Medical – Vishwa Arogya Sena

VA-SenaDecember 10, 2020

Starting with the elderly and front line workers, Britain began mass vaccinating its population on Tuesday, part of a global drive that poses one of the biggest logistical challenges in peacetime history

London:

Britain’s medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy warning about the shot.

Starting with the elderly and frontline workers, Britain began mass vaccinating its population on Tuesday, part of a global drive that poses one of the biggest logistical challenges in peacetime history.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said there had been two reports of anaphylaxis and one report of a possible allergic reaction since rollout began.

“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine,” MHRA Chief Executive June Raine said in a statement.

“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks… You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness.”

Anaphylaxis is an overreaction of the body’s immune system, which the National Health Service describes as severe and sometimes life-threatening.

The fuller guidance, clarifying that the main risk was from anaphylaxis specifically, was issued after consulting experts on allergies. The MHRA had initially advised anyone with a history of a “significant allergic reaction” not to take the shot.

Pfizer and BioNTech said they were supporting the MHRA’s investigation.

Last week, Britain’s MHRA became the first in the world to approve the vaccine, developed by Germany’s BioNTech and Pfizer, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.

A top U.S. official said on Wednesday that Americans with known severe allergic reactions may not be candidates for Pfizer’s COVID-19 vaccine until more was understood about what had happened.

Canada’s health ministry said it would look at the reported adverse reactions in Britain, but said adverse events were to be expected and would not necessarily change the risk/benefit of the shot, after the country approved the vaccine.

Allergic Reaction

MHRA chief Raine told lawmakers such allergic reactions had not been a feature of the Pfizer’s clinical trials

Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol.

However, the allergic reactions may have been caused by a component of Pfizer’s vaccine called polyethylene glycol, or PEG, which helps stabilise the shot and is not in other types of vaccines.

Imperial College London’s Paul Turner, an expert in allergy and immunology, who has been advising the MHRA on their revised guidance, told Reuters: “As we’ve had more information through, the initial concern that maybe it affects everyone with allergies is not true.”

“The ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk,” Turner told Reuters.

The EMA said in an email that all quality, safety and efficacy data would be taken into account in assessing the vaccine, including data generated outside the EU.

In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine’s efficacy and safety data met its expectations for authorization.

The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, professor of experimental medicine at Imperial College London, said was a very small number.

“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well,” he said.

However, Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic in Rochester, Minnesota, said that the MHRA and NHS had overreacted initially.

“I would not have broadened to the degree they did,” he said.

“It’s reasonable to let the world know about this, and to be aware of it in terms of people who have had reactions like this to vaccines. I think to say medicines, foods or any other allergies is past the boundary of science.”

VA-SenaNovember 23, 2020

An order to shut two evening markets in west Delhi till the end of this month for violating various coronavirus safety guidelines was withdrawn, hours after the notice was sent last night.

The Delhi government on Sunday had ordered the closure of two markets, the Punjabi Basti market and the Janta, in Nangloi area, till November 30 after it was found that wearing masks and social distancing were not being followed in these markets.

On Friday, Chief Minister Arvind Kejriwal said his government does not want to shut any market and asked representatives of market associations to provide masks to people not wearing it. Mr Kejriwal had held a virtual meeting with the representatives of market associations in the city.

As the capital struggles to contain the surge in coronavirus cases that have crossed 5.29 lakh, Mr Kejriwal had on November 17 said that his government has sought the centre’s go-ahead to allow it to shut for a few days markets that may emerge as COVID-19 hotspots.

VA-SenaNovember 19, 2020

The vaccine’s efficacy was found to be consistent across different ages and ethnicities – a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.

Pfizer Inc and BioNTech could secure emergency US and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.

The US Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.

“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.

The success rate of the vaccine developed by the US drugmaker and German partner BioNTech was far higher than what regulators had said would have been acceptable. Experts said it was a significant achievement in the race to end the pandemic.

Of the 170 volunteers who contracted COVID-19 in Pfizer’s trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.

“A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique,” said Enrico Bucci, a biologist at Temple University in Philadelphia. “Today is a special day.”

BioNTech’s Sahin said U.S. emergency use authorization (EUA) would be applied for on Friday.

An FDA advisory committee tentatively plans to meet on Dec. 8-10 to discuss the vaccine, a source familiar with the situation said, though the dates could change. The FDA did not respond to requests for comment.

COVID-19 RUNS RAMPANT

The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine showing 94.5% effectiveness.

“We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks,” U.S. Health and Human Services Secretary Alex Azar said.

The Moderna vaccine is likely to be authorized within seven to 10 days of Pfizer receiving its EUA, U.S. officials said, with states ready to begin distribution within 24 hours.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and destroyed economies and daily life.

The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations almost daily.

The Pfizer-BioNTech shot was found to have 94% efficacy in people over age 65, a particularly high-risk group.

“This is the evidence we needed to ensure that the most vulnerable people are protected,” said Andrew Hill, senior visiting research fellow at the University of Liverpool’s department of pharmacology.

VA-SenaOctober 1, 2020

The news deals a blow to President Donald Trump’s hopes of having an injection ready before the election to give his campaign a much-needed boost.

Washington, United States: US biotech firm Moderna won’t seek an emergency use authorization for its coronavirus vaccine before November 25, its CEO told the Financial Times on Wednesday.

The news deals a blow to President Donald Trump’s hopes of having an injection ready before the election to give his campaign a much-needed boost.

Stephane Bancel told the newspaper: “November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA (Food and Drug Administration) – assuming that the safety data is good, i.e. a vaccine is deemed to be safe.”

Trump, whose approval has taken a hit over his handling of the Covid-19 crisis, has frequently hinted a vaccine could be ready before the November 3 vote.This has raised concern among experts that his administration may attempt to interfere with the regulatory process for political reasons.The Republican repeated his claim on Tuesday night, during a debate with his Democratic rival, former vice president Joe Biden.”It’s a possibility that we’ll have the answer before November 1,” he said.

Moderna’s vaccine is one of 11 experimental vaccines in final stage trials.Another is being developed by Pfizer, whose CEO Albert Bourla has taken the position that his company may have a clear answer about whether their shot works by October.Most experts are skeptical of the claim, believing that the ongoing trials will not have sufficient statistical data to prove the drug’s safety and effectiveness by that time.Speaking to the Washington Post on Tuesday, Bourla denied he was attempting to curry favor with the president by making his October claim.

VA-SenaSeptember 29, 2020

MHA Unlock 5 Guidelines: Unlock 5 will likely come into effect on the following day – Thursday, October 1 – and is expected to stay in place till October 30

New Delhi: The centre is expected to announce guidelines for the fifth phase of easing of Covid-related restrictions, or “Unlock 5”, in the next couple of days as the current phase – “Unlock 4” – is due to end on Wednesday.

“Unlock 5” will likely come into effect on the following day – Thursday, October 1 – and is expected to stay in place till October 30.

While there is considerable speculation about what will and what will not be reopened, the Uddhav Thackeray-led government in Maharashtra has prepared guidelines to reopen restaurants starting October 1.

Dine-in service at restaurants in Maharashtra – the worst affected state in the country – have been shut since the first lockdown in March. Restaurants (outside containment zones) had been “unlocked” by in July, but the state opted against this given the high active caseload and daily increase.

Under “Unlock 4”, metro train services have been re-started (in a graded manner) across the country, and social, political, academic, sporting, religious and other functions are allowed with an increased limit of 100 attendees.

Swimming pools and indoor movie theatres, however, remain closed.

Metro services in major cities were reopened in stages with emphasis on cashless, or contactless, travel, social distancing and the use of face masks and sanitisers.

Previously metro services had been stopped and the number of people at functions was limited to 50, as part of the government’s attempts to limit physical contact between people and prevent the infectious coronavirus from spreading further.

“Unlock 4” also allowed schools across the country – which had been shut since the first Covid lockdown in March – to partially reopen from September 21.

Guidelines issued by the Home Ministry said students between Class 9 and 12 could come attend school in staggered shifts to clarify doubts from teachers, providing these schools were outside containment zones and they had parents’ permission.

The ministry also said up to 50 per cent of teachers and non-teaching staff could return to schools (while observing required hygiene protocols). The rest, the ministry added, could continue with online classes, as has become the norm in the pandemic.

The phased reopening of schools, however, was not made mandatory so some regions, including national capital Delhi, opted to keep them closed this month. Some others however, like Assam, Nagaland and Haryana, opted to reopen schools, in line with the centre’s guidelines.

Last month the centre issued guidelines for “Unlock 3” (August 1 to 31) that ended night curfew and allowed gyms and yoga institutes to reopen. All other restrictions remained – particularly those that involved large gatherings – remained in place.

Both “Unlock 3” and “Unlock 4” emphasised that inter-state travel is now permitted without the need for prior permission or e-passes.

India has recorded around 80,000 new Covid cases per day so far this month; 82,170 were logged over the past 24 hours, government data showed this morning. The country has logged over 60 lakh cases since the pandemic began in China’s Wuhan in December last year.

A strict lockdown – potentially the world’s strictest – was enforced by Prime Minister Narendra Modi in March, but the move left the economy in dire condition and prompted the government to begin a series of “unlocks” that started in June.

VA-SenaSeptember 29, 2020

Named after Satyajit Ray’s famed detective, the Feluda test, which is priced at ₹ 500 and can deliver a result in 45 minutes, is able to differentiate SARS-CoV-2 from other coronaviruses.

New Delhi: More accurate than a rapid antigen test and almost as quick, India’s CRISPR ‘Feluda’ COVID-19 test that changes colour on detection of the SARS-CoV-2 virus could be a cheaper, faster and simpler alternative to an RT-PCR diagnosis, say scientists.

Named after Satyajit Ray’s famed detective, the Feluda test, which is priced at ₹ 500 and can deliver a result in 45 minutes, is able to differentiate SARS-CoV-2 from other coronaviruses even if genetic variations between them are minute.

The Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Feluda test, developed by the New Delhi-based CSIR-Institute of Genomics and Integrative Biology (IGIB) and the TATA Group, received regulatory approvals last week from the Drug Controller General of India (DCGI) for commercial launch.

It meets high quality benchmarks with 96 per cent sensitivity and 98 per cent specificity for detecting the novel coronavirus, Debojyoti Chakraborty, a senior scientist at CSIR-IGIB and part of the team that developed the test, told PTI.

In any diagnosis, sensitivity is defined as the ability of a test to correctly identify individuals with the disease, whereas specificity is the ability of the assay to accurately identify those without the disease.

Similar to a pregnancy strip test, Feluda changes colour if the virus is detected and doesn’t need expensive machines for detection.

“The CRISPR technology uses a highly specific CAS9 protein to find and bind to the target COVID signature. This is then coupled with paper-strip chemistry to elicit a visual readout on a paper strip,” Mr Chakraborty explained.

The test can help the country, with the world’s second highest cases of COVID-19 at 60.74 lakh cases, ramp up testing of the disease quickly and economically, the researchers behind the test said in a statement.

Virologist Upasana Ray noted that the CRISPR based COVID-19 detection system is a cheaper option to RT-PCR tests, which cost over ₹ 1,600. The RAT and the Feluda are in the same price bracket.

FELUDA, an acronym for the FNCAS9 Editor-Limited Uniform Detection Assay, uses an indigenously developed, cutting-edge CRISPR technology for detection of the genomic sequence of SARS-CoV-2 virus, the scientists said.

CRISPR is a gene editing technology and is used in correcting genetic defects and treating and preventing the spread of diseases.

The technology can detect specific sequences of DNA within a gene, and uses an enzyme functioning as molecular scissors to snip it.

According to Mr Ray, Feluda is capable of detecting even low quantities of the genetic material of the novel coronavirus, based on very minute differences in their RNA – the genetic material of a virus

“Feluda is an alternative to the quantitative RT-PCR tests and is highly specific. It is capable of detecting low copy number nucleic acids (less viral RNA quantity) as well as single nucleotide variations,” Mr Ray, a senior scientist at CSIR-IICB, Kolkata, told PTI.

She explained that the tests are so specific that they can distinguish SARS-CoV-2 infections from other coronaviruses such as the one that caused the 2002-03 SARS pandemic.

“It can distinguish between SARS-CoV-2 and SARS-CoV sequences which differ by a single nucleotide. Unlike RT-PCR which requires expensive machines, Feluda is simple and can be used in laboratories as well as outside with a quicker turnaround time,” she added.

In May, the US granted emergency-use approval for the world’s first CRISPR-based test for COVID-19, developed by the Massachusetts Institute of Technology (MIT) and Harvard University.

The CRISPR Feluda test is the world’s first diagnostic test to deploy a specially adapted Cas9 protein, derived from Francisella novicida bacteria, to successfully detect the virus that causes COVID-19, the researchers said.

Other CRISPR?tests, like the one developed in the US, use CAS12 and CAS13 proteins to detect SARS-CoV-2.

Compared with a rapid antigen test, which interprets results in 30 minutes, Mr Ray said the Feluda test would take slightly longer, up to 45 minutes, but is more accurate and specific.

Rapid antigen tests detect the viral proteins or parts thereof whereas CRISPR detects nucleic acids, or RNA in case of COVID-19, Mr Ray said.

Chakaraborty noted that RT-PCR takes about 1.5 hours, trained manpower and a dedicated and expensive RT-PCR machine which is not widely available.

“Feluda gives similar sensitivity and specificity as RT-PCR but is inexpensive, requires a basic widely available PCR machine and doesn’t require extensive trained manpower. The chemistry and biology is of course different,” Mr Chakraborty added.

“This marks a significant achievement for the Indian scientific community, moving from R&D to a high-accuracy, scalable and reliable test in less than 100 days. The Tata CRISPR test achieves accuracy levels of traditional RT-PCR tests, with quicker turnaround time, less expensive equipment, and better ease of use,” the researchers said in their statement.

They described CRISPR as a futuristic technology that can also be configured for detection of other pathogens in the future.

VA-SenaSeptember 21, 2020

“The second round of countrywide serosurvey led by ICMR has been successfully completed. The final phase analysis of the survey is now underway and will offer a comparison with the results of the first survey #IndiaFightsCOVID19,” the ICMR said in a tweet.

New Delhi [India]: The Indian Council of Medical Research (ICMR) on Sunday informed that the second round of the countrywide serosurvey for COVID-19 has been successfully completed and the final phase analysis of the survey is now underway.

According to the Council, the containment zones, that refer to a specific geographical area where positive cases of coronavirus are found are dynamic in nature and they do not fit into nationally representative sampling

VA-SenaSeptember 18, 2020

At least half of the 7,033 Covid-19 cases and 115 deaths recorded in Gujarat’s Rajkot have been reported in the past month, official data shows.

Gujarat health department data shows that the number of Covid 19 cases increased from 3,289 on August 16 to 7,033 on September 16. The number of deaths rose to 115 from 54 in the same period.

According to the official data, Rajkot’s case fatality rate is the lowest in the state but some recent incidents have raised suspicion of there being some discrepancy in the data on the number of deaths. A local Gujarati daily in Rajkot reported on September 3 that 32 bodies were cremated/buried in Rajkot city the previous day as per Covid-19 protocols but only three deaths were recorded in Gujarat’s Covid health bulletin.

Rajkot municipal commissioner Udit Mishra denied hiding real death figures and said that a death audit committee determines the cause of deaths of Covid patients.

“Some people have confused routine deaths with Covid deaths. This may be because suspected Covid patients are cremated following the Covid protocol when they die. Covid death figures are decided by the audit committee,” said Mishra.

Former president of the Rajkot medical association (RMA) Dr Chetan Lalseta said: “One should not attribute all deaths to Rajkot district. Many terminally ill patients coming from the neighbouring districts also contribute to the high death numbers in Rajkot.”

Still, the situation turned so bad that the Gujarat government had to rush its health secretary Jayanti Ravi with a team of health experts and doctors to the home town of chief minister Vijay Rupani on August 31 to bring the situation under control.

“All efforts are being made to reduce fatalities in Rajkot district. Around 15 doctors from other districts would be stationed here and additional ventilators would be provided,” news agency PTI quoted her as saying on August 31.

As the cases have risen exponentially, residents have gone into isolation.

“We had no option but to go for a self-imposed complete lockdown as cases were rising very fast and lockdown is the only way to control the chain of transmission,” said Suresh Kumar, communications in-charge of the Rajkot wholesale textile merchants association.

He said the voluntary lockdown is almost complete with essential good shops opening for limited hours every day. “There is a huge fear among people as the virus is spreading very fast. People are not coming out of their homes voluntarily now,” he said

VA-SenaSeptember 18, 2020

Geneva, Switzerland: Too many doctors and nurses are paying the ultimate price while battling Covid-19, the World Health Organization said Thursday as it launched a charter aiming to boost safety for health workers.

The UN health agency said that the pandemic had exposed health workers and their families to “unprecedented levels of risk”.

While the coronavirus crisis has taken a heavy toll overall, data from many countries and regions show that healthcare workers have been infected at a far higher rate than the general population.

Health workers represent less than three percent of the population in most countries and less than two percent in low- and middle income countries, but account for around 14 percent of all Covid-19 cases reported to the WHO.

In some countries, the proportion has been as high as 35 percent, the body said.

On Wednesday, the International Council of Nurses said thousands of nurses had likely died in the pandemic, pointing to numbers from just 44 countries showing 1,097 deaths by mid-August.

“The Covid-19 pandemic has reminded all of us of the vital role health workers play to relieve suffering and save lives,” WHO chief Tedros Adhanom Ghebreyesus told a virtual briefing.

“We all owe health workers an enormous debt, not just because they have cared for the sick, but because they risk their own lives in the line of duty.”

The risks are not only physical. The WHO pointed to “extraordinary levels of psychological stress” on health workers, who have been asked to work long, draining hours battling Covid-19, living in constant fear of being infected.

Many are also living separated from their families, and facing social stigma amid fear they are carrying the virus. – Depression, anxiety –

These strains are increasing the likelihood of depression among medical professionals, who were already more at risk of suicide than the general public in a number of countries prior to the pandemic.

One in four health care workers surveyed for a recent study said they were struggling with depression and anxiety amid the pandemic, while one in three said they had suffered insomnia, the WHO said.

In its charter presented Thursday, the WHO emphasised the legal and moral obligations governments have to ensure the health, safety and wellbeing of health workers.

The charter among other things calls on countries to develop programmes that better protect the health and safety of medical workers, and to combine them with patient safety policies.

It also calls for better policies for protecting health workers from violence in the workplace, and for improving access to mental health support.

And it demands that minimum standards for patient safety, infection prevention and control, as well as for occupational safety are implemented across all care facilities.

Access to personal protective equipment (PPE), as well as sufficient training in how to use such equipment safely should also be guaranteed, it said.

VA-SenaSeptember 11, 2020

China’s only nasal spray vaccine against the coronavirus is expected to start phase I clinical trials in November, and it is recruiting 100 volunteers.

Beijing: China has approved for trials its first nasal spray vaccine to combat the novel coronavirus that has claimed over 904,000 lives and infected more than 27 million people globally, official media reported.

China’s only nasal spray vaccine against the coronavirus is expected to start phase I clinical trials in November, and it is recruiting 100 volunteers.

It is the only vaccine of its type approved by China’s National Medical Products Administration, the state-run Global Times reported.

The vaccine is a collaborative mission between Hong Kong and the Chinese mainland that involves researchers from the University of Hong Kong, Xiamen University, and Beijing Wantai Biological Pharmacy.

Microbiologist from the University of Hong Kong, Yuen Kwok-yung, said the vaccine stimulates the natural infection pathway of respiratory viruses to activate the immune response.

The nasal spray vaccination could generate double protection for vaccine recipients – influenza and the novel coronavirus – if it also contains influenza viruses including H1N1, H3N2 and B, Yuen said, adding that it would take at least another year to finish the three clinical trials.

A Beijing-based immunologist told the daily that compared with injections, a nasal spray vaccination is easier to administer and would also be easy to mass-produce and distribute as it adopts the mature influenza vaccine production technology.

The nasal spray vaccine uses live attenuated influenza vaccine; the other four technical routes China is using to develop the coronavirus vaccines are inactivated vaccines, adenoviral vector-based vaccines, and DNA and mRNA vaccines. The inactivated vaccine is estimated to be the earliest to be in the market, the report said.

The immunologist said the new vaccine may not cause systemic side effects, but side effects may occur in the respiratory system such as asthma and shortness of breath.

Ideally, scientists do not expect side effects except for minor nasal obstruction or rhinorrhea, Yuen Kwok-yung said.

It is not yet clear whether immunity generated from nasal spray vaccinations will last longer than for injected vaccines, the report said.

China has approved three COVID-19 vaccine candidates for clinical trials. It has also authorised emergency usage of COVID-19 vaccines developed by some select domestic companies.

“We’ve drawn up a series of plan packages, including medical consent forms, side-effects monitoring plans, rescuing plans, compensation plans, to make sure the emergency use is well regulated and monitored,” Zheng Zhongwei, head of China’s coronavirus vaccine development task force told the official media here last month.

An emergency use authorisation, which is based on Chinese vaccine management law, allows unapproved vaccine candidates to be used among people who are at high risk of getting infected in a limited period.

The Global Times has previously reported that employees of state-owned enterprises (SOEs) preparing to go abroad and the frontline medics have been offered two choices of domestic inactivated vaccine candidates developed by Sinopharm for urgent use.

The novel coronavirus, which originated from China”s Wuhan city in December last year, has claimed 904,485 lives and infected 27,902,002 globally. The US is the worst affected country with 190,887 deaths and 6,363,729 infections, according to the Johns Hopkins University data.