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Serum Institute gets DCGI nod to resume Oxford COVID-19 vaccine trial in India

Expert panel recommends Bharat Biotech’s Covaxin for restricted emergency use
Representational/File image

New Delhi (NVI): The Drugs Controller General of India (DCGI) gave permission to Pune-based Serum Institute of India (SII) to resume its phase two and three clinical trials for the Oxford COVID-19 vaccine in the country.

This development comes after the pharmaceutical company submitted the recommendations of the Data Safety Monitoring Board (DSMB), UK and DSMB India and requested permission to restart enrolment in the subject clinical trial.

In a letter to SII, DCGI VG Somani, said that the institute’s reply has been carefully examined as also the recommendations of the DSMB in India and in UK.

“You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the Data Safety Monitoring Board (DSMB), India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up,” the letter read.

The DCGI has also asked institute to submit the details of the medication used as per protocol for the management of the adverse events.

In addition to this, Pune-based firm submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale.

AstraZeneca, had earlier paused the ongoing trial of COVID-19 vaccine as a volunteer had developed an unexplained illness.

Reportedly, the vaccine trial was put on hold in the US, Brazil and the United Kingdom but the trials have now resumed in the UK.

On September 11, the DCGI directed Serum Institute to suspend any new recruitment in the phase 2 and 3 clinical trial of the Oxford COVID-19 vaccine candidate till further order.

Earlier in August, the Serum Institute of India, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, was granted permission by India’s top drugs regulator to conduct a phase 2 and 3 clinical trial of COVID-19 vaccine at various clinical trial sites in India to determine its safety and immune response.

-RJV

India’s COVID tally crosses 5 million, death toll at 82,066

corona
(File/Representational image)

New Delhi (NVI): India coronavirus tally has crossed the five million mark and stands at 50,20,360, with a single-day spike of 90,123 new cases in last 24 hours, Union Health Ministry said.

The country’s death toll has reached 82,066 with 1,290 fatalities reported during this period.

Notably, the number of active cases stands at 9,95,933, while 39,42,361 patients have been cured and discharged from the hospitals across the country.

In worst-hit Maharashtra, the COVID-19 cases climbed to 10,97,856, followed by Andhra Pradesh with 5,83,925 cases, and Tamil Nadu with 5,14,208 cases.

The other worst affected states in the country are Karnataka (4,75,265), Uttar Pradesh (3,24,036) and Delhi (2,25,796).

Maharashtra has also reported the highest number of death toll at 30,409 followed by 8,502 deaths in Tamil Nadu.

The death toll in the national capital surpassed to 4,806, while 1,91,203 patients have recovered so far, the healthy ministry data shows.

According to the Indian Council Medical Research (ICMR), 5,94,29,115 samples tested up to 15th September for COVID-19. Of these, 11,16,842 samples tested yesterday.

Meanwhile, the government yesterday said that the number of recoveries in India was amongst the highest in the world and the country learnt from the experience of nations that suffered high mortalities to avoid a huge peak in terms of deaths.

-RJV

 

‘Winter is coming’, but Indian troops ready for long haul in Ladakh: Rajnath in LS

New Delhi (NVI): In response to Chinese actions at LAC and Beijing’s concerns over the well being of Indian troops in Ladakh, Defence Minister Rajnath Singh today delivered a strong message, saying that the Indian troops have been provided with all equipment, weapons and ammunition to survive icy heights and tough terrain in the upcoming winters.

While making a statement in the Lok Sabha today, the Defence Minister said that the Indian troops deployed at LAC in Ladakh are being provided with suitable clothing and equipment to deal with any weather condition, since they have survived such weather for years in Kargil and Siachin.

“The determination of our troops is praiseworthy.  They are capable of serving at forbidding altitudes with scarce oxygen and in extremely cold temperatures, something that they have effortlessly done over the last many years on Siachen, and Kargil,” Rajnath told the parliament.

The Defence Minister’s statement on the preparedness of Indian troops at LAC, with the approaching winter, come days after an editorial by Chinese State-run Global Times claimed that Indian soldiers will face the threat of freezing temperatures and uncontrollable epidemic (Covid-19).

The Chinese State media had further claimed that Indian troops’ logistics are incomparable to that of the PLA.

“In high-altitude areas, India does not have the ability to make a large number of troops over the winter, which means many Indian soldiers will face the threat of freezing temperature and the uncontrollable epidemic. Indian troops’ logistics are incomparable to that of the Chinese People’s Liberation Army (PLA),” The Global Times said in the editorial published on September 10.

While responding to China’s ‘concerns’ Rajnath said, “I can assure you that the morale and motivation of our Armed Forces is very high. The reassuring visit by our PM has ensured that our commanders and soldiers understand that the entire nation stands behind them in support of the just cause of defending our territorial integrity. They are accordingly being provisioned with suitable clothing, habitat and the required defence wherewithal.”

“I will not hesitate to share with this august House that we are facing a challenge in Ladakh and I urge the House to pass a resolution in support of our Armed Forces who have been defending our motherland at great heights and most inclement weather conditions in Ladakh for our safety and security,” he added.

“This is a time when this august House has to come together and reiterate confidence and faith in the valour of the brave armed forces and support them in the mission that they have undertaken to protect the territorial integrity of our motherland,” Rajnath said while concluding his statement on Ladakh in the parliament.

Amid an escalating border row with China, more than 50,000 Indian troops are likely to remain stationed through winter months to deal with any provocation by China’s PLA. With no end in sight to the tense stand-off in Ladakh, Indian troops have also ramped up efforts to boost border infrastructure to deal with any situation.

Infiltration bid foiled in J&K’s Bandipora; US-made rifle, ammo recovered

Abid Bashir

Srinagar (NVI): An infiltration bid was foiled by the Indian Army in Gurez sector of north Kashmir’s Bandipora district and a large quantity of arms and ammunition was recovered during the operation, including a US-made assault rifle.

Defence sources that an operation was launched after the suspicious movement was noticed at Budaab sector in Gurez on September 14. They said that the group was challenged by alert troops last evening.

“Contact was established and the suspected militants were fired upon by security forces. Aggressive and timely action by forces foiled an infiltration bid as militants went back leaving behind arms and ammunition,” they said.

During the joint search operation, warlike stores were recovered including 1 US made assault rifle with 4 magazines and 135 rounds, 3 pistols with 5 magazines and 120 rounds. 1 GPS, Cortex (4m), 4 rucksacks, defence sources said, adding that a search operation is in progress in the area.

-ARK

1,329 fresh Covid cases, 19 deaths take J&K’s tally to 56,654

Over 3,200 cops COVID positive in J&K and 15 succumbed to virus
File photo

Abid Bashir

Srinagar (NVI): Jammu and Kashmir today recorded 1,329 fresh Covid-19 cases, while 19 people lost their lives due to the deadly virus in the Union Territory, taking the overall tally to 56,654.

The Covid-19 death toll in the UT has climbed to 914.

Of the total 56,654 cases, 37,688 are from Kashmir and 18,966 from Jammu division. Officials said that among 1,329 new cases, 558 belong to Kashmir division while 741 are from Jammu division, adding that the total number of positive cases in Kashmir has reached 37,688 including 28,678 recoveries and 740 deaths.

On the other hand, the total number of positive cases in Jammu division has reached to 18,966 including 8,384 recoveries and 174 deaths.

The UT health officials said that total number of active cases in J&K is 18,678 including 8,270 from Kashmir division and 10,408 from Jammu division.

With 681 more recoveries, the tally of total recoveries in the UT has reached 37,062 which is 65.41 percent of the total cases which was over 78 per cent few day before.

Interestingly, first time since Covid-19 outbreak, active cases have reached over 18,500 in J&K and active cases in Jammu division are more than recovered cases.

“Cases tested positive in J&K include 148 from Srinagar, 1277 from Budgam, 20 from Baramulla, 70 from Pulwama, 57 from Anantnag, 43 from Kupwara, 38 from Bandipora, 15 from Kulgam, 59 from Ganderbal and 11 from Shopian in Kashmir division while as 837 from Jammu division include 254 from Jammu, 51 from Udhampur, 105 from Rajouri, 62 from Kathua, 31 from Samba, 38 from Poonch, 26 from Ramban, 114 from Doda, 15 from Reasi and 45 from Kishtwar,” as per the daily Covid bulletin.

Meanwhile, 19 persons who were tested positive for Covid-19 have died which include 5 from Kashmir division and 14 from Jammu division. As per media bulletin, patients who have died include 3 from Srinagar and one each from Baramulla and Kupwara in Kashmir division while 14 from Jammu division include seven from Jammu district, two each from Udhampur, Ramban and Doda and one from Kathua.

As per the daily bulletin, 5,27,802 persons in J&K are under observation while 34,530 persons have been kept under home quarantine. Besides that, 18,678 persons are in isolation.

Apart from that, 4,13,382 persons have completed surveillance period and 60,298 persons are under home surveillance. So far, results of 12,70,310 samples are available.

Out of 12,70,310 total samples, 12,13,656 have tested negative while 56,654 have tested positive. Among positive cases, 18,678 are active and 37,688 persons have recovered.

-ARK

Army Major, 2 soldiers injured in Pak firing along LoC in J&K’s Rajouri

Ceasefire
Representational image

Abid Bashir

Srinagar (NVI): An Indian Army officer and two soldiers were injured in a fresh ceasefire violation (CFV) by Pakistan along the Line of Control (LoC) in Malla sub-sector in Sunderbani area of Rajouri district in J&K this evening, officials said.

Official sources told NVI that Pakistani army resorted to intense shelling with small arms and mortar shells in which an Army officer of the rank of Major and two soldiers were injured.

“Pakistani army carried out target fire on many army posts in Sunderbani area in which one army major, one subedar accompanying him and one jawan received injuries,” they said.

The injured personnel are under treatment with one of them is having serious injuries, they said. Seven to eight forward posts of Indian army came under heavy fire from Pakistani side as firing lasted for over two hours from 04:40 PM onwards today, they added.

-ARK

ITEC celebrates its 56th anniversary

New Delhi (NVI): The Indian Technical and Economic Cooperation (ITEC), a flagship programme of the Indian government to provide development assistance to developing countries across the globe, is celebrating 56 years of knowledge sharing and capacity building.

Many young professionals have benefitted from various ITEC programs over the years and these training programs provide an opportunity to share best practices that benefit both the countries.

On the occasion, ITEC has wished all its partners across the global south and 2,00,000 + strong alumni family on Twitter. September 15 is celebrated as ITEC Day every year.

External Affairs Minister S Jaishankar also tweeted: “@ITECnetwork turns 56! Leads the way on our growing development partnerships. Value this pillar of our foreign policy.”

The Indian embassies in countries like Turkey, Sudan, Oman, Bangladesh and Hungary shared video messages by ITEC alumni and press coverages on events to celebrate the program’s 56 years.

Instituted in 1964, ITEC provides more than 10 thousand training slots every year to more than 160 partner countries for training courses in various areas like Accounts, Audit, Management, SME, Rural Development, Parliamentary Affairs etc.

 -ARK

BSF foils infiltration bid on International Border in J&K’s Samba

LoC

Abid Bashir

Srinagar (NVI): A major infiltration bid along the International Border in Samba district of Jammu and Kashmir was foiled by the Border Security Force (BSF) today as it engaged the infiltrators first and then forced them to go back to the Pakistani side.

A BSF spokesman in a statement issued here said that on the intervening night of 14-15 September, alert troops of BSF foiled an infiltration bid from Pakistan side in Samba sector of J&K.

“Movement of a group of five militants was noticed in Pakistan side of International Boundary of Samba sector which was tracked by alert BSF troops. At about 12:30 hours (in midnight), the group of heavily armed five militants were seen by alert BSF troops close to International Boundary in Pakistan side where they reached taking advantage of undulating ground and thick wild growth,” the BSF spokesman said.

He said that the militants took refuge in a place having dense wild growth. “All nearby BSF duty points also alerted, BSF troops challenged them to stop on which they fired on BSF party with heavy volume of fire. BSF alert troops in self defence fired on the infiltrating militants in a coordinated effective fire and foiled a possible infiltration bid, an attempt of armed militants from Pakistan side helped by Pakistani rangers,” said the BSF spokesman.

He said that the area was illuminated with the help of para bomb and BSF troops saw the militants fleeing towards Pakistan side. “The area was searched but nothing was recovered as militants could not cross the IB. Strong protest note is being lodged with Pakistan Rangers for their help in facilitating militants in infiltrating towards Indian side,” BSF spokesman added.

-ARK

LS passes bill to cut MPs’ salaries by 30%

New Delhi (NVI): A bill to reduce the salaries of MPs by 30 per cent was today passed in the Lok Sabha in the wake of Covid-19 pandemic and exigencies arising out of it.

The Salary, Allowances and Pension of Members of Parliament (Amendment) Bill, 2020 was introduced in the Lower House yesterday by Union Parliamentary Affairs Minister Pralhad Joshi.

Once it becomes a law, it will replace the Salary, Allowances And Pension of Members of Parliament (Amendment) Ordinance, 2020 which was brought in April this year.

The ordinance was cleared by the Cabinet on April 6 and promulgated the next day.

Parliamentary Affairs Minister Joshi, while responding at end of the debate said that the proposal to suspend MPLADS funds is temporary and for only two years.

However, many Opposition members expressed reservation on the move, saying that the suspension of funds related to MPLADS or Members of Parliament Local Area Development Scheme could translate to causing impediments in ground level work in their constituency.

-ARK

Doval walks out of SCO NSA meet after Pakistan displays new political map

New Delhi (NVI): In yet another gimmick to provoke India, Pakistan today deliberately displayed its new political map at the meeting of National Security Advisers of SCO member states, in blatant disregard to the advisory by the host against it and in violation of the norms of the meeting. 

NSA Ajit Doval, who was representing India at the virtual meeting, lodged protest against this childish stunt of Pakistan and walked out of the meeting.

“At the meeting of the National Security Advisers (NSAs) of member states of the Shanghai Cooperation Organization (SCO), hosted by the Chair of the SCO (Russia), the Pakistani NSA deliberately projected a fictitious map that Pakistan has recently been propagating, “MEA spokesman Anurag Srivastava said in a statement.

“This was in blatant disregard to the advisory by the host against it and in violation of the norms of the meeting. After consultation with the host, the Indian side left the meeting in protest at that juncture,” Srivastava said.

As was to be expected, Pakistan then went on to present a misleading view of this meeting, the MEA spokesman added.

Pakistan NSA Yusuf Moeed was seen attending the virtual meet hosted by Russia, with the controversial new map of Pakistan at the wall behind him, which shows Indian territories as their own.

NSA Doval lodged a strong protest over this action by Pakistan and walked out of the meeting. Pakistan has earlier also resorted to such immature actions to provoke India at international platforms, either through its statements on Kashmir or displaying the amended map.

-ARK

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