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Moderna CEO states that expecting a vaccine approval by October is unlikely

Out of the nine US companies that are in their final stages of clinical trials for vaccine development against Copvid-19, Moderna becomes the first biotech firm to publish the blueprints of its study on Thursday, September 17, 2020.

Following this, Pfizer, another US-based biotech firm is currently in the later stages of its phase-3 clinical trials. Additional pressure is now faced by the company after Moderna has already released its study layout. The CEO of Pfizer has repeatedly claimed that the company will have its final results by October, as expected by the president.

In the run-up to the upcoming US-elections in November, the US government led by Donald Trump has been pressurizing the organizations involved in the Covid-19 vaccine development, to lay off the criticism faced by them for poor management of the pandemic.

On Wednesday, September 16, 2020, the US president made a statement claiming that the vaccine will gain approval by the month of October. This raises concerns that the White House will be pressurizing the Food and Drug Administration (FDA) for approval of their vaccine which might be troublesome regarding the effectiveness and safety of the drug.

The healthcare experts and the officials in the Republican President’s Administration say that it is nearly impossible to predict the results of ongoing trials and it is unlikely to expect a vaccine approved by the end of this year, leave alone by the end of October.

Joe Biden, presidential nominee from the Democratic Party made a statement on Wednesday, September 16 that Donald Trump cannot be trusted in matters related to his response to his claims of having an approved vaccine ready by October.

The CEO of Moderna said that they will be finalizing the effectiveness of the vaccine by November and that expecting this to be done by October is far-fetched.

The immunization trials are not that easy. Moderna officials claim that the results are studied by comparing a group of people who are naturally infected by the virus, with another group that has been administered with the vaccine. The dropping rate of infection in the USA will further delay this process, maybe till December.

A total of 25,296 volunteers have been registered by Moderna on Thursday, September 17, for its phase-3 clinical trials, out of which 10,025 have been administered with second dose of the drug after 28 days of the first dose. Around 28% of the participants are from various racial minority groups, to obtain statistically representative results for various communities hit disproportionally by the pandemic.

The Covid-19 infections that occur only after 2 weeks of the second dose of test vaccine administration are recorded, to give the vaccine sufficient time to start acting.

The trial protocol of Moderna has the key information for stopping rules, interim analyses, and efficacy assumptions as stated by the director of the Scripps Research Institute, Eric Topol. He further added applause for the transparency of Moderna.

The final stage of vaccine development is the phase-3 clinical trials, in which the drug is administered and studied on human participants to test its side-effects, safety, and effectiveness.

A committee of independent experts has been finalized for short-term analysis of the trials to verify the high statistical threshold of vaccine effectiveness and to record any serious side-effects. As per the FDA, the minimum value of percentage for a vaccine to gain approval is to reduce the infection chances by 50%.

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Congress slams the decision of Rajya Sabha Chairman of adjoining the Covid-19 debate with the Health Minister’s statement clarifications

Today the Upper House of the Parliament is set to have its first debate on the Covid-19 pandemic in response to the continuous criticism it has been receiving from the opposition parties. The government will be focusing upon its successful response to the pandemic in terms of recovery rate and low mortality rate for Covid-19 in comparison to other countries.

The chairman of Rajya Sabha, Venkaiah Naidu, has decided to adjoin the Covid-19 debate with the Health Minister, Harsh Vardhan’s clarifications on his statement. This move has come under a furor from opposition parties especially the Congress.
On September 15th, 2020, India accounted for 91,136 new cases of Covid-19 making the total number of active cases cross 5 million. The number of cases has been increasing rapidly for the past few months disproving the prediction by NITI Aayog, signifying that at present, the rate of transmission of this virus is very high in India. It also accounts for the worst-ever daily infection rate in the world.

India is the second-worst hit country by the Covid-19 pandemic followed by Brazil. USA remains the worst-hit country with 6.69 million cases. In this context, Congress aims at raising the questions of a rapidly contracting economy of the country which has contracted by 23.9% in the first quarter of this financial year. The party also seeks a full-grown separate discussion on the loss of livelihoods for millions hit by the pandemic.

Jairam Ramesh, the Congress Chief whip, said in a letter to the Rajya Sabha chairman that if the parties cannot have a full-fledged discussion on the Covid-19 situation without being circumscribed by the minister’s statement then there was no point of having the Rajya Sabha session. He also added that the decision of combining the debate discussion with the health minister’s statement clarification runs contrary to the assurance given by junior minister for parliamentary affairs, V Muraleedharan to him, that the two will be taken up separately.

He also demanded a 4-hour debate for a proper discussion on the Covid-19 pandemic, stating in his letter referring the Business Advisory Committee meeting held on September 13, where it was mentioned that it is very important to have a discussion on the prevailing public health situation.

Some bills have been listed to be passed onto the Rajya Sabha on Wednesday, including the Institute of Teaching and Research in Ayurveda Bill, and the Salaries and Allowances of Ministers (Amendment) Bill.

While in the lower house of the Parliament, the Lok Sabha has listed 3 debatable bills for passage, which includes Farmers’ Produce Trade and Commerce (Promotion and Facilitation) Bill, the Farmers (Empowerment and Protection) Agreement on Price Assurance and Farm Services Bill, and the Banking Regulation (Amendment) Bill.

Opposition parties including Congress in Haryana and Punjab have raised their objections to these bills in view of the farmers’ protests going on against these new laws.

Congress made a statement last week stating that if the ordinance becomes law, all key financial intermediaries will come under the control of the Central Government, which will mean more centralization. Congress Party representatives stated that the party stands for decentralization and for empowering states. This statement was made regarding the Banking Regulation (Amendment) Bill and other ordinances.

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A 43-year-old Assam man who has cremated 400 Covid-19 victims says- ‘I am tired.’

Cremation isn’t an easy task. It is even more difficult, if it is done for those who have died due to Covid-19. The Forty-three-year-old Ramananda Sarkar knows it better than most. In the last five months, he has helped in the funeral of around 400 Covid-19 deaths in Assam’s largest city of Guwahati.

Sarkar, who works at the Ulubari crematorium in Guwahati said that he has been cremating Covid-19 patients since April and has performed nearly 400 cremations till Tuesday. Earlier, he was used to handle around 1-2 cases on a per day basis. Since the last month, the cases have increased to 10-12 cremations daily.

In the last few weeks, there has been evidence of an increase in Covid-19 cases in Assam.
According to district officials, over 400 cremations have been performed till date at Ulubari crematorium. This crematorium handled the bulk of the load of cremations, while some cases were transferred to the Bhootnath crematorium, which is another designated place for the funeral of Covid-19 patients.
According to health officials, although the official figure of deaths due to Covid-19 is 378, the number of patients who tested positive for the disease is above 500. There are many deaths which are due to comorbidity cases. The audit board doesn’t count them and those who tested positive because of the death of other Covid-19 patients.

In last few days, there were rumours that because of an increase in fatal incidents, the bodies of Covid-19 patients are lying within the morgue for days due to lack of sufficient manpower to dispose them.
Kamrup metro administration is additionally facing a difficult time in performing the last rites of Covid-19 dead bodies. Resources have been stretched to a limit and also the team is functioning overtime. This was stated by a neurosurgeon at GNRC Hospital, Guwahati, Dr Navanil Barua.

There have been cases of huge delays because of piling up of cases of deaths due to Covid. The number of deaths is still increasing, which will increase the waiting time for dead bodies of other Covid victims. So many bodies are not being handed over to relatives.

The district administration said that there was a problem because of laxity from private hospitals in informing DAB about deaths due to Covid.

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Kerala CM Vijayan asks to be prepared as ‘Covid-19 cases are likely to go up by next month’

Meravote Media

Pinarayi Vijayan- the Chief Minister of Kerala on Thursday warned the state of an expected rise in the growth rate of positivity for Covid-19. He said that he has been notified by the experts that the cases will rise sharply by the next month. It is advised not to lift the limitations of social distancing and lockdown at this point.

He said that the state’s purposeful surveillance has helped control the fatality rate in the past few months. However, this does not mean that the restrictions can now be lifted as the threat is still existing. “Some studies have pointed out that Covid-19 cases will peak by October. We should not let our guard down citing drop in daily cases. The reduced number is due to the lesser number of tests. Onam festivities led to a dip in tests.”- the CM said.

As warned by the experts, the state had expected the daily cases to go up to 10,000 in the last month. Although, the people were able to manage the situation and control the spread of the virus bringing down the number of daily cases. He added “Test positivity rate is above 8 now. We have to bring it down to 5. At least 50 percent of the total cases came up in last month. Though we managed to contain a massive spread, the threat remains.”

The Moving Growth Rate (MGR) for positivity in the state is said to be twice  the national average, according to some of the independent experts. The 30-day MGR for the state is 122%, however, the national average in August was about 64%.

There has been extensive criticism from people and ministers that many deaths have not been mentioned in the official list by the state government, to reflect a low fatality rate in the state. Experts suggest that the actual death toll might be more than double the official number of deaths as given by the government. At present, 316 Covid-19 deaths have been recorded by the government of Kerala.

This increment in the numbers is said to be a result of elevated testing rates which were 10,000-15,000 tests daily till July, and now have gone up to 50,000 per day.

As of this day, total positive cases in the state are 79,568 with 1,153 fresh cases being reported today. The number of recovered patients is 57,732, with the number of active cases being 21,516. Adding to the death toll of 316 were 10 more deaths reported today, in Kerala.

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N-95 masks most effective at restraining Covid-19 spread: Research

To reduce the novel coronavirus, N-95 masks have been found to be the most effective in keeping the virus at bay. But, as per the study by researchers, including Indian Space Research Organisation (ISRO), which suggests that any mask is better than no mask at preventing Covid-19.

The researchers noted that during coughing and sneezing airborne transmission by respiratory aerosol droplets produced is the supreme mode of spreading for infectious diseases such as Covid-19. Padmanabha Prasanna Simha, from ISRO, and Prasanna Simha Mohan Rao, from the Sri Jayadeva Institute of Cardiovascular Sciences and Research in Karnataka, experimentally visualised the flow fields of coughs under various common mouth covering scenarios.

According to the study published in the journal Physics of Fluids, N95 masks are found to be the most effective at reducing the horizontal spread of a cough. It has also been found that N95 masks reduced a cough’s initial velocity by up to a factor of 10, and limit its spread to between 0.1 and 0.25 meters, the researchers said.

An uncovered cough, in comparison, has the capability to travel up to three metres, but even a simple disposable mask has the capability to bring all the way down to 0.5 metres, they said.
Simha and Rao hoping that their research will put an end to the argument that regular cloth masks are ineffective, but it has also been emphasized by them that mask must continue to be used in addition to social distancing.

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Bihar polls may cost Rs 625 cr, one-fifth of funds for Covid-19 preparations

In the first Assembly elections to be held in Bihar amidst the Corona epidemic, Nitish government is likely to spend an estimated amount of Rs 625 crore, which is double the amount spent in the last state elections in 2015 and one-fifth of funds for Covid-19 preparations.

The state government will have to spend one-fifth of the total amount in the election of the bar to ensure security at booths for voters and polling personnel.

Talking about the last election, around Rs 270 crore was spent on the election at that time and instead of this, Rs 131.48% will be spent on the expenses of this year’s elections. The biggest reason for this is the corona epidemic. This time, in addition to purchasing PPE kits for six lakh polling personnel, security measures like gloves and masks will cost more.

At the same time, the Election Commission (ECI) is also considering the safety of the voters, including making a ballot outside the booth, where voters will be asked to stand far away while doing social distancing before casting their votes. At the same time, the need for buses, trucks, SUVs, and other vehicles will be much higher than in previous elections, in which the expenditure will be high.

The officer related to the election said that “This time the counting centers will be very large so that polling agents and polling personnel can maintain proper social distance during the counting process.”

According to sources, in order to maintain the safety norms during the elections, to increase the number of voters in each booth to 1000 or less, in addition to 72,727 booths, 33,797 auxiliary booths have been increased by 45%. Explain that there are a total of 243 assembly constituencies in Bihar. The state government will have to spend a lot of other expenses in such preparations.

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Oxford vaccine to begin phase 3 trial soon. Here’s all you need to know

As India continues to log the highest number of coronavirus cases daily in the world since August 8, there comes a ray of hope as government’s think-tank Niti Aayog has said that a vaccine for coronavirus will enter the third phase of clinical trials in India anytime now.

The vaccine which will be tested is the one developed by UK’s Oxford University, Niti Aayog chief VK Paul said media.

The clinical trial document of the Serum Institute — which is in charge of mass manufacturing the vaccine of Oxford University, currently dubbed “Covishield” — shows that 1,600 subjects will be tested at 17 hospitals across the country including AIIMS Delhi and Jodhpur. The trial will take seven months.

Meanwhile, the Chinese vaccine developed by Sinopharm is said to be available by December 2020 and will cost Rs 10,000 for two doses, as per a Global Times report. Australian Prime Minister has assured that the COVID19 vaccine will be made available for free for its citizens.

He said that the central government has reviewed these experimental coronavirus vaccine candidates. He said that potential coronavirus vaccines are making good progress. He also said that the outline of the Coronavirus vaccine administration and supply chain is ready.

In his Independence Day address to the nation from the ramparts of Red Fort, PM Modi had promised that the vaccine, once developed, will reach every Indian.

“Three vaccines are in different stages of testing. When scientists give the go-ahead, we are ready with a plan for production. How the vaccine will reach every Indian in the least amount of time – we have a roadmap ready for that,” the Prime Minister had said.

India’s other two indigenous vaccines which are undergoing human trials. These are COVXIN and ZyCoV-D. Covaxin is being developed by Bharat Biotech, Indian Council of Medical Research (ICMR), and National Institute of Virology, Pune. COVAXIN already completed phase 1 human trials in just one month. It had begun its Phase 2 human trials. Human trials of COVAXIN are going on in 12 sites across India. Zydus Cadila is developing the other potential COVID vaccine ZyCoV-D. Meanwhile, the Pune-based Serum Institute is also beginning the phase 3 human trials of Oxford-AstraZeneca’s coronavirus candidate.

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Russia registers the first Covid vaccine- hails it a Sputnik moment

The world witnessed Russia registering its first Coronavirus vaccine. Putin stated in a meeting that the vaccine has proven to be effective in tests to counter Covid 19. Russian government led by Putun hailed this as a landmark development as the registration of the vaccine was done with less than two months in human trials. Russia vouched it as a moment to prove the scientific finesse of the country.

This step of speedy registration has raised some concerns from certain sections of observers as the final trials are yet to be completed. Sistema, a Russian conglomerate expects to put the vaccine into mass production by the year end. In the coming weeks, the health workers treating the Covid patients across Russia would be given the chance to volunteer to be vaccinated. An interesting angle to this story is that president Putin said that his daughter has been given a shot of the vaccine.

Whether this statement was issued to build an amount of trust factor among Russians remains to be seen. Mass inoculation will follow after the regulatory approvals which doesn’t seem to be a barrier in the present scenario which may very well be a Russian moment. Head of Russian Sovereign wealth fund, Kirill Dmitriev commented that this vaccine development is a Sputnik moment in Russian history. He compared it to the 1957 launch of Sputnik I,the world’s first satellite by USSR. In order to take this message further around the world, the vaccine would be marketed under the name of Sputnik V.

It remains to be seen how the vaccine goes through WHO pre qualifications and mandated requirements under TRIPS.

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Former President Pranab Mukherjee tests positive for Covid-19

  • This afternoon, former President Pranab Mukherjee revealed that he has tested positive for coronavirus and requested people who came into contact with him recently to self-isolate by sharing a post on twitter.

”I found myself positive while I went for a routine check-up”, said Mukherjee.

“On a visit to the hospital for a separate procedure, I have tested positive for COVID19 today. I request the people who came in contact with me in the last week, to please self-isolate and get tested for COVID-19,” tweeted Mukherjee.

As news spread, leaders, cutting across party lines, wished Mukherjee a quick recovery.
”Please take care sir. We are praying for your speedy recovery and good health”, tweeted Arvind Kejriwal, Chief minister of Delhi.
”I pray for the well-being and speedy recovery of Shri Pranab Mukherjee. I am confident he will be successful in recovering from the virus quickly. Wishing him strength and good health”, tweeted Piyush Goyal, Minister of Railways and Minister of Commerce and Industry.

The former President, 84, had cancelled all his engagements and stopped going out for public functions the last few months. In the wake of raging coronavirus epidemic, the government had asked all senior citizens (above the age of 65) to stay at home.

Mukherjee, who served as the 13th President of India between 2012 to 2017, was invited for the at home programme at Rashtrapati Bhavan, which he will not be attending in the wake of this development.

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Concerns and hope till the Covid vaccine arrives

The White house Coronavirus advisor and Director of the National Institute for Allergy and Infectious Diseases, Dr. Anthony Fauci has been known for his comments on the current pandemic raging throughout the world. He has time and again stressed on the need to enhance the public health measures, even at times pointing out the fallacies in how the USA has been dealing with the COVID 19. His comments have more than often have been diametrically opposite to the statements made by POTUS Trump in his various White House press conferences. In the earlier weeks, he had raised concerns that the pandemic situation could get worsened if the norms of social distancing are not followed strictly.

Recently, in a webinar, he has asserted that the efficacy of a COVID vaccine may be in the range of 50-60 %. He also added that the chances of the vaccine being 98% effective are not that great. He further stated that the studies of Moderna Inc COVID vaccine could very well generate definitive data by November or December of 2020. That the Coronavirus could not be completely eradicated, and that the prevalence of its infection can be reduced has been stated earlier by him.

Amid various voluntary trials and vaccine development steps taken around the world, India has been under global limelight as it is the trusted producer of a large number of vaccines needed around the world. This has been affirmed by Dr. Fauci. At one of the conferences, he had mentioned that the world would need a billion COVID vaccines by the end of 2021. This pandemic has been described by various experts including Dr. Fauci as the perfect storm whose end is not in the sight. That it has a respiratory base and is very effective in the human to human transmission makes the disease a nightmare scenario for the public health officials, epidemiologists, and other specialized disease experts. Another concerning feature of this virus is that it jumps species.

Experts like Dr. Swamy Swaminathan of WHO had made a point on the importance of the role of international cooperation through WHO to make an equitable distribution of the COVID vaccine possible. Leading public health officials including Dr. Swaminathan and Dr. Fauci are worried regarding the COVID as it has an unprecedented broad spectrum and range. Almost 20 to 49% of people infected people have no symptoms. Some have mild symptoms for around two weeks, then have the post-viral syndrome, while many others need hospitalization, support of Oxygen, Intensive care unit treatment with many even dying.

Another problem which the world is trying to avoid under the aegis of World health organization is the stashing away of the developed vaccines by the rich countries which happened in the 2009 H1N1 pandemic. This can be avoided if the arrangement of GAVI can be used in its all true intentions and purposes. GAVI – Global alliance for vaccines and immunizations is a public-private partnership in the public health domain with connections and inputs from WHO, World Bank, and UNICEF. It has been instrumental in setting a deal between the Indian Pharmaceutical company-Serum Institute and the British-Swedish firm – Astra Zeneca using funding from Gates Foundation for manufacturing of 100 million units of COVID vaccine.

There are some important stages through which the vaccines come from the stage of inception to final availability in the public space. There are clinical human trials (three phases generally), standardization of the dosage amount for the particular target population, then streamlining of the production operations and then production and distribution. As of now in the Indian context, the Serum Institute is being looked at as the main provider of the vaccine. Until the time vaccine becomes available in the public domain, it is in best interests of the public to follow what is being repeatedly told by the experts around the world like Dr. Fauci and Dr. Swaminathan, i.e. to follow social distancing, wash hands, maintain a certain level of hygiene and to wear the mask while stepping out.