The emergency-use authorisation followed quickly after a panel of external advisers to the US Food and Drug Administration (FDA) voted unanimously, with one abstention, to recommend use of the vaccine on 17 December. One week earlier, the agency authorised a similar vaccine made by Pfizer of New York City and BioNTech of Mainz, Germany, about a week after UK regulatory authorities did the same, a report in Nature said.

The speed of these authorisations reflects the urgency of the pandemic, and is a testament to the scientific advances that made rapid vaccine development possible, said immunologist James Hildreth, president of Meharry Medical College in Nashville, Tennessee, at the panel meeting on Thursday. “To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement.”

The authorisation is a first for Moderna, a ten-year-old biotechnology company that had long pledged to revolutionize medicine by harnessing RNA as a therapeutic agent, but had yet to push a drug or vaccine all the way through to the clinic. It will join a growing list of organizations with coronavirus vaccines that are being deployed around the world, including teams in China and Russia.

In the United States, the vaccines offer a glimmer of hope amid the prospect of a tough winter. The country is logging thousands of deaths from COVID-19 each day, and this is expected to rise over the winter holiday season. Coronavirus infections are so rampant that Moderna was able to reach the primary endpoint of its trial five months earlier than expected, said Jacqueline Miller, senior vice-president and head of infectious diseases at the company.

RNA vaccine
Moderna’s vaccine, which was developed in collaboration with the US National Institute of Allergy and Infectious Diseases, works in the same way as the one produced by Pfizer and BioNTech. Both consist of RNA molecules encased in lipid nanoparticles. The RNA in both vaccines encodes a slightly modified form of the SARS-CoV-2 protein known as spike, which enables the virus to infect human cells.

Once taken up by cells, the RNA is used to produce the protein, which then triggers an immune response. The RNA does not enter the nucleus where the cell’s genome resides, and is degraded by the cell within a day of the injection.

COVID vaccine excitement builds as Moderna reports third positive result
Like Pfizer’s vaccine, Moderna’s seems to be highly effective — about 94% — at preventing symptomatic SARS-CoV-2 infections. Its safety profile is also similar to Pfizer’s, with fatigue, headaches and pain at the site of injection among the most often cited side effects.

Since the Pfizer vaccine was rolled out in the United Kingdom and the United States, there have been occasional reports of recipients experiencing severe allergic reactions called anaphylaxis after being injected. There have been no signs of such reactions so far in the Moderna trial, which excluded people who have had anaphylactic reactions to previous vaccines, but not those with other allergies, such as reactions to food.

The two vaccines differ in the composition of the lipid nanoparticle that encases the RNA, and Moderna’s formulation allows the vaccine to be stored at higher temperature than Pfizer’s, which must be kept at −70 °C, much colder than a normal freezer. Moderna’s vaccine can be stored in a −20 °C freezer for 6 months, and in a refrigerator (at about 4 °C) for 30 days. This promises to streamline the logistics of deploying the vaccine, particularly in rural areas and in countries with limited health-care infrastructure.

FDA advisers spent much of the 17 December committee meeting discussing when and how to offer a vaccine to participants in the placebo arm of Moderna’s trial after an emergency-use authorization is granted. Once a coronavirus vaccine becomes available, participants might choose to leave the trial to guarantee that they can get a jab. Maintaining the integrity of clinical trials after vaccine authorization — to collect data on long-term safety and the duration of protection — is a looming challenge for developers.

Last week, Pfizer proposed that when its participants become eligible to receive a vaccine as part of a national roll-out, study investigators will tell them whether they received the vaccine or a placebo. Moderna has instead proposed to ‘unblind’ its whole trial at once after it receives an emergency-use authorization, telling all of its participants which treatment they have received, and offering to vaccinate those in the placebo arm using doses that had already been set aside for the clinical trial.

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US regulators are now weighing in whether to grant emergency use authorisation for Moderan vaccine. A panel of outside advisers to the US Food and Drug Administration encouraged the emergency use of Moderna vaccine.

Early data from the trials of the coronavirus vaccine candidate being developed by Oxford University and AstraZeneca show two full doses of the vaccine give better immune response than the previously tried one full dose and a half-dose booster.

Developers of the vaccine candidate have already published late-stage trial results showing higher efficacy when a half dose is followed by a full dose, compared to a two full-dose regime.

Meanwhile, AIIMS- Delhi is reportedly unable to find enough number of volunteers for the Phase 3 trials of Covaxin, a coronavirus vaccine candidate being developed by Bharat Biotech and ICMR. AIIMS officials have observed people are unwilling to participate in the trials thinking a vaccine would be anyway be available soon.

The All India Institute of Medical Sciences (AIIMS) in Delhi is one of the sites conducting the final phase of the trial of Covaxin and it needs around 1,500 volunteers.

“We wanted 1,500-2,000 participants but so far, we have been able to recruit only around 200 participants. People are unwilling to participate in the exercise thinking why take part in a trial when a vaccine would be available soon for everyone,” Dr Sanjay Rai, professor at AIIMS and also the principal investigator of the study, said.

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The total coronavirus cases climbed to 96,77,203 with 32,109 new infections being reported in a day, while the death toll crossed to 1.4 lakh with 391 new fatalities.

At 3,96,729, the Covid-19 active caseload in India is now below the 4-lakh mark.

As per Union Health Ministry data on Monday, total discharged cases in India stands at 91,39,901 with 39,109 new discharges in the last 24 hours.

India’s Covid-19 tally had crossed the 20-lakh mark on August 7, 30 lakh on August 23 and 40 lakh on September 5.

It went past 50 lakh on September 16, 60 lakh on September 28, 70 lakh on October 11, crossed 80 lakh on October 29, and surpassed 90 lakh on November 20.

According to the Indian Council of Medical Research (ICMR), a cumulative total of 14,77,87,656 samples have been tested for COVID-19 up to December 6 with 8,01,081 samples being tested on Sunday.

The Union health ministry had said earlier that the country does not need to vaccinate all of its 1.3 billion people if it manages to break the transmission of coronavirus disease.

Meanwhile, the Serum Institute of India have become the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford Covid-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large.

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Emirates airline will partner with global pharmaceutical companies, including Pfizer to help with distributing its COVID-19 vaccine.

Emirates president Tim Clark said the airline is working closely with American multinational Pfizer to develop methods to transport the vaccine.

“The industry is trying to establish best practice involving the third-party supply chain and this logistical exercise, to ensure we get them [vaccines] to the markets that need them so badly, and basically that’s the whole planet,” Clark told

CNBC in an exclusive interview on November 15. “The logistics of distribution of this vaccine of this nature, given the conditions under which it has to be shipped – it’s going to be a challenge for the industry. We’re working on trying to move this Pfizer vaccine in specially designed containers on our planes, in our holds, and in the cabins, and keeping them at that level through the distribution point,” he added.

The vaccine has to be kept at a temperature around minus 70°C for optimal efficiency.

Last week, Pfizer and its German trial partner BioNTech announced that their Covid-19 vaccine is more than 90 per cent effective. The data comes from ongoing Phase 3 clinical trials. While reports indicate the vaccine may cause side effects, such as aches and fever, they are not worse than what is often seen with other vaccines.

The Pfizer and BioNTech vaccine is one of 11 around the world in Phase 3 clinical trials, which involve thousands of participants. Other vaccine candidates in clinical trials around the world include vaccines from Moderna, AstraZeneca and Johnson & Johnson.

If the vaccine receives approval for widespread use, a maximum of about 50 million doses would be available this year, with capacity for 1.3 billion more to be manufactured in 2021, according to Pfizer.

Clark said the Pfizer vaccine, and others in development, could have a positive impact on the global economic recovery, the aviation sector and global aviation demand.

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The phase-III human clinical trial began at the Sassoon General Hospital in Pune on September 17. King Edward Memorial (KEM) Hospital in Mumbai on September 23 began the phase II and III trials of the coronavirus vaccine.

Some participants in the trials for the coronavirus vaccine have also received their second doses and have not reported any adverse side-effects.

However, some did develop a fever after the dose of the coronavirus vaccine, but top scientists said that those are mild reactions and should not be worried about.

Some investigators also said that developing a fever is considered a common and mild side-effect of vaccines.

In September, Aztra Zeneca Plc said it has paused a late-stage trial of one of the leading coronavirus vaccine candidates after an unexplained illness in a study participant. After reviews the safety of the vaccine and its procedures, the human trials were resumed.

The Pune-based Serum Institute of India (SII) has partnered with British-Swedish pharma company AstraZeneca for manufacturing the coronavirus vaccine candidate, being developed by the University of Oxford, UK.

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All vaccines consists of an immunological agent called ‘adjuvant’, which makes the vaccine more efficient by strengthening its immune response. With the help of adjuvants vaccines can produce more antibodies, that helps in developing long-lasting immunity against the disease in the recipient.

One such adjuvant is squalene, natural oil that is present in the liver of sharks. In order to obtain one tonne of squalene, approximately 3,000 sharks needs to be killed.

As per the date published by the World Health Organisation (WHO) and Regulatory Affairs Professionals Society (RAPS), 17 out of the 176 candidate vaccine undergoing evaluation, have been reported to use these adjuvants.

Shark Allies, a California-based conservation group, has warned that in order to create one dose of COVID-19 vaccine each for every single person on the planet, about 2.5 lakh sharks will have to be killed for their liver oil. However, if two doses are required per person, then the number of sharks would double to 5 lakh.

While squalene is also found in the livers of many other animals, sharks remain the major commercial sources for the natural oil.

As per estimates made by conservationists, around 30 lakh sharks are killed every year so that people can utilise squalene in cosmetics, machine oil, and other products. British pharma giant GlaxoSmithKline, which has announced mass production of 100 crore doses of the COVID-19 vaccine, has already been using shark squalene to make flu vaccines.

Conservationists fear that this sudden spike in demand for mass production of vaccines will not just lead to mass murder of sharks ,but may eventually lead to their endangerment as well. These top predators do not reproduce in huge numbers.

To protect the shark species, scientists have been actively working on a synthetic version of squalene made from fermented sugar cane.

But with such an enormous, urgent, and ever-increasing requirement for vaccines against the novel coronavirus, which has so far infected 3.3 crore and killed 10 lakh people around the world, the number of sharks sacrificed for its production may even exceed the predicted number and continue to soar higher.

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The announcement came in the wake of the novel coronavirus pandemic that has infected more than 20 million people and killed nearly 750,000 worldwide, thus, crippling world economies.

The president has asked Health Minister Mikhail Murashko to keep him informed about the Covid-19 vaccine, while at the same time noting that he knows “it works quite effectively” and “forms a stable immunity”, according to Russian news agencies.
“This morning, for the first time in the world, a vaccine against the new coronavirus was registered” in Russia, Putin said during a televised video conference call with government ministers.

Putin further thanked everyone who worked on the vaccine’s development and described it as “a very important step for the world”. He hopes the country’s research body will soon start mass production of coronavirus vaccine.

“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin.

He emphasized that the vaccine underwent the necessary tests. He added that one of his two daughters has received a shot of the vaccine and is feeling well, according to reports.

However, the vaccine’s registration is conditional and trials will continue while production gets underway, said Murashko.

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That the first stage trials of vaccines being developed in the United States and the United Kingdom have been successful is a good indication that a vaccine for the infection would soon be available. 

There are reports that the first stage trails of the vaccine being developed by AstraZeneca PLC in association with Oxford University have been successful. Last week, US-based biotech company Moderna Inc had released the results of the first level experiments. Experiments are under way in many countries, including India. 

The results of the experiments of the vaccine developed by Oxford University published in The Lancet medical journal reveal that the vaccine doesn’t have any dangerous side effects. It has been found that antibodies and T-cells have developed in the people who have undergone treatment with the vaccine. It shows that the vaccine has been successful. Last stage experiments are under way in Brazil and South Africa and second stage experiments will start in the US soon.

In the US, vaccine production has started along with the testing of the vaccine. This is to make the vaccine available to the public at the earliest if the experiments are successful. Steps for production have been adopted not even considering the initial monetary losses.

Research and experiments are under way in India too to develop a vaccine. The Serum Institute of India has sought permission for the procedures. The institute has said that production of the vaccine will start without much delay. The institute has entered into contract with the many companies that are conducting experiments in the world including the British Company AstraZeneca. Serum institute has entered into a deal for production of the vaccine in India if the experiments being conducted by these companies are successful. This would help avoid any delay. 

The authorities have later withdrawn the statement that the vaccine being developed by Bharat Biotech in association with National Institute of Virology would be ready by August 15. Experts had pointed out that taking into account the time needed for experiments this would be practically impossible to meet. 

Many states in India are facing the threat of community spread even if they haven’t officially declared it. It was quite shocking to learn that 23.48% of the population in Delhi has been affected by the infection. The news of the success of the first level of experiments comes as a relief at this stage.

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The coronavirus, that originated from a seafood market in Wuhan is continuing to spread chaos in all nooks of the planet. With a rising number of positive cases and deaths, the pandemic has shattered the economic balance of many countries. In the meantime, researchers at the Sechenov First Moscow State Medical University, Russia has successfully completed the world’s first coronavirus trials on volunteers.

A milestone development by Russian researchers

Vadim Tarasov, the director of the Institute for Translational Medicine and Biotechnology told Sputnik that the first group of volunteers who were part of this study will be discharged on July 15, while the second group will leave the clinical setting on July 20. It was on June 18 that researchers began the clinical trials of this experimental vaccine candidate developed by Russia’s Gamalei Institute of Epidemiology and Microbiology.

“Sechenov University in a pandemic situation acted not only as an educational institution but also as a scientific and technological research center that is able to participate in the creation of such important and complex products as drugs … We worked with this vaccine, starting with preclinical studies and protocol development, and clinical trials are currently underway,” said Tarasov.

Uncertainty surrounding coronavirus mutation capabilities

Recently, several studies conducted by international researchers had suggested that coronavirus has already mutated to more than 33 different strains, and some of them have emerged as the lethal form of the virus. The study report has shocked many medical experts, and they now believe that the entire global healthcare sector has underestimated the mutation capabilities of this pathogen.

As different strains of coronavirus have affected people in different parts of the world, medical experts strongly believe that finding an overall cure for COVID-19 will not be an easy task.

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The Indian Council of Medical Research (ICMR) has partnered with Bharat Biotech International Limited (BBIL) to fast track clinical trials of the indigenous COVID-19 vaccine. ICMR’s National Institute of Virology (NIV) in Pune has provided the virus strain to BBIL to develop the vaccine.

The clinical trials will be held in 12 institutes across the country. In a letter to these institutes, the ICMR stated that it aims to launch the vaccine for public health use by August 15, after completion of all clinical trials.

Meanwhile, India’s second COVID-19 vaccine produced pharma giant Zydus Cadila got approval from the Drug Controller General of India (DCGI) to conduct phase I and phase II human clinical trials.

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