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Scientists announce important Zika milestone: First vaccine ready for human trials

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ZIKA Baby
Stella Guerra performs physical therapy on an infant born with microcephaly at Altino Ventura Foundation in Recife, Brazil. (Mario Tama/Getty Images)

Since the World Health Organization declared Zika a public health emergency in February, teams of scientists from all over the world have been attacking the virus from many different angles. They have made advances in understanding the structure of the virus, the historical path of the mosquitoes that carry it, and the risk to babies still in the womb — important knowledge but of little immediate practical use.

Now, the discoveries have finally led to something that might be able to stop the pathogen: a vaccine.

Pennsylvania vaccine maker Inovio Pharmaceuticals and South Korea’s GeneOne Life Sciences said Monday that they had received approval from U.S. regulators to start testing a DNA vaccine, known as GLS-5700, on humans. The early stage study will include 40 healthy subjects. It is designed to primarily assess the safety of the vaccine but will also measure the immune response generated by the injection. Zika, part of the flavivirus family of viruses that includes West Nile, dengue and yellow fever, is believed to be responsible for causing thousands of babies to be born with shrunken heads in Brazil and elsewhere. The Centers for Disease Control and Prevention recently detailed the cases of six babies born with the condition in the United States.

Inovio chief executive J Joseph Kim said the company, which is also working on vaccines for other devastating global viruses such as Ebola and Middle East Respiratory Syndrome (MERS), will begin the tests in the next few weeks and expect to report results later this year.

“We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers,” Kim said in a statement. “As of May 2016, 58 countries and territories reported continuing mosquito-borne transmission of the Zika virus; the incidences of viral infection and medical conditions caused by the virus are expanding, not contracting.”

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said he believes the world’s best hope against Zika is a vaccine and that, because of previous research on West Nile and dengue, a Zika vaccine should take less time to develop than vaccines for many other infectious diseases. The challenge is that Zika is unique among its related viruses because the others don’t invade the nervous system or developing fetuses because of blood-brain and placental barriers.

Researches who examined the virus’s structure with an electron microscope recently explained to The Washington Post what it is about its structure that might make it so dangerous:

It shares a basic structure with all flaviviruses: Genetic info in the form of RNA is surrounded by a fatty membrane, then encased in a protein shell with a 20-sided face. The protein shells are made of 180 copies of two different proteins, each composed of chains of different amino acids. Once inside a target cell, the virus breaks apart and forces the host to do its bidding, replacing the instructions coded into the cell’s DNA with those programmed by viral RNA.

Zika differs most from other flaviviruses at a spot thought to be crucial to the cellular break-in. At this site, a carbohydrate molecule — made of different sugars — sits on the virus’s protein shell. The so-called glycosylation site where Zika differs actually protrudes from the shell of the virus. In other viruses, similar protrusions act like strangers offering candy, tricking the human cell into binding with the invader. Like other flaviviruses, Zika seems to have a unique smattering of amino acids around that area.

The Food and Drug Administration has also been aggressive about trying to green-light other things that may be useful to the Zika fight. In May, it granted approval for emergency use of a Zika test from Altona Diagnostics. Another company, Hologic Inc., said its product — a diagnostic test used to identify snippets of the Zika virus in human blood — had received similar approval to be used in emergency cases in all 50 U.S. states, plus Puerto Rico and territories.

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India will start vaccination only after expert nod: PM seeks suggestions

The samples tested up to December 3 is 14,47,27,749 including 11,70,102 tested on Thursday, said the Indian Council of Medical Research.

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Vaccine Covid

New Delhi : Addressing an all-party meeting on Covid vaccines delivery and distribution, Prime Minister Narendra Modi said that state governments’ advise will be sought on the matter as to who all will get the inoculation first, and urged political leaders to write in their suggestions.

“Experts believe that the vaccines will be ready in few weeks, and Indian scientist are very confident of developing them,” Modi said.

Public health will be top priority for the government as pricing of the vaccines are concerned, he said adding that the vaccination process will start only after the experts give nod.

Government has suggested first vaccination for frontline Covid warriors and health workers to get vaccinated first.

The all-party meeting was called for suggestions for feedback on the progress made so far and was attended by all political parties in Parliament.

The Prime Minister had earlier interacted with team of developers and visited three cities on Saturday to conduct an extensive review of the vaccine development and manufacturing process, going to the Zydus Biotech Park in Ahmedabad, the Bharat Biotech in Hyderabad and the Serum Institute of India in Pune.

With 36,595 new coronavirus cases in the past 24 hours, India’s overall tally increased to 95,71,559 on Friday, as 540 more fatalities took the Covid-19 toll to 1,39,188, the Ministry of Health and Family Welfare said.

India witnessed a 3% rise in fresh cases and 2.7 rise in deaths since Thursday.

Currently, there are 4,16,082 active cases, whereas 90,16,289 patients have been discharged so far, including 42,916 discharged in the past 24 hours.

The recovery rate stands at 94.2 per cent and fatality at 1.45 as per cent, the Ministry said.

The samples tested up to December 3 is 14,47,27,749 including 11,70,102 tested on Thursday, said the Indian Council of Medical Research.

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AIIMS Director Pins Hopes On Five Covid-19 Vaccine Candidates

At least one locally-tested vaccine could get emergency use authorisation by the end of this month or early 2021, Dr Guleria says.

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COVID-19 Vaccine

AIIMS director Dr Randeep Guleria on Thursday pinned his hopes on the five Covid-19 vaccine candidates which are in advanced stages of clinical trial in India, stating they are logistically feasible for distribution in both urban and rural areas.

His assertion comes amid Pfizer-BioNTech’s anti-coronavirus vaccine getting emergency clearance in the UK, paving the way for mass vaccinations against the deadly novel coronavirus from as early as next week.

Dr Guleria expressed hope that by the end of this month or early next month, at least one of the five vaccines being locally-tested should get emergency use authorisation from the drug regulator to be administered to the public starting with priority groups.

According to sources, global pharma giant Pfizer had talks with the Indian government late August, but since then there has been no development.

During a briefing last month, NITI Aayog member (Health) Dr V K Paul, who also heads the National Expert Group on Vaccine Administration, said that sufficient doses of the Pfizer vaccine as required for the Indian population will not be available but the government is examining the possibilities and will work out a strategy (for its procurement and distribution) in case the vaccine gets regulatory approvals.

The requirement of extremely low temperature of -70 degree Celsius for storing the Covid-19 vaccine developed by Pfizer poses a big challenge for its delivery in a developing nation like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, Guleria said.

“Five vaccine candidates are in advanced stages of clinical trial in India and no significant serious adverse effects have been seen so far. Also, they are logistically feasible for distribution in a large country like India, both in its urban and rural parts.

“Hopefully, by the end of this month or early next month, at least one of them should get emergency authorisation from the Indian drug regulator for its distribution among Indian population,” he said.

The five vaccines are under different phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca Covid-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.

Another indigenously-developed vaccine by Zydus Cadila has also completed phase -2 clinical trial in the country.

Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) on Tuesday announced the start of adaptive phase 2 and 3 clinical trials for Covid-19 vaccine Sputnik V in India.

Also, Biological E. Ltd has started early phase 1 and 2 human trials of its Covid-19 vaccine candidate.

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Criminal networks could try to sell fake COVID vaccines physically and on internet, warns Interpol

The Interpol has asked police organisations to ensure “the safety of the supply chain” and said “identifying illicit websites selling fake products will be essential”.

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Vaccine

New Delhi, December 3: The Interpol has warned law enforcement agencies across the globe that organised criminal networks could try to advertise and sell fake COVID-19 vaccines physically and on the internet.

In an Orange notice issued to all 194 member countries on Wednesday, the Lyon-based international police cooperation body warned agencies to prepare for potential criminal activity in relation to “the falsification, theft and illegal advertising of COVID-19 and flu vaccines”.

“It also includes examples of crimes where individuals have been advertising, selling and administering fake vaccines,” a statement from the Interpol said.

The Interpol issues an Orange notice to warn of an event, a person, an object or a process representing a serious and imminent threat to public safety.

The CBI, which is the national central bureau for India, is tasked with coordination with the Interpol.

The warning came on the day the UK became the first Western nation to approve a COVID-19 vaccine, vaulting past the US and the European Union in the race to approve a vaccine.

The Interpol has asked police organisations to ensure “the safety of the supply chain” and said “identifying illicit websites selling fake products will be essential”.

“Criminal networks will also be targeting unsuspecting members of the public via fake websites and false cures, which could pose a significant risk to their health, even their lives,” Interpol Secretary General Jurgen Stock said in a statement.

“It is essential that law enforcement is as prepared as possible for what will be an onslaught of all types of criminal activity linked to the COVID-19 vaccine, which is why INTERPOL has issued this global warning,” the official said.

The Interpol cybercrime unit has analysed that of 3,000 websites associated with online pharmacies suspected of selling illicit medicines and medical devices, around 1,700 contained cyber threats, especially phishing and spamming malware making such operators even more potent of causing financial and health harms.

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