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vaccine

The DCGI has approved a phase II/III trial of Bharat Biotech’s nasal Covid vaccination

by Medically Speaking August 14, 2021

written by Medically Speaking

The Union ministry of science announced on Friday that Bharat Biotech has received authorisation from India’s pharma regulator to undertake mid-to late-stage trials of their nasal Covid-19 vaccine candidate.

“This is the first Covid-19 vaccine to go through human clinical trials in India,” says the company “According to the ministry. ”

“BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.BBIL has in-licensed technology from Washington University in St Louis, USA,” it added.

Early stage trials of the vaccine candidate, BBV154, has been completed in subjects aged 18 to 60 years. The company has said that the doses of the vaccine administered to healthy volunteers were found to be well tolerated.

“Bharat Biotech’s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials,” said Renu Swarup, chairperson of the Biotechnology Industry Research Assistance Council.

The company’s Covaxin Covid-19 vaccine was approved for emergency use in the country in January this year. It is being administered through an injection in the country’s inoculation drive.

Suchitra Ella, Joint Managing Director, Bharat Biotech, on Thursday, said the Hyderabad-based company has supplied 75 million doses of Covaxin so far and more will be supplied this month.

The Bharat Biotech official said that Covaxin has 65% efficacy against the B.1.617.2 delta variant of Covid-19. “Our second site is at Ankleshwar-based manufacturing plant. Sample batches are ready, it’ll go to CDL Kasauli this month for quality testing,” Ella added.

Last month, the vaccine maker said it has committed to supply over 500 million doses of Covaxin to the government under the nationwide immunisation programme.

Speaking at a virtual meet organised by the Confederation of Indian Industry, Ella said the firm facilities in four cities – Hyderabad, Bengaluru, Pune and Ankleshwar – are currently producing Covaxin.

Covaxin demonstrated 77.8% effectiveness against symptomatic coronavirus and 65.2% protection against the B.1.617.2 Delta variant, Bharat Biotech said recently, while announcing the final analysis of the jab.

August 14, 2021 0 comment

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J&J Doses Expected to Arrive in India in November-December, Zydus Cadila Next

by Medically Speaking August 14, 2021

written by Medically Speaking

After the Centre gave the foreign Covid-19 vaccine producer Emergency Use Authorization (EUA) last week, India is set to receive the first doses of Johnson & Johnson’s single-shot vaccine in November or December this year, according to a top government source.

After Covishield, Covaxin, and Sputnik, the government expects Zydus Cadila’s DNA vaccine, which may receive FDA approval soon, to be the next coronavirus vaccine to come. Zydus Cadila is expected to deliver two crore dosages per month, according to the source.

The vaccine from Biological E is also expected with an initial lot of seven crore doses in one go as the firm is doing at-risk production after the Centre extended it a Rs 1,500 crore advance. “The firm will soon apply for comparative studies and their data is good,” the source further said. Gennova’s vaccine is also expected in October.

The government source said that the priority right now was expanding the capacity of Bharat Biotech with its three plants becoming functional now. “In August, we will be getting three crore doses of Covaxin, which will go up to four crore in September and 6-7 crore from October,” the government source said, adding that Hyderabad-based firm Bharat Biotech had suffered as first batch of the manufacturer had failed.

Pune-based Serum Institute of India (SII) will supply nearly 15 crore doses of Covishield every month and is keen to start export of the vaccine. The government has told the SII that vaccinating Indians is a priority for now.

Meanwhile, the government is banking on only one crore doses of Russia’s Sputnik V vaccine in all as the local manufacturers are facing a trouble in producing the second dose of the vaccine, whose component is different from the first.

Regarding the approval of Covaxin by the World Health Organisation, the government source said a last dossier will go to the WHO in a couple of days and the WHO could soon call an expert committee meeting to give clearance.

August 14, 2021 0 comment

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KMC Covishield-only locations are now closed due to a lack of supplies

by Medically Speaking August 8, 2021

written by Medically Speaking

Just as the Kolkata Municipal Corporation (KMC) was able to restock Covaxin, it ran out of Covishield vaccines today, forcing 102 urban primary health centres (UPHC) and 50 mega centres to close temporarily.

Several persons who were waiting outside the clinics for their Covishield vaccine doses today returned dismayed when they saw the clinics had closed and notifications of non-availability had been posted. The KMC has announced that until inventories are restocked, its 102 UPHCs and 50 mega centres that only administer Covishield will remain closed.

The civic body, however, has not specified when it can again start the process. A KMC official said that presently the civic body is uncertain as to when new stocks would arrive and hopes it does soon. Many who arrived at the Covishield mega centre at Elite cinema were found annoyed after coming to know its shut. The civic body realised it ran out of Covishield stock late last evening.

People who came to these centres were surprised to find it shut. The civic body but has informed that its 40 UPHCs administering Covaxin would continue with inoculations. KMC’s vaccination drive took a major blow today since it is Covishield doses that are being administered in large numbers than Covaxin. The KMC has only 39 Covaxin centres and the rest administer Covishield.

In July-end the KMC had run out of Covaxin doses which had jolted the inoculation programme as many who were due to get their second doses, ran from pillar to post looking for it. Currently, the civic body requires about 35,000 Covishield doses each day for its UPHCs and mega centres to keep running.

A KMC health department official said if supplies keep running out so frequently, it will be difficult to cope with a probable third wave. The centre needs to supply adequate vaccines to ensure the pace of vaccination must remain unaffected. The chief minister Mamata Banerjee wrote to Prime Minister Narendra Modi yesterday for the supply of more vaccines.

She said, “West Bengal needs around 14 crore doses of a vaccine to cover the entire population but it has received only 2.68 crore doses so far from the central government”. According to Miss Banerjee, the state has administered 3.08 crore doses till now, of which 2.20 crore people have been administered with the first dose and 88.93 lakh with the second dose.

August 8, 2021 0 comment

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People with both doses of Covishield have higher immunity against Delta variant ICMR study suggests

by Medically Speaking Team August 4, 2021

written by Medically Speaking Team

New Delhi: A study published by ICMR and National Institute of Virology, Pune shows that people with both doses of Covishield vaccine have higher immunity against the Delta variant of the coronavirus.

It also said that COVID-19 recovered individuals who were administered Covishield had higher neutralizing responses against the Delta variant.

“The study demonstrated that the breakthrough cases and the COVID-19 recovered individuals with one or two doses of Covishield vaccine had relatively higher neutralizing responses against the Delta variant in comparison to the participants who were administered either one or two doses of Covishield,” it said.

A comparative assessment of Covishield vaccinated individuals were conducted and sera under this study were grouped into five categories: People who took one dose, those who were administered two doses, COVID-19 recovered people who got one dose, COVID-19 recovered individuals who received two doses and breakthrough COVID-19 cases.

An increase in NAb titers was observed for both B.1 and Delta variants in the sera of the participants who had completed two vaccine doses relative to one dose.

Neutralizing antibody titers against B.1 and Delta variants were highest among breakthrough participants which may be due to spike-specific T-cell responses.

A titer is a test that measures the presence and amount of antibodies in the blood.

The study found that significantly lower NAb titers were observed for the Delta relative to B.1 variant. However, NAbs in breakthrough participants and the COVID-19 recovered individuals with one or two-dose vaccination had relatively higher protection against Delta in comparison to the vaccines with one or two-dose vaccination.

Long-term follow-up of participants could help to understand the impact of natural infection and vaccination on long-term protection from SARS-CoV-2 offered by Covishield.

It is important to track the breakthrough infections for immune escape mutants, the report said.

August 4, 2021 0 comment

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India’s COVID-19 Vaccination Coverage surpasses landmark milestone of 42 Cr

by Medically Speaking July 23, 2021

written by Medically Speaking

According to a recent provisional report by the government, the cumulative across the country has crossed the 42 crore landmark on Thursday, Day 188th of the Covid-19 vaccine drive. More than 48.86 lakh (48,86,103) Vaccine Doses have been administered as per the 7 pm provisional report.

Cumulatively, 13,29,60,281 persons in the age group 18-44 years across 37 States/UTs have received their first dose and total 55,40,162 have received their second dose since the start of Phase-3 of the vaccination drive. Three States namely Madhya Pradesh, Maharashtra and Uttar Pradesh have administered more than 1 Crore Cumulative Doses of COVID-19 Vaccine in the age group 18-44 years. Also, Andhra Pradesh, Assam, Chhattisgarh, Delhi, Haryana, Jharkhand, Kerala, Telangana, Himachal Pradesh, Odisha, Punjab, Uttarakhand and West Bengal have vaccinated more than 10 lakh beneficiaries of the age group 18-44 years for the first dose of COVID vaccine.

July 23, 2021 0 comment

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CDC advisers will meet Thursday to discuss need for coronavirus boosters and J&J vaccine safety

by Medically Speaking July 22, 2021

written by Medically Speaking

Vaccine advisers from the US Centers for Disease Control and Prevention will meet on Thursday to make recommendations on how to address new safety concerns about Johnson & Johnson’s Covid-19 vaccine, as well as to review preliminary data on whether Covid-19 vaccine boosters will be required in the future, particularly for people with compromised immune systems.

From 11 a.m. to 4:30 p.m. ET, the Advisory Committee on Immunization Practices (ACIP) will convene. The panel is not expected to vote on any of the topics on the agenda.

ACIP is a panel composed of outside medical experts in the fields of vaccinology, immunology, pediatrics, internal medicine, nursing, virology, public health, infectious diseases and other subspecialties. CDC typically accepts its recommendations once votes have been cast.

ACIP has provided crucial guidance throughout the pandemic including advice on emergency use authorization for the three Covid-19 vaccines currently available in the US, authorization of Pfizer’s vaccine for 12-15 year-olds and, in April, to end the pause of the J&J vaccine due to a rare blood clotting disorder that has occurred in a small number of vaccine recipients.On Thursday, ACIP will take up several new issues regarding safety and durability of Covid-19 vaccines.

To start, ACIP will review recent data on cases of Guillain-Barré Syndrome (GBS) among people who have been vaccinated against Covid-19 with the J&J coronavirus vaccine.

Federal health officials say there have been some 100 preliminary reports of cases of GBS — a rare neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes temporary paralysis — among the nearly 13 million people who have received the vaccine.

July 22, 2021 0 comment

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Private hospitals are scrambling to place vaccination orders with a 24-hour deadline

by Medically Speaking July 16, 2021

written by Medically Speaking

Private hospitals raced on Thursday to submit vaccination orders since the Centre only allowed them a 24-hour window (Wednesday to Thursday) to place the order and pay for it. According to the Private Institutions and Nursing Homes Association, private hospitals may only make orders for three lakh pills till Wednesday evening (PHANA)

The constant flip-flap in vaccine procurement procedures has led private hospitals to lose interest. PHANA Precident Dr.Prasanna HM said hospitals have been made to place incidens thrice so far, first with the state government, then with the Karnataka Private Medical Established portal(10 lakh doses incidents raised), and then Co-WIN portal which did not work until Monday.
“On Wednesday there were a communication from the immunization deputy director that by Thursday 2:00pm all vaccine incidents have to be raised and paid for. How many can do that within 25 hours? People have lost interest. We have requested for an extension,” he said. National Health Mission Director Dr. Arundhati Chandrasekhar did not respond to DH’s queries.

Meanwhile, Bharat Biotech has apparently sent feelers to city hospitals to buy vaccines directly. Three hospitals have already bought vaccine doses according to Prasanna. “I do not want to name these three hospitals. But the purchase happened after june21, and the payment happened within a day,” he said.

July 16, 2021 0 comment

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“We’re in the early stages of the third wave,” the WHO warns, citing the Delta Surge as an example

by Medically Speaking July 15, 2021

written by Medically Speaking

Geneva: In the midst of the Delta surge, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus issued a warning to the world about the ‘early phases’ of COVID-19’s third wave.

He remarked, “Unfortunately, we are already in the early phases of a third wave.”

On Wednesday, the head of WHO said that Delta variant’s spread, along with increased social mobility and the inconsistent use of proven public health measures, is driving an increase in both case numbers and deaths.

Recalling the sustained decline in COVID-19 cases and deaths that was being driven, in recent months, by increasing vaccination rates in Europe and North America, he sounded alarms over the fresh reversal of that positive trend, reported UN News.

Meanwhile, said Tedros, the virus is continuing to evolve, resulting in more transmissible variants.

“The Delta variety is now in over 111 countries, and if it isn’t already, we expect it to become the main COVID-19 strain circulating worldwide soon,” he said.

Last week marked the fourth consecutive week of rising cases of COVID-19 globally, with increases recorded in all but one of WHO’s six regions. Deaths are also rising again, after 10 weeks of steady decline.

Tedros also drew the Emergency Committee on COVID-19’s attention to the ongoing “shocking disparity” in the global distribution of vaccines, as well as unequal access to life-saving tools, reported UN News.

He reiterated his concern that inequity has created a two-track pandemic – namely, one track for countries with the greatest access to vaccines, who are lifting restrictions and reopening their societies, and a second track for those without vaccines access who are left “at the mercy of the virus.”

July 15, 2021 0 comment

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Women given 3 shots of jab in a minute

by Medically Speaking Team June 29, 2021

written by Medically Speaking Team

On Friday in Anandnagar, a 28-year-old woman from Thane claimed she was administered three doses of Covid-19 vaccine within minutes at a vaccination centre. The case of gross negligence came to light after the alarmed woman narrated the incident to her husband, an employee of the Thane Municipal Corporation (TMC). The husband then raised the issue with the local corporator.

Following this, the civic body provided support and monitored his wife’s health. The woman, who preferred to remain anonymous, said she was not interested in filing a complaint as her husband worked for the local civic body.

The woman’s husband said his spouse was not familiar with the vaccination process as she was getting a Covid-19 vaccine for the first time. “She had a fever on the day she got back-to-back shots, but it subsided the next morning. She is doing fine now,” the husband said.

TMC medical health officer Dr Khushboo Tawre told India Today, “A team of doctors went to the victim’s house and found her in good health. We have formed a committee to investigate the matter.”

In light of the incident, a delegation of BJP leaders cornered Thane Municipal Commissioner Bipin Sharma and slammed him for negligence by the vaccination centre staff.

Speaking to India Today, BJP MLA Niranjan Davkhare said, “How did such a grave oversight happen? How did the staff members not notice that the same woman was vaccinated thrice? We have demanded strict action against those responsible.”

The civic body officials are now probing the incident and strict action will be taken against those found guilty, assured Thane Mayor Naresh Mhaske.

June 29, 2021 0 comment

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Cipla receives DCGI nod for import of Moderna’s Covid-19 vaccine for restricted emergency use in India

by Medically Speaking Team June 29, 2021

written by Medically Speaking Team

India’s drug regulator DCGI has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna’s COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.

Moderna’s vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik.

“Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna’s COVID-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules, 2019 under Drugs and Cosmetics Act, 1940,” a source told PTI.

The company sought Drugs Controller General of India (DCGI) nod for importing Moderna’s coronavirus vaccines, sources informed ANI. According to the sources, Cipla filed an application recently seeking permission for import of Moderna Covid-19 vaccine referring to DCGI notices dated April 15 and June 1 stating that if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorization without trial and assessment of safety data first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.

Moderna’s method to protect against Covid-19 relies on messenger RNA (mRNA) to program cells to generate immunity to the coronavirus. The vaccine has shown more than 90 % efficacy in clinical trials in protecting against Covid-19.

June 29, 2021 0 comment

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