (with mice and hamsters, according to the company), and sent its reports to be evaluated and approved by DCGI. Although ICMR had promised to expedite the process, animal trials with mice typically take at least three months to conclude.

A related issue is that animal trials for COVID-19 can only be conducted with hACE2 transgenic mice, as ‘normal’ mice can’t get infected with the novel coronavirus. These mice need to be shipped from the US, Europe or China.

These issues therefore raise concerns about whether Bharat Biotech could really have proceeded to the human-trials phase of vaccine development within only 50 days of receiving the inactivated virus from NIV.

Collaboration with US company

Bharat Biotech has currently invested in two other vaccines: CoroFlu in collaboration with FluGen Inc. and the University of Wisconsin-Madison, and an inactivated rabies vaccine vehicle for coronavirus proteins developed along with Matthis Schnell, director of the Jefferson Vaccine Centre (JVC), Pennsylvania. The latter is of interest.

On May 20, Bharat Biotech announced its collaboration with JVC as well as the license it had received to conduct clinical trials, and to produce and deliver vaccines in 80 countries excluding the US, Europe and Japan. On April 7, JVC announced a promising vaccine candidate named Coravax.

Coravax uses an inactivated rabies vaccine to carry the spike protein of the novel coronavirus. The spike protein attaches to a host cell and causes an infection, so experts expected this vaccine to trigger a good immune response on the body’s part. Schnell corroborated this response following preliminary tests with animals. Schnell added that JVC would need one more month to complete follow-up studies.

Bharat Biotech hasn’t shared any technical details of Covaxin. But based on what we already know, there appears to be room for the possibility that Covaxin is Coravax by another name – and by another viral strain. And even if the vaccine is wholly indigenous, the timelines for the animal trials don’t line up.

When does ICMR plan to launch it?

Aiming to make it available for public use by August 15, Bhargava wrote to the 12 trial sites to ensure “all” clinical trials were conducted by then. While BBIL’s application with the Clinical Trials Registry of India (CTRI) shows it plans to complete enrolment of trial participants by July 13, Bhargava has directed the sites to complete enrolment by July 7.

Is this even achievable?

A vaccine usually goes through three phases of human trials. The Central Drugs Standard Control Organization has given approvals for phase I and II trials so far. According to details from CTRI, BBIL in its application estimated phase I and II trials to take a year and three months, including at least a month for phase I alone.

Experts have questioned how all three phases can be concluded within a month and a half. “I would find it very surprising if it is done. Even the most ambitious companies in the world that are in more advanced stages of development for their Covid-19 vaccines have a longer time-frame. Even having all the trial results, with safety and efficacy data, by August 15 is difficult. This raises several questions,” said Dr Anant Bhan, Researcher, Global Health, Bioethics and Health Policy.

While vaccine trials can be fast-tracked, it still takes over a year to launch the product, experts said. In a pandemic, emergency-use approval can be given if data from the first two trial phases is compelling enough, said an expert on condition of anonymity. This would allow the launch without the third phase being conducted, but this approval would likely be given with riders to submit additional data and adverse event reports.

CORONAVIRUS VACCINE DEVELOPMENTS

What is coronavirus?

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment.  Older people and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.

The best way to prevent and slow down transmission is be well informed about the COVID-19 virus, the disease it causes and how it spreads. The COVID-19 virus spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, so it’s important that you also practice respiratory etiquette.

At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments. So sooner or later, we are going to come up with a permanent solution for this virus too.

Vaccine developments

With confirmed COVID-19 cases worldwide surpassing 9 million and continuing to grow, scientists are pushing forward with efforts to develop vaccines and treatments to slow the pandemic and lessen the disease’s damage. Some of the earliest treatments will likely be drugs that are already approved for other conditions, or have been tested on other viruses.

As of May 8, two medications had received emergency use authorization (EUA) from the Food and Drug Administration (FDA): the antiviral remdesivir and a drug used to sedate people on a ventilator.

The FDA issued a EUA in March for the antimalaria drugs chloroquine and hydroxychloroquine, but later revoked it after studies showed that they’re unlikely to be effective in treating COVID-19.

EUA allows doctors to use these drugs to treat people with COVID-19 even before the medications have gone through the formal FDA approval process. These drugs are still being tested in clinical trials to see whether they’re effective against COVID-19. This step is needed to make sure the medications are safe for this particular use and what the proper dosage should be.

It could be months before treatments are available that are known to work against COVID-19. It could be even longer for a vaccine. But there are still other tools we can use to reduce the damage done by the new coronavirus, also known as SARS-CoV-2.

Antivirals

Remdesivir: Developed a decade ago, this drug failed in clinical trials against Ebola in 2014. But it was found to be generally safe in people. Research with MERS, a disease caused by a different coronavirus, showed that the drug blocked the virus from replicating. The drug is being tested in many COVID-19 clinical trials around the world. This includes studies in which remdesivir is being administered alongside other drugs, such as the anti-inflammatory drug baricitinib. The drug is also being tested in children with moderate to severe COVID-19. In late April, the drug’s manufacturer, Gilead Sciences, announced one of its trials had been “terminated” due to low enrollment. Gilead officials said the results of that trial had been “inconclusive” when it was ended.

A few days later, the company announced that preliminary data from another trial of remdesivir overseen by the National Institute of Allergy and Infectious Diseases (NIAID) had “met its primary endpoint.” Gary Schwitzer, founder of HealthNewsReview.org, though, said the researchers changed the primary endpoint 2 weeks before Fauci’s announcement. Schwitzer compared that to moving football goalposts closer to make it easier to get a touchdown. At the same time, another study published in The Lancet reported that participants in a clinical trial who took remdesivir showed no benefits compared to people who took a placebo.

Despite the conflicting results, the FDA issued an order on May 1 for the emergency use of remdesivir. In early June, federal officials announced their supply of remdesivir will run out by the end of June. Gilead is ramping up production, but it’s unclear how much of the drug will be available this summer.

Arbidol: This antiviral was tested along with the drug lopinavir/ritonavir as a treatment for COVID-19. Researchers reported in mid-April that the two drugs didn’t improve the clinical outcomes for people hospitalized with mild to moderate cases of COVID-19.

EIDD-2801: This drug was created by scientists at a nonprofit biotech company owned by Emory University. Research in mice has shown that it can reduce replication of multiple coronaviruses, including SARS-CoV-2.

Pharmaceutical company Merck and Ridgeback Biotherapeutics LP signed an agreement in May to develop this drug. It’s already being tested in a clinical trial in the United Kingdom. Unlike remdesivir, EIDD-2801 can be taken orally, which would make it available to a larger number of people.

Favipiravir: This drug is approved in some countries outside the United States to treat influenza. Some reports from China suggest it may work as a treatment for COVID-19. These results, though, haven’t been published yet. Japan, where the medication is made, is sending the drug to 43 countries for clinical trial testing in people with mild or moderate COVID-19. Canadian researchers are testing to see whether the drug can help fight outbreaks in long-term care homes.

Kaletra: This is a combination of two drugs — lopinavir and ritonavir — that work against HIV. Clinical trials are being done to see whether it also works against SARS-CoV-2. One small study published May 4 in the journal Med by Cell Press found that lopinavir/ritonavir didn’t improve outcomes in people with mild or moderate COVID-19 compared to those receiving standard care.

Another study, published May 7 in the New England Journal of Medicine, found that the drug combination wasn’t effective for people with severe COVID-19. But another study found that people who were given lopinavir/ritonavir along with two other drugs — ribavirin and interferon beta-1b — took less time to clear the virus from their body. This study was published May 8 in The Lancet.

Merimepodib (VX-497): This drug developed by ViralClear Pharmaceuticals Inc. has been shown previously to have antiviral and immune-suppressing effects. It was tested against hepatitis C but had only modest effects.

The company is running a phase II trial of this drug. People with advanced COVID-19 will be randomized to receive either merimepodib with remdesivir, or remdesivir plus a placebo. The company hopes to have results by late summer of this year.

WILL BABA RAMDEV’S MANTRA WORK THIS TIME TOO?

On 23rd of  June,2020 in a press conference held by Yoga Guru ,Ramdev Baba launched the “Coronil Kit”. As claimed by Baba Ramdev  ,the Coronil Kit is the only solution found till date against the pandemic. It is the first clinically  ,researched and tested medicine carried upon 280 patients in Haridwar, Delhi ,Meerut and Ahmedabad. The medicine which is  a joint effort by Patanjali Research Institute and National Institute of Medical Science, Jaipur  has shown 100% recovery rate in 7 days ,while 69% recovered within 3 days of time. During the launch, he continuously talked about immediately releasing the evidence of the research.

Coronil Kit

The corona kit consists of 3 medicines ,one of which is in liquid form, while the other two are in tablet form. The main ingredients in the tablet are Giloy, Tulsi and Ashvagandha. The entire kit costs around Rs.545. The kit would be available for free ,for those below the poverty line. The dosage prescribed for patients aged between 15-80 years of age is 2-2 tablet every half an hour after food ,to be taken along hot water. Whilst for those between the age of 6-14 years, would be given half the amount prescribed. The medicine would be initially available in the  Patanjali stores, but they’re very soon going to launch the e-commerce app, “Order Me” for online delivery.

According to the Government prescribed rules, any effort made without the permission from Ayush Ministry, is worthless. The Ayush Ministry has called for the full details about the medicine, since it’s unknown to them. They’ve  restricted them from advertising or selling the product, without their approval. The full details of the name of the company of the medicine, sample size ,the hospital where research is conducted. They’ve even asked the Uttarakhand State Licensing Authority to provide copy of the license issued to them. The Uttarakhand State Licensing Authority reported that Patanjali at the time of applying for the license, didn’t mention about the Covid-19.Instead ,they’d only approved license for being immunity boaster ,and cough ,fever. As a result, the Ayush Ministry issued circular by claim of misleading information, fake claims and misbranding. Before commenting anything on whether Patanjali violated the Protocol or not, they ’re waiting for the documents.

Recent news have proved how Patanjali had planned it to be a strategic move to earn lots of money , but seem to be failing instead. They’re in a total mess right now ,like the proper protocol for such trials is completely missing, besides having discrepancy with the CTRI. Inconsistencies which’ve risen have proved that only 100 were there for the trial  ,instead of 280 patients as reported. Out of this 100,half had taken the placebo drugs and only those patients who showed mild to moderate symptoms were the chosen ones.

Ayurveda has been an age long belief of Hindus, believing it has power to  cure them of any disease they want. Ramdev Baba had even before claimed of curing homosexuality, and had offered medicine with the power to make women conceive male child. It is because of such beliefs that Patanjali is now valued at Rs.3000 crore, and every here and now comes out with schemes to make money at the cost of people’s trust.

What Will Kill First?

Businesses have been suffering and reeling under the impact of the lockdown enforced due to the Corona Pandemic. Although the Indian Government has announced a 20 lakh crore stimulus package for the Indian economy, the small businesses and the daily wage earners continue to struggle. The majority are left questioning as to what will kill them first, the Coronavirus or hunger?

People are being laid off jobs continually. Businesses are closing down. The underprivileged without savings have been left relying on the substandard government rations and subsidies. The middle class continue to suffer a lot as they are neither eligible for the rations yet they continue to be laid off their jobs. People who are testing positive for corona and recovering are being treated as a social outcast and are being asked to stay away from the office. The economy is stuttering with a record low growth. People in the private sector are being to asked to do the usual job at a fraction of their earlier salary to help the company to recover the losses the company has suffered. Even though the markets are slowly opening up, the customers are staying away from the fear of contracting the deadly virus. The popular markets and malls are recording the lowest footfall they have ever seen.

People are dying and some are traumatised having to stay put in their house month after month. Depression and anxiety are becoming alarmingly common in society. People are only buying essential commodities and luxury items are being shunned. With low and uncertain streams of income, people have stuck to only buying daily essential commodities. The stock market has gone for a toss with record low Sensex and the share price of companies plummeting. The tour and travel industry have been suffocating and will continue to suffer for the years to come. It will take all the industries a lot of time to return back to normalcy.

The educational institutions have been rendered moot with all of them shut with no classes in their institutions possible. The exams are being cancelled and the students and their guardians are finding it extremely difficult to pay off the monthly fees. Some institutions like Don Bosco Liluah, St.John school based in Howrah, a city in West Bengal have made relaxation in the fees structure to assist the parents in this time of financial crisis.  However, the schools are suffering from a paucity of funds. The corona crisis has led to a financial emergency in almost all of the sectors in the country.

No one knows how long it will take for the world economy to recover even if a vaccine for Covid-19 is made available. The devastating impact of Corona has led to the loss of lives, daily livelihood and scarred the 21st-century human civilization for life. The daily wage earners and the migrant labourers are suffering a lot. Some have already lost their lives due to hunger and some have lost their lives in the process of having to travel back to their villages.

Everyone is hoping for the nightmare to end soon and for the world economy to get back on its feet and keep moving ahead. Some people keep stressing on the fact that they would rather die from the virus than die of hunger. Thus they continue to risk their lives of travelling for their jobs to earn their daily bread. The pitiable condition of India is only
deteriorating daily with India climbing to the 4th position in the list of Covid-19 positive cases. As Rahul Gandhi rightly pointed out, India is on its way to winning the “wrong race”.