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How the Sputnik-V vaccine received emergency use approval in India

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Russia’s Sputnik-V vaccine has received emergency use approval from the Subject Expert Committee of the Central Drugs Standard Control Organisation and now it awaits the final approval from the Drugs Controller General of India. Calls were being made to grant approval for the same citing the second wave in India.

The approval today has suddenly given some people cause to fall prey to their own false notions about the whole process. Some have decided it is a moment to pay tribute to the renowned intellect of Rahul Gandhi.

Others believe the approval has come forth due to the voices raised by the opposition.

In reality, the emergency use approval for Sputnik-V today is another step in a process that began as early as September 2020 when Dr. Reddy’s said that they were looking to begin late-stage Indian clinical trials for the vaccine within the next few weeks. This has been pointed out by users on social media.

“We want to get to the first step – which is the commencement of the clinical trials by getting the necessary approvals from the Indian regulators – within the next few weeks,” Deepal Sapra, CEO for API and pharmaceutical services at Dr. Reddy’s (DRL), had told Reuters in September.

It was reported that the trials were part of a deal between Russian Direct Investment Fund (RDIF) and Dr. Reddy’s which involved the Indian firm conducting the Phase 3 trials in India and pursue local regulatory approvals. “I think it’s going to be several months before we accomplish all the steps in the process,” Sapra had said back then.

Dr. Reddy’s received the approval to conduct the Phase 3 trials from the Drugs Control General of India (DCGI) in January 2021. It was after the Data and Safety Monitoring Board (DSMB) reviewed the safety data of the Phase 2 clinical trials and recommended the next phase of trials.

G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories had said, “This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase 3 study within this month and will continue to fast-track our efforts to bringing in a safe and efficacious vaccine for the Indian population”.

On the 19th of February, Dr. Reddy’s sought emergency use approval for the Sputnik-V vaccine with Phase 3 trials due to be completed on the 21st of February. It had said then that the safety profile of the phase 2 study and the interim data of the ongoing Phase 3 trials would be presented.

It was reported on the 16th of March that the Phase 3 trials had been completed and results were due in April. The phase involved 1500 participants and was randomised, double-blind, parallel-group, and placebo-controlled study in India.

On the 2nd of April, the authorities sought more data for emergency use approval. A source said, “No approval was given to Sputnik V on Thursday. Some queries have been asked on safety, efficacy, and logistics, which the firm will have answers to at the next meeting.” “Current storage temperature requirement is at minus 18 degrees Celsius. We are working on other storage conditions as well,” a spokesperson for DRL had said.

Ten days later, on the 12th of April, the SEC met today to discuss the emergency use approval for the Sputnik-V Vaccine and the clarifications that were provided. Following the meeting, approval for the same was granted. And now, it awaits the DGCI’s final approval.

Therefore, while politically motivated individuals may be inclined to credit their favoured opposition leaders for the development, the fact of the matter is that it is only the logical step of a process that began September last year.

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ENTERTAINMENT

(Viral) Here’s Come The Party Owl | Internet Trending Meme 2021

Internet is full of fun, specially if it’s about the ‘memes’. Recent snappy video of an Owl is getting viral on web day by day. An Owl who is bored and fed up of lockdown, is willing to have fun outside. When suddenly hears party sound, his reaction is awesome!.

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Internet is full of fun, specially if it’s about the ‘memes’. Recent snappy video of an Owl is getting viral on web day by day. An Owl who is bored and fed up of lockdown, is willing to have fun outside. When suddenly hears party sound, his reaction is awesome!.

Watch the star Owl reaction below and share with your friends:

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ENTERTAINMENT

Woman Gives Birth To 9 Babies | Created New World Record

It’s a new world record has been set for the most number of birth given at a time, with a shocking number of 9 in total.

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A Malian woman gave birth to nine babies on Tuesday – two more than doctors had detected inside her crowded womb – joining a small pantheon of mothers of nonuplets.

The pregnancy of Halima Cisse, 25, has fascinated the West African nation and attracted the attention of its leaders. When doctors in March said Cisse needed specialist care, authorities flew her to Morocco, where she gave birth.

“The newborns (five girls and four boys) and the mother are all doing well,” Mali’s health minister, Fanta Siby, said in a statement.

Cisse was expected to give birth to seven babies, according to ultrasounds conducted in Morocco and Mali that missed two of the siblings. All were delivered by cesarean section.

Nonuplets are extremely rare. Medical complications in multiple births of this kind often mean that some of the babies do not reach full term.

It’s a new world record has been set for the most number of birth given at a time, with a shocking number of 9 in total.

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The new mother had no idea she was pregnant and gave birth at just 29 weeks

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Lavinia Mounga boarded a Delta flight to Honolulu, expecting to have a relaxing family vacation. Hours later, Mounga would land in Hawaii with a newborn baby boy, named Raymond, in her arms.

The new mother had no idea she was pregnant and gave birth at just 29 weeks, according to The Associated Press

On Wednesday, about halfway through the flight from Salt Lake City, a medical emergency was announced by the flight’s captain and four passengers ran to Mounga’s aid.

Hawaii Pacific Health family medicine physician Dale Glenn and North Kansas City Hospital neonatal intensive care unit nurses Lani Bamfield, Amanda Beeding, and Mimi Ho helped Mounga deliver her son and monitored the baby’s health for several hours.

Glenn told USA TODAY that an infant’s first minute of life is vital and that without the intervention of the three nurses, the baby might not have survived. While in labor, Glenn said, Mounga passed out, most likely from shock. 

“Myself and the nurses’ survival mode kicked in; we had to create an ICU unit within an airline,” Glenn said. “Plus, we didn’t just have one patient, we had two.”

Lavinia Mounga and Dr. Dale Glenn posing after Mounga gave birth aboard a Delta flight to Hawaii.

The impromptu medical team was able to create makeshift medical equipment, in part thanks to Glenn’s wilderness training. Glenn said they used multiple shoelaces to cut the baby’s umbilical cord, and an Apple Watch was used to monitor the baby’s heart rate. To keep the premature baby warm, bottles of water were microwaved, and the nurses wrapped him in plastic. 

Glenn said the passengers were “surprisingly calm” and offered their own diapers and blankets to help the mother and son. Glenn also applauded Mounga’s strength; he said she was up and walking minutes after her delivery.

A Delta spokesperson told USA TODAY that all crews are “well-trained” to manage on-board medical scenarios. 

“Every aircraft is equipped with medical equipment and crews have access to expert counsel during the flight when an issue occurs,” Delta spokesman Anthony Black told USA TODAY.

The four passengers worked to keep Mounga and baby Raymond safe for three hours until the plane landed. Once they arrived in Honolulu, the mother and baby were taken to Kapiolani Medical Center for Women & Children.

In a TikTok video shared by Julia Hansen, passengers can be seen cheering and congratulating Mounga as she leaves the plane. The video has garnered more than 13 million views.

Hansen and a friend she was flying with, Siearra Rowlan, told The Washington Post the emergency initially caused a commotion, but other passengers were “casual” about it by the end of the flight.

“Everyone just kind of got up, got their carry-on and left,” Hansen said of the scene after Mounga and her son were escorted off first.

On Friday, Glenn, Bamfield, Beeding and Ho were reunited with Mounga and her son at the medical center.

“(Mounga) is an incredible person. She got on this flight for a vacation and instantly became a mother. But she’s handling it so positively, it’s great to see,” Glenn said.

Mounga has since been discharged, while her son, Raymond, remained in the neonatal unit.

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