Serum Institute
Serum Institute seeks DCGI's approval for Covishield as booster dose
Serum Institute of India has sought from India's drug regulator approval for Covishield as a booster dose citing adequate stock of the vaccine in the country and a demand for a booster shot due to the emergence of new coronavirus variants, reported The Economic Times quoting official sources.
In an application to the Drugs Controller General of India (DCGI), Prakash Kumar Singh, the Director, Government and Regulatory Affairs at Serum Institute of India (SII) cited that the UK's Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine, they said.
Singh is learnt to have said in the application that as the world continues to face the pandemic situation, many countries have started administering booster dose of COVID-19 vaccines.
"People of our country as well as citizens of other countries who have already been fully vaccinated with two doses of Covishield are also continuously requesting our firm for booster dose," an official source quoted Singh as having said in the application on Tuesday.
Also read: Govt decides to administer Covid booster dose to above-60 citizens
"You are aware that now there is no shortage of Covishield in our country and the demand for a booster dose is increasing day by day from the people who have already taken two doses in view of the ongoing COVID-19 pandemic and emergence of new strains."
It is the need of the hour and a matter of right to health of every individual that they should not be deprived of third dose/booster dose to protect themselves in this pandemic situation, Singh stated.
The Union government has informed Parliament that the National Technical Advisory Group on Immunization and National Expert Group on Vaccine Administration for COVID-19 are deliberating and considering scientific evidence for the need and justification for a booster dose.
Also read: Nasal vaccine booster dose may be used with Covaxin
Recently, Kerala, Rajasthan, Karnataka and Chhattisgarh have urged the Centre to decide on allowing booster doses of COVID-19 vaccine diseased amid concerns raised by 'Omicron', the new variant of SARS-CoV-2.
The Delhi High Court on November 25 directed the Centre to clarify its stand on administering booster doses to those who are fully vaccinated against coronavirus, saying it does not want a second-wave-like situation on account of being conservative.
2 years ago
Serum gets govt nod to produce Sputnik vaccine in India
The Indian government on Friday gave permission to Serum Institute to produce Russian Covid-19 jab Sputnik V in the country, a development that could also help end vaccine shortage in neighbouring Bangladesh.
The permission from India's drugs controller came two days after the country's leading vaccine maker sought its nod to manufacture the Russian Covid jab here.
"We have got preliminary approval for Sputnik V. But actual manufacturing will take several months. In the meantime, our focus remains Covishield," a spokesperson for Serum Institute told the local media.
Also read: Sputnik V production starts in India; 100 million doses to be produced annually
Serum's Covishield is being widely used in both India and Bangladesh's mega inoculation drives. Bangladesh has inked a deal with Serum to buy 30 million doses of Covishield, but a recent surge in Covid cases in India has now made the delivery of the remaining doses uncertain.
"However, if Serum manages to plug the gap in vaccine shortage in India, it will also be able to resume supply of the Covid jabs to Bangladesh. In that case, there will be no impediment from any official channel," government sources told UNB.
On Thursday, Serum said that it sought permission from India's drugs controller to produce Sputnik V in this country as well as indemnity against legal proceedings linked to the use of its vaccines here.
Also read: Sputnik V's Limited Rollout Begins In Hyderabad, Visakhapatnam Tomorrow
"SII put up an application to the Drugs Controller General of India on Wednesday, seeking permission to manufacture Sputnik V in India," a company official had said.
Another company official had told the media that all vaccine companies in India should get indemnity protection against liabilities "if foreign companies are granted the same".
Serum's demand came in wake of media reports that Prime Minister Narendra Modi's government could grant legal protection to foreign Covid vaccine makers Pfizer and Moderna.
Also read: Russian Vaccine Sputnik V: Things we should know to fight COVID-19
In a recent interview with a British daily, Serum's chief executive officer Adar Poonawalla had said that the company would increase the vaccine production capacity from the existing 2.5 billion to 3 billion doses a year within six months.
India is currently witnessing a ferocious second wave of Covid-19. At the same time, an acute shortage of Covid vaccines has seriously hampered the country's mass inoculation drive.
Prime Minister Modi rolled out the world's largest Covid vaccination drive in India on January 16. Covishield and local company Bharat Biotech's Covaxin are currently being given to citizens.
3 years ago
Covid-19: Bangladesh sees 41 deaths in 24 hours, lowest in 39 days
Amid the declining trend in Covid-19 infections and fatalities after an alarming surge in April, Bangladesh registered 41 coronavirus-related deaths in 24 hours until Thursday, pushing up the total fatalities to 11,796.
This is the lowest number of Covid deaths in the country after March 28 this year. Bangladesh saw 35 deaths on March 28.
However, 1,822 new cases were detected during the period after the test of 21,585 samples.
The mortality rate remained static at 1.53 percent, said the Directorate General of Health Services in a handout.
The number of Covid deaths came down to 50 after over a month on Wednesday as the country saw 50 deaths on April 1 and it had kept rising since then.
Manwhile, the daily infection rate fell to 8.44 percent from Wednesday’s 8.59 percent, according to the data provided by DGHS.
The latest figure pushed up the caseload to 7,69,160.
The body count soared to over 100 during April 16-19 and on April 25 but the daily fatalities have been falling gradually since then.
Also read: Covid-19 in Bangladesh: Around 21 pc of total deaths reported in April alone
Until now, the country has tested 55,82,263 samples.
In the last 24 hours, 3,698 patients recovered from Covid-19, putting the recovery rate at 91.29 %.
Bangladesh reported its first cases on March 8 last year, before confirming the first death 10 days later.
Vaccination Drive
Bangladesh kicked off its vaccination drive on February 7 with Oxford-AstraZeneca doses it purchased from the Serum Institute of India Pvt Ltd.
Bangladesh signed an agreement with Serum for 30 million doses. But a record number of cases in India has made the delivery of the doses uncertain.
The administering of the first dose and new registration for Covid-19 jab has remained suspended since April 26.
However, DGHS DG Prof ABM Khurshid Alam assured that Bangladesh will get 2.1 million doses of vaccines by early May.
Also read: Deal with Russia soon over Covid vaccine: Health Minister
In the last 24 hours, 43 people have received the first dose and 102,915 have received the second dose of Covid vaccine, a figure which is exactly the same of yesterday, according to the DGHS handout.
So far, a total of 72,48,829 people received vaccines where 33,13,424 people managed to complete their second dose.
Vaccine stock dwindling
The DGHS on Wednesday said the stock of the Covid-19 vaccine is running out in Bangladesh as there are only 14 lakh jabs in government hands with no sign in sight to get a fresh consignment of it from India.
Speaking at a virtual press briefing, DGHS spokesperson Dr Robed Amin said, “We had around one crore and two lakh vaccines in our hands…around 88 lakh jabs have already been administered as the first and second doses. Now we’ve some 14 lakh doses in stock.”
He said there will be a vaccine crisis if a fresh consignment does not arrive in the country before the existing stock is exhausted.
Drive intensified to get vaccines from US
Foreign Minister Dr AK Abdul Momen on Wednesday said the government has intensified its efforts to have vaccine jabs from the United States (US) as it will share up to 60 million doses of its Oxford-AstraZeneca Covid-19 vaccine with other countries.
Also read: Bangladesh seeks immediate delivery of 4 mn vaccine doses from US: FM
Vaccine production
The Cabinet Committee on Economic Affairs on April 28 approved in principle a proposal for producing Russian and Chinese Covid-19 vaccines in Bangladesh.
The government on April 29 approved the emergency use of Sinopharm, a Chinese Covid-19 vaccine, a day after approving the emergency use of Sputnik V vaccine of Russia.
“We’ll get 5 lakh doses of the Chinese vaccine as gift within 7-10 days. Then we’ll start distribution. Then the government will start buying those on G2G basis,” Mahbubur Rahman, Director General of DGDA told reporters.
On April 28, Dr Shahida Aktar, additional secretary of the Cabinet Division noted that the government will purchase vaccine technology from Russian and China through direct procurement method (DPM).
Lockdown extended until May 16
The government has issued a notification extending the ongoing lockdown until May 16 with six fresh directives alongside the existing ones to contain the spread of Covid-19.
According to the notification issued by the Cabinet Division, the officials of all government, semi-government autonomous and private organisations, banks and financial institutions have been asked to remain at their respective workstations during the upcoming Eid-ul-Fitr holidays.
Also read: Lockdown to continue until May 16, intra-district public transport services from May 6
Shops and shopping malls will remain open from 10 am to 8 pm maintaining health guidelines. If any kind of deviation and violation are seen, the shopping malls and shops will be closed instantly, says the notification.
Inter-district transport services will remain closed while only intra-district transport services will operate ensuring health guidelines from Thursday.
However, launch and train services will remain off.
3 years ago
Serum to return money if it fails to provide vaccine: Finance Minister
Serum Institute of India will return the money paid by Bangladesh for purchasing the Oxford–AstraZeneca vaccine if it fails to supply vaccine, said Finance Minister AHM Mustafa Kamal.
“We don’t know whether the vaccine will come or not. If we’re informed that the vaccine won’t come, then we’ll take the final decision,” he said while briefing reporters after a meeting of the Cabinet Committee on Public Purchase.
Mustafa Kamal, however, said negotiations with Serum are going on and nothing is final yet.
The minister said the agreement was signed with Serum for vaccine maintaining all the standards of an international contract usually has.
“This is not a verbal deal and there’re contractual obligations from the birth sides — Bangladesh and India,” he said adding that their obligation is to provide the vaccine to us.
Also read: India's Serum to produce Covid jabs overseas: Report
Mustafa Kamal went on saying, “We’ve been trying to get the (Oxford) vaccine. We’re also trying to get vaccines from other sources as vaccines are very important to save the lives of people.”
Vaccine stock running out
The Directorate General of Health Services (DGHS) has said the stock of the Covid-19 vaccine in Bangladesh is running out as there are only 14 lakh jabs in government hands with no sign in sight to get a fresh consignment of it from India.
Speaking at a virtual press briefing on Wednesday, DGHS spokesperson Dr Robed Amin said, “We had around one crore and two lakh vaccines in our hands…around 88 lakh jabs have already been administered as the first and second doses. Now we’ve some 14 lakh doses in stock.”
Also read: Bangladesh OKs Import of 30m Oxford-AstraZeneca doses from Serum
He said there will be a vaccine crisis if a fresh consignment does not arrive in the country before the existing stock is exhausted.
Robed said 58,19,719 people have so far received the first dose of the vaccine while 30,23,169 got the second one.
As per official statistics, the country lacks over 14 lakh second doses of the vaccine to administer those who received the first jab.
Also read: India's Serum Institute to launch another Covid vaccine by June
Amid the vaccine crisis, the government suspended administering the first dose of the coronavirus vaccine on April 26.
The DGHS spokesman, however, hoped that the county may get vaccine doses from Chain before Eid-ul-Fitr.
3 years ago
India's Serum to produce Covid jabs overseas: Report
Unable to cope with the growing demand for its Covid-19 jabs in India and abroad, the Serum Institute is reportedly planning to soon start the production of the Oxford-AstraZeneca vaccine in other countries as well.
Serum's Covishield is being widely used in both India and Bangladesh's mega inoculation drives. Bangladesh has inked a deal with Serum to buy 30 million doses of Covishield, but a recent surge in Covid cases in India has made the delivery of the remaining doses uncertain.
Read Will soon come out of uncertainty over vaccine availability: Minister
Serum's chief executive officer Adar Poonawalla revealed his plans to set up vaccine
production units outside India in an interview with The Times newspaper. "There's going to be an announcement in the next few days," he told the British daily.
Poonawalla hoped to increase the Serum Institute's production capacity from the existing 2.5 billion to 3 billion doses a year within six months, the newspaper reported.
Read Bangladesh approves emergency use of Russian Sputnik V vaccine
India is currently witnessing a ferocious second wave of Covid-19. On Saturday, the country registered a record four lakh cases in a span of 24 hours, for the first time after reporting over three lakh daily infections for nine days in a row.
Indian Prime Minister Narendra Modi rolled out the world's largest Covid vaccination drive on January 16. Covishield and local company Bharat Biotech's Covaxin are currently being given to citizens. However, several states in India have run out of Covid vaccines.
Read PVA bats for suspension of intellectual property rights on Covid jabs
3 years ago
Will soon come out of uncertainty over vaccine availability: Minister
Health Minister Zahid Maleque on Tuesday said the uncertainty over receiving coronavirus vaccine jabs from the Serum Institute of India is likely to be over soon.
“We placed an order for three crore doses of vaccine (from Serum Institute) and paid money. But it’s a matter of regret that we’re not getting the vaccine in due time, disrupting our vaccination activities. The local agent, Beximco, and we’re trying our best to have it,” he said.
The minister said, “Our government is also trying to bring the vaccine jabs and the PMO and the Foreign Ministry have been working on it. Our Prime Minister Sheikh Hasina has repeatedly requested the Indian Prime Minister to ensure the vaccine supply. So, we hope we may get the vaccine quickly, but we couldn’t know the exact time. We’ll be able to know about it within a few days.”
Also read: Bangladesh to suspend administering Covid vaccine 1st dose from Monday
He made the remarks while talking to reporters on the premises of Bangladesh College of Physicians and Surgeons (BCPS).
3 years ago
Bangladesh begins second phase of Covid-19 vaccination drive
Bangladesh Thursday began its second phase of inoculating people against the coronavirus disease amid uncertainty around vaccine availablity.
State Minister for Shipping Khalid Mahmud Chowdhury got his second dose of the Covid-19 vaccine at Bangabandhu Sheikh Mujib Medical University. He took the first shot of the vaccine at the same medical facility on February 8.
Also Read: Covid vaccination in Bangladesh to start in first week of Feb
“We should not depend only on vaccines to be free of coronavirus. Everyone should be more aware and abide by the health directives issued by the government,” the Minister said after receiving the jab.
State Minister for Information and Communication Technology Junaid Ahmed Palak also got his second dose of the Covid-19 vaccine at BSMMU, while Textile and Jute Minister Golam Dastagir Gazi received the jab at the National Heart Institute, Dhaka.
The government is supposed to get 50 lakh doses of the Oxford-AstraZeneca vaccine every month as per a deal between India's Serum Institute and Bangladeshi pharma company Beximco.
The country has so far received two shipments of 70 lakh doses of the Covid-19 vaccine. Apart from this, Bangladesh received two consignments of 32 lakh doses of the vaccine as gifts from India.
3 years ago
Second dose of Covid vaccine from Thursday: PM
Prime Minister Sheikh Hasina on Monday reaffirmed that the second dose of Covid-19 vaccine will be rolled out on Thursday next (April 8) as per the schedule.
She came up with the reassurance while presiding over the weekly Cabinet meeting virtually from her official residence Ganobhaban.
“The Prime Minister has made it clear that the roll-out of the second dose of coronavirus vaccine will begin on April 8 as usual as per the schedule,” said Cabinet Secretary Khandker Anwarul Islam while briefing reporters after the meeting held at the Bangladesh Secretariat.
The roll-out of the first jab of the covid-19 vaccine will start on April 6, he said.
Also Read: 20-30 lakh more doses of Covid-19 vaccine to arrive Feb 22
The Cabinet Secretary said there will be no problem with the stock of the second dose of the vaccines as Bangladesh will get the supply of the vaccines from India within the scheduled time.
The government will review on Thursday next whether the ongoing 7-day Covid-19 lockdown should be extended or not, he said.
Festival allowance for FFs
The Cabinet cleared a proposal for providing two festival allowances (each Tk 10,000) to the gallantry award holding freedom fighters, Tk 2,000 as the Bengali New Year allowance to gallantry award holding freedom fighters, war-wounded freedom fighters and martyred freedom fighters’ families and Tk 5,000 as the Victory Day allowance to the living freedom fighters, said the Cabinet Secretary.
Now the gallantry award holding freedom fighters are not getting the two festival allowances, the Bengali New Year allowance and the Victory Day allowance, while war-wounded freedom fighters are not getting the Bengali New Year allowance and the Victory Day allowance and the martyred freedom fighter’s families are not getting the Bengali New Year allowance, he said.
3 years ago
Africa CDC says India vaccine woes could be 'catastrophic'
Africa is unlikely to meet its targets for vaccinating the continent against COVID-19 if supply delays from a key Indian manufacturer continue, the director of the Africa Centers for Disease Control and Prevention warned Thursday.
Dr. John Nkengasong told a press briefing that officials hope the problems at the Serum Institute of India will only be temporary otherwise “it would definitely impact our ability to continuously vaccinate people.”
"I really want to deliberately hope that it is a delay — not a ban — because that would be catastrophic,” he said.
Also read: German cities suspend AstraZeneca vaccine use for under-60s
More than half of the 29.1 million vaccine doses received by African nations so far have come through the global COVAX initiative, which aims to ensure that low- and middle-income countries have fair access to vaccines. COVAX has largely relied on distributing the AstraZeneca vaccine, because it is cheaper and only requires ordinary refrigeration.
But the Serum Institute of India recently announced that as many as 90 million doses of the AstraZeneca vaccine destined for COVAX worldwide will be delayed through the end of April as India’s government grapples with a spike in infections among the country's 1.4 billion people.
Nkengasong said it is not yet known what impact the uncertainty might have for scheduling second doses of the AstraZeneca vaccine in African countries.
“We are tracking that very, very closely,” he said Thursday. “I’m sure countries are still trying to finish vaccinating their first round of the vaccines that were received.”
Also read: Johnson & Johnson COVID-19 vaccine batch fails quality check
Nkengasong remained optimistic, though, that a deal announced on Monday for African countries to acquire the single-dose Johnson & Johnson vaccine remains “an historic moment and a game-changer.”
The agreement with the African Union's African Vaccine Acquisition Trust calls for 220 million doses to be delivered by the third quarter of this year, with an option to acquire an additional 180 million doses through 2022.
If those 400 million people receive the Johnson & Johnson vaccine, it would represent more than half the continent's goal of 750 million, Nkengasong said.
Africa has confirmed more than 4.2 million cases and 112,000 deaths, but since most countries on the continent lack the means to track mortality data, it is not clear how many excess deaths have occurred since the pandemic began.
Also read: African expert warns of 'vaccine war' over access to jabs
3 years ago
No uncertainty over receiving vaccine doses: Finance Minister
Finance Minister AHM Mustafa Kamal has ruled out any uncertainty over receiving vaccine doses from the Serum Institute of India Pvt Ltd.
“We’ve already paid for the vaccine. So... we’ll get it,” he told reporters while briefing virtually on the Cabinet Committee on Public Purchase on Wednesday.
Also read: Vaccine drive to continue with AstraZeneca shot: Health Secretary
He informed that the second dose of vaccine will be administered in time.
He also said that the health minister had also attended the purchase body meeting and did not express any apprehension over uncertainty about receiving the vaccine doses.
Also read: Virus variants, vaccine inequity responsible for rising Covid caseload: WHO
Mustafa Kamal also turned down the idea of going for lockdown to contain coronavirus transmission. He said there will be no need for any such measures as the vaccination programme has been continuing.
“Once vaccination is completed, the situation will improve,” he said. “The countries, which are running the vaccination programme, are witnessing a fall in infection.”
Also read: Modi to bring 12 lakh more vaccine doses as gift for Bangladesh
Responding to a question on World Bank’s economic growth projection at 3.6 percent, the Finance Minister said the donor agency makes such projection on quarterly basis and the government does it annually.
3 years ago