Coronavirus vaccine news highlights: We don't know for how long vaccine is going to be effective, says ICMR

AIIMS Delhi Director, Dr Randeep Guleria said vaccines got approval after critical analysis by experts “It's important to understand that when we consider any vaccine, safety is paramount and therefore vaccine goes through various stages to make sure it's safe, and then only we come to human trials. All data is critically looked at by experts after which vaccine is approved,” said Dr Randeep Guleria.

. Each batch of the vaccine consists of 50,000 doses, and the ministry has announced that the first group to receive it will be medical workers.

. Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

. Drugs Controller General of India VG Somani on January 3 said that Covid-19 vaccines are 110% safe. Somani also cleared the air over rumours being spread regarding vaccines.

“We will never approve anything if there is slightest of safety concern. Vaccines are 110 % safe. Some side effects like mild fever, pain and allergy are common for every vaccine. It (that people may get impotent) is absolute rubbish,” said DCGI Somani.

Covid-19 vaccines of Serum Institute of India and Bharat Biotech have been granted permission for restricted use in an emergency situation.

. Chief Executive Adar Poonawalla said in an interview after the shot was approved for emergency use in the world's second-most populous country, that exports might be possible after supplying the Indian government with an initial 100 million doses.

. Drugs Controller General of India VG Somani on January 03 informed that Covid-19 vaccines of Serum Institute of India and Bharat Biotech have been granted permission for restricted use in emergency situation.

. Union Minister Hardeep Singh Puri also took a swipe at the opposition leaders, saying they are on a quest for permanent political marginalisation. His dig, however, drew a sharp retort from Congress leader Jairam Ramesh who compared him with Nazi propagandists.

. Drugs Controller General of India (DCGI) gives licensing permission to Bharat Biotech to manufacture COVAXIN.

Bharat Biotech asked to submit updated safety, efficacy & immunogenicity data from the ongoing Phase I, II & Ill clinical trials till the completion of trials.

. "We don't know for how long vaccine is going to effective, we don't know how much of the population we'll have to vaccinate to break the virus transmission. What we know is that we've been able to control the pandemic in the country by following COVID appropriate behaviour," said DG, ICMR.

"I am of the opinion that masks will probably be the last to go & probably may never even go," he said.

(ANI)

. The domestic logistics sector is expected to continue at the core of the next stage of the battle against the virus in 2021 even as some easing in freight charges and container shortage, which hit the exports in the last quarter of the previous year, is also expected during the year, experts have said.

India's $215 billion logistics sector is one of the largest globally and has been growing at a CAGR of 10.5 per cent, according to a recent report.

The sector was a key player in the movement of essentials and medicines supplies during the nearly two-month long complete lockdown to curb spread of the pandemic last year.

"For the logistics sector, the year (2020) has been a busy one! More so during the lockdown, when the sector emerged as the key player in prioritising the shipments of essentials and medical goods. As the vaccines get rolled out – hopefully in the next few months, logistics will again be at the core of the next stage of the battle against the virus in 2021," DHL Express Senior Vice President and MD R S Subramanian said.

(PTI)

. "Disgraceful for anyone to politicise such a critical issue. Shashi Tharoor, Akhilesh Yadav & Jairam Ramesh don't try to discredit well laid out science-backed protocols followed for approving Covid-19 vaccines. Wake up & realise you are only discrediting yourselves !" tweeted Union Health minister Harsh Vardhan.

. Union Minister Hardeep Singh Puri hit back at Tharoor and Ramesh for questioning the efficacy of the vaccines.

. The Drugs Controller General of India (DCGI) has approved conducting phase III trials of the country's first DNA vaccine candidate against COVID-19 being developed by Zydus Cadila, the Department of Biotechnology said on Sunday.

The vaccine candidate has been supported by the National Biopharma Mission (NBM) under the aegis of Biotechnology Industry Research Assistance Council (BIRAC), a PSU under the DBT.

"The nation's first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by M/s Zydus Cadila, has been approved by Drugs Controller General of India (DCGI), for conduct of the Phase III clinical trials," the DBT said.

(PTI)

. India's drugs regulator Sunday approved Oxford-AstraZeneca’s Covishield, manufactured in India by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

. The Subject Expert Committee (SEC) of CDSCO approved emergency use of Serum Institute of India's Covishield and Bharat Biotech's Covaxin today.

. "A momentous achievement for India! DCGI has granted approval to COVID vaccines of @SerumInstIndia and @BharatBiotech. I salute our very talented and hardworking scientists for making India proud. Congratulations to PM @narendramodi ji for striving towards a COVID free India," Amit Shah said.

. "We heartily thank our scientists, doctors, medical staff, security personnel and all Corona warriors who dedicatedly served humanity during these testing times. Nation will always remain grateful to them for their selfless service towards mankind," tweets Amit Shah.

. Saudi Arabia on Sunday announced the reopening of borders and the resumption of international flights after a two-week suspension aimed to stem the spread of a new Covid-19 strain.

Last month Saudi Arabia was one of the first Gulf countries to launch a massive vaccination campaign using the Pfizer-BioNTech jab. ( AFP )

. MP Narottam Mishra attacked SP Chief Akhilesh Yadav on the latter's comments about not getting vaccinated.

"We can't even call him a misled youth. When he never listened to his uncle or father, why would he listen to the country? This is a policy of appeasement. It's not good to spread rumours about vaccine," the MP told ANI .

. Union Health Minister Dr Harsh Vardhan called the vaccine approvals a "watershed moment in India’s famed battle against Covid-19 under leadership of PM Modi".

"Our wait for the vaccine is over with Covishield from Serum Institue of India and Covaxin from Bharat Biotech approved for emergency use in India," the minister said. ( ANI )

. “The approval of Covaxin for emergency use is a giant leap for innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India," DrKrishna Ella, Bharat Biotech's Chairman and Managing Director has said, according to reports.

"While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist,” Dr Ella said.

. Delhi Health Minister Satyendar Jain has said that in the first phase, healthcare workers and frontline workers will be vaccinated.

"There are three lakh healthcare workers and six lakh frontline workers in Delhi who will be administered with the Covid-19 vaccine," the minister said.

Jain has announced yesterday that citizens of Delhi will get free vaccinations once it arrives and that the government has prepared for the same.

. Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for restricted use of Bharat Biotech's Covid-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.

Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the issue of granting authorisation to the vaccine use needs to be taken carefully as no country has dispensed with the mandatory phase 3 trials and verification of data. ( PTI )

. TheWorld Health Organization has welcomedIndia's decision to giveemergency use authorization to Covid-19 vaccines,Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region, said.

"This decision taken today by India will help intensify and strengthen the fight against Covid-19 pandemic in the region. The use of the vaccine in prioritised populations, along with the continued implementation of other public health measures and community participation will be important in reducing the impact of Covid-19," she said.

. Cadila was given permission to conduct Phase-III clinical trial in 26000 Indian participantsrecommended by the Subject Expert Committee.

Cadila Healthcare has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. Interim data suggestthat the vaccine is safe and immunogenic with three doses when administered intradermally.

. DCGI CG Somani has said that the body would never approve anything if there is slightest of safety concern.

"The vaccines are 100 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine. It (people may get impotent) is absolute rubbish," he said. ( ANI )

. PM Narendra Modi took to Twitter to express gratitude to nation's scientists and innovators. "It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion," PM Modi said in a tweet.

. Bharat Biotech has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters, DCGI said in a press release.

All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approximately 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.

. Bharat Biotech's vaccine candidate Covaxin has received DCGI's approval for restricted usage in emergency situations in India.The indigenous vaccine is being manufactured by Bharat Biotech in collaboration with ICMR and National Institute of Virology in Pune.

This comes a day after Serum Institute of India's vaccine candidate got the approval for emergency use.

. The Drug Controller General of India(DCGI) will brief media at 11 am on Covid-19 vaccine.

The DCGI heads the Central Drugs Standard Control Organization and approveslicences for drugs in India. It is under the Union Ministry of Health and Family Welfare. DrVG Somani is the current DCGI.

. Bharat Biotech has successfully recruited 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of its Covid-19 vaccine Covaxin across multiple sites in India, it said.

The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the countrys first and only Phase III efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India, a press release from the vaccine maker said on Saturday night. ( PTI )

. Following accounts of potential allergies to the Covid-19 vaccines produced by Pfizer-BioNTech and Moderna, scientists have outlines steps on safely receiving the second dose of the therapeutic in individuals who develop a reaction to their first dose, in a study published in the Journal of Allergy and Clinical Immunology.

. India's drugs regulator is likely to approve administering two doses of the AstraZeneca/Oxford vaccine and another locally-developed one by Bharat Biotech, each four weeks apart, two sources with knowledge of the matter told Reuters on Saturday.

. Union Health Minister Dr Harsh Vardhan has said that the vaccination drive has been based on election process, "planned down to the booth level".

According to ANI , the minister also informed that over 57,000 participants across 719 districts have completed trainingand 96,000 vaccinators have been trained so far.

. Samajwadi Party president Akhilesh Yadav on Saturday termed the anti-Covid vaccine to be rolled out in the country a "vaccine of the BJP" and said he would not take the shot, prompting a sharp reaction not only from the ruling party but also from NC vice-president Omar Abdullah.

While the ruling BJP accused Yadav of "insulting" doctors and scientists of the country, Abdullah said vaccines “don't belong to any political party, but humanity”.

Hours after terming the anti-Covid vaccine as a “vaccine of the BJP”, Yadav said in a tweet that he had full faith in scientists but not in the “taali and thali wali unscientific thinking of the BJP”. (PTI)

. The USCenters for Disease Control and Prevention said it had administered 4,225,756 first doses of Covid-19 vaccines in the country as of Saturday morning and distributed 13,071,925 doses.

The tally of vaccine doses distributed and the number of people who received the first dose are for both Moderna and Pfizer/BioNTech, vaccines as of 9:00 amET on Saturday. (Reuters)

. The Centre has set up the Co-WIN platform website and app, registration upon which is mandatory in order to get a vaccine. Self-registration can be done on the platform, but prioritisation will be done on the basis of age and comorbidities.

Free vaccines would be provided in the first phase of the inoculation drive to the most prioritised beneficiaries, including one crore healthcare and two crore frontline workers, the Ministry of Health and Family Welfare said based on suggestions by the panel formed in August 2020.

Read more about the vaccination procedurehere

Coronavirus vaccine news highlights: We don't know for how long vaccine is going to be effective, says ICMR

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