COVID-19 vaccine
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.
Bangavax finally gets approval for human trial
Bangladesh Medical Research Council (BMRC) has approved in principle Globe Biotech Limited’s Covid-19 vaccine Bangavax for human trial.
“BMRC has given the approval in principle for administering Covid-19 vaccine of Bangavax and we’ll submit an application to the Bangladesh Directorate General of Drug Administration (DGDA), seeking its permission for the clinical trial. The administration of its jabs will start once the final approval is given,” said Dr Mohamamd Mohiuddin, senior manager of BMRC’s Quality and Regulatory Department.
BMRC Director Dr Ruhul Amin signed the letter of approval issued on Tuesday.
Globe Biotech Limited has claimed that Bangavax is 100% effective for fighting 11 variants of Covid-19, including the Delta variant.
Read: Bangavax trial turning into ‘monkey business’ for Globe?
On January 17, Globe Biotech, the only Bangladeshi company trying to develop a Covid-19 vaccine, submitted an application to the BMRC for approval to conduct Bangavax's clinical trials.
On June 16, the BMRC decided to approve Globe Biotech's Covid-19 vaccine, Bangavax, for human trials.
Globe Biotech received a licence to produce their potential vaccine for trial on December 28 last year.
The BMRC, which oversees all such trials, got back to them in June with certain conditions that had to be met before the clinical trials could go ahead.
Read: GM Quader seeks govt support for local vaccine Bangavax
The key condition was that Globe Biotech would have to run trials on monkeys or chimpanzees first.
One of the bottlenecks the company identified at the time was that the country did not have a third-party clinical research organization (CRO) that could conduct such tests on animals.
UK rules recognising Covaxin for inbound travel come into effect from today
The changes announced by the United Kingdom, adding India's Covaxin to the list of approved Covid-19 vaccines for international travellers, will come into effect from November 22. This means that thousands of travellers from India, who have been inoculated with the Bharat Biotech-manufactured jab, will not have to self-isolate after arrival in Britain, reported Hindusthan Times.
The UK government has also added China’s Sinovac and Sinopharm in its list of approved vaccines, benefiting fully vaccinated people from the United Arab Emirates and Malaysia too. Around one billion doses of these three Covid-19 vaccines have been delivered worldwide.
Also read: 77.8% efficacy, robust antibody response: 5 points from Lancet's new study on Covaxin
The changes were announced earlier this month, after the World Health Organization (WHO) cleared their “emergency-use listing”.
The WHO issued an emergency-use listing for Covaxin on November 3.
The UK began recognising Covishield, the Indian version of the AstraZeneca vaccine, for inbound travel from October 4.
It also began accepting India’s vaccine certificates from October 11, ending a travel row that had resulted in UK nationals facing mandatory 10-day quarantine on arrival even if they were fully vaccinated.
Covishield and Covaxin are the two main vaccines being used for India's immunisation programme. The country has also approved Russia-made Sputnik and Johnson & Johnson's single-dose vaccine.
Last week, government officials said that as many as 110 countries have given recognition to Covaxin and Covishield, according to news agency ANI. Among these countries are New Zealand and Australia.
Also read: Covid vaccine: India-made Covaxin approved by WHO for emergency use
Covaxin and Covishield were the first two jabs to receive emergency use authorisation (EUA) from the Drugs Controller General of India (DCGI) for the nationwide inoculation drive, which commenced on January 16. The former has been developed by the Hyderabad-based Bharat Biotech International Limited, and is the first made-in-India anti-Covid shot. The latter is the Indian variant of Britain's AstraZeneca vaccine, and manufactured locally by the Pune-based Serum Institute of India (SII).
US donates 18 freezer trucks for vaccine delivery in Bangladesh
The United States has purchased 18 trucks to help Bangladesh establish a dedicated fleet of specialized cold-chain vehicles to deliver COVID-19 vaccines across the country.
US acting Deputy Chief of Mission (DCM) William Dowers and US Agency for International Development (USAID) Mission Director Kathryn Stevens handed over the brand new freezer trucks to Health and Family Welfare Minister Zahid Maleque as part of the ongoing US support to the COVID-19 vaccination campaign in Bangladesh.
Read: Bangladesh plans to import huge petroleum fuel amid global market volatility
USAID purchased four trucks on the local market with an additional 14 vehicles to arrive in the coming months, said the US Embassy in Dhaka.
The total US government COVID-19 assistance to Bangladesh exceeds $121 million.
USAID partnered with the International Federation of the Red Cross and Red Crescent (IFRC) and Bangladesh Red Crescent Society, the agencies that will oversee the procurement of these vehicles and support the Ministry of Health and Family Welfare to roll out COVID-19 vaccinations across the country.
“We hope to sustain the impressive momentum Bangladesh has made in turning the tide against the pandemic. Through our work, we are helping to get more people vaccinated so they can protect themselves and their loved ones, and return to more normal lives,” said acting DCM Dowers.
Covid: Students in Manikganj queue up for a shot in the arm
Senior students of Government Debendra College in Manikganj formed queues at a Covid jab centre in Sadar upazila on Saturday to get a shot in the arm.
Some 1,542 Class 12 students of the college are slated to get Covid jabs during the day as part of the government's ongoing drive to vaccinate school-goers of the 12-17 age group against Covid-19.
Read: Uber to provide 50,000 free rides for Covid vaccine seekers in Dhaka
Authorities of the local health department said that these students would get the first dose of a Covid vaccine at Health Training Center in Sadar upazila on Saturday.
The vaccination drive began around 9am in four booths -- male and female separate -- set up at the centre. Besides, 14,000 more Higher Secondary Certificate examinees will be vaccinated in phases in the district.
Dr Lutfur Rahman, the acting Civil Surgeon of the district, said that the Bangladesh government has set a target to vaccinate 50,000 students under the campaign.
In fact, the campaign to vaccinate the school students against Covid-19 began in Dhaka on November 1.
Health Minister Zahid Maleque and Education Minister Dipu Moni had jointly inaugurated the vaccination campaign at Motijheel Ideal School and College.
Read: France to donate 2mn doses of Covid-19 vaccine to Bangladesh: FM
According to health authorities, so far, 6.23 lakh people have received the first dose in the district, while 3.42 lakh people in the district got both the doses of a Covid jab.
Dhaka makes 5-point call; seeks time-bound action plan to deal with Covid
Foreign Minister Dr AK Abdul Momen has made a five-point recommendation, including the necessity of undertaking a time-bound action plan, supported by financing and capacity building, for addressing the unwarranted vaccine gap for many low- and middle-income countries.
He made the recommendations during a virtual Covid-19 Ministerial meeting held recently.
Dr Momen attended the meeting at the invitation of United States Secretary of State Antony J Bliken.
Read: France firmly with Bangladesh over Rohingya issue: FM Momen
The meeting was also attended by the foreign ministers of around 25 countries, said the Ministry of Foreign Affairs on Friday.
Dr Momen suggested convening a high-level panel by the WHO featuring select global leaders to devise a blueprint for preventing and managing future pandemic, ideally with gender and geographic balance.
In his third recommendation, the Foreign Minister called for the US and the WHO to take the lead in convening an expert working group on the question of strengthening national-level disease control agencies.
He also mentioned supporting the vaccine manufacturing capabilities in certain countries like Bangladesh in the Global South, in a meaningful manner through appropriate interventions concerning intellectual property rights and technology transfer.
In his fifth recommendation, Dr Momen called for factoring the linkage between climate change and biodiversity loss with pandemic outbreaks in the collective efforts to build back better, greener and stronger from the pandemic.
Read: US announces another 14mn Pfizer jabs for Bangladesh
In his statement during the meeting, the Foreign Minister highlighted the fact that Bangladesh has managed to keep the fatality rate lower than the global average.
He also informed that the infection rate in Bangladesh remains under 1 percent at present.
Contrary to some dire projections, Dr Momen said, Bangladesh managed to keep the infection and death rates absolutely minimal in the congested Rohingya camps Cox’s Bazar.
Dr Momen reiterated Bangladesh’s demand that the Covid-19 vaccines should be declared as ‘global public good’ to make them affordable to all countries.
He also urged that pharmaceutical companies, including those in Bangladesh, should be encouraged and assisted to produce Covid-19; and stated that Bangladesh stands ready to contribute to global vaccines production for sharing with others.
Recalling that Bangladesh has so far administered 78 million vaccine doses, with 46 million single doses and 32 million double doses, Minister Momen stated that the target is to vaccinate 80% of Bangladesh’s target population group by March 2022, and continued supply of vaccines is required for that.
The Foreign Minister underscored the fact that no country would remain completely safe until the mutating coronavirus is brought under control in all corners of the globe, and for this there is no other option but to ensure inclusive international cooperation, leaving no one behind.
He stressed the necessity to have strong partnership and collaboration among the foreign ministers to step up political support in such critical situations at present and also in the future.
Earlier, US Secretary of State Blinken urged the foreign ministers to work together to address the challenges posed by the pandemic, and announced the launch of a Covid Data Tracker.
Stating that vaccines will be made available in conflict-affected areas, he said a concerted work would be undertaken to meet the estimated shortfall of 550 million doses of vaccines required to bring the entire target population group under vaccination coverage.
Secretary Blinken presided over the sessions, with IMF Managing Director, US NIH Director and WHO Director General setting the scene.
In addition to the Bangladesh Foreign Minister, the Foreign Ministers of the EU, France, Germany, Spain, Italy, Norway, Romania, Canada, Mexico, Chile, Peru, India, Indonesia, the Maldives, ROK, South Africa, Senegal and Kenya were invited to speak.
The Senior Representatives of the African Union, Pacific Island Forum and League of Arab States, Organisation of American States also spoke at the event.
Poland hands over token vaccine doses under 3.2-mn AZ donation
The Polish government has provided 3.2 million AstraZeneca vaccine doses to Bangladesh expressing solidarity to the friendly country’s fight against Covid-19 pandemic.
Prof Adam Burakowski, the Ambassador of Poland to Bangladesh (resident in New Delhi), handed over the token vaccine doses to Bangladesh side at a ceremony held at state guesthouse Padma on Wednesday.
Read: Pfizer asks FDA to OK COVID-19 booster shots for all adults
Lokman Hussain Mia, Senior Secretary of Health Services Division under the Ministry of Health and Family Welfare of the Government of Bangladesh and Rear Admiral (retd) Md Khurshed Alam, Secretary, MAU and acting Foreign Secretary, received the gifts from the Ambassador at the Padma State Guest House a simple ceremony.
The Polish gesture covers a consignment containing 3272, 880 doses of the Covid-19 vaccine (Oxford AstraZeneca) as well as their transport to Dhaka through their own arrangement.
Due to the size, the consignment is being sent in three batches.
The first batch (1027,290 doses of vaccine) arrived on Wednesday and the second batch (920,790 doses of vaccine) will arrive on Thursday.
The third one (1324,800 doses of vaccine) will arrive on November 14.
Read: France to donate 2mn doses of Covid-19 vaccine to Bangladesh: FM
The Polish Ambassador said the Covid vaccines are a donation to the government of Bangladesh by the government of Poland as a gesture of friendship to Bangladesh.
He expressed the hope that both the countries would soon be able to overcome the pandemic through shared efforts.
The acting Foreign Secretary thanked the government of Poland for standing by Bangladesh and mentioned that the friendly gesture would further strengthen the existing bilateral relationship between the friendly countries.
He also appreciated the support of Poland in such a time when the government of Bangladesh planned to inoculate its population.
The handing over ceremony was followed by lunch hosted by the acting Foreign Secretary.
Serum Institute looks to supply 25 million doses to Covax till December
Pune-based Serum Institute of India (SII) is expected to supply 25 million doses to the Covax facility till December, as it looks to resume supplies to the WHO-led Covax facility this month. Earlier in March, the government had imposed a hold on all major exports affecting the Covax deliveries.
"The supplies will resume soon. SII is supposed to supply 25 million doses till December," reports The Economic Times.
Read: India raises finance concern as COP 26 enters second week
In an interview to ET in October, SII CEO Adar Poonawalla said small exports will start soon. "I think January onwards there will be large exports to Covax because by then India will have more than enough vaccines. Already, there is more stock than what we are vaccinating. So, we will be in a very good situation. Combine that with the fact that other Indian vaccine manufacturers are also scaling up," it said.
Read: Top India honours for ex-diplomat Syed Muazzem Ali & scholar Enamul Haque
The Covax facility was created last year to ensure Covid vaccines were made available around the world, with richer countries subsidising costs for poorer nations. The scheme hoped to distribute enough vaccines to protect at least 20% of the population in 92 low-or medium-income countries.
France to donate 2mn doses of Covid-19 vaccine to Bangladesh: FM
Foreign Minister Dr AK Abdul Momen on Wednesday said France declared 2 million doses Covid-19 for Bangladesh as donation.
The announcement came after Prime Minister Sheikh Hasina's meetings with French President Emmanuel Macron and French Prime Minister Jean Castex, Dr Momen said.
Bangladesh will get around 1.5 million doses of AstraZeneca vaccine from Saudi Arabia.
Also Read: Warm welcome to Hasina at French presidential palace
"Our Ambassador in Riyadh has informed me that 1499270 doses of AstraZeneca vaccine will come from the King Salman Relief Fund," he said in a message from Paris.
The vaccine doses will arrive in Dhaka over the next two to three days, Dr Momen said.
Meanwhile, he said, Poland will provide 3.3 million AstraZeneca vaccine doses free of cost to Bangladesh.
Also Read: Be humane in building livable society for differently-abled people: FM
These are expected to be shipped any day, Dr Momen said.
Poland donated these vaccine doses through the European Union (EU).
Pfizer asks FDA to OK COVID-19 booster shots for all adults
Pfizer asked U.S. regulators Tuesday to allow boosters of its COVID-19 vaccine for anyone 18 or older, a step that comes amid concern about increased spread of the coronavirus with holiday travel and gatherings.
Older Americans and other groups particularly vulnerable to the virus have had access to a third dose of the Pfizer and BioNTech vaccine since September. But the Food and Drug Administration has said it would move quickly to expand boosters to younger ages if warranted.
Pfizer is submitting early results of a booster study in 10,000 people to make its case that it’s time to further expand the booster campaign.
Also Read: Pfizer says COVID-19 pill cut hospital, death risk by 90%
While all three vaccines used in the U.S. continue to offer strong protection against severe COVID-19 illness and death, the shots’ effectiveness against milder infection can wane over time.
Pfizer’s new study concluded a booster could restore protection against symptomatic infection to about 95%, even as the extra-contagious delta variant was surging. Side effects were similar to those seen with the company’s first two shots.
A median of 11 months after their last Pfizer vaccination, trial participants were given either a third dose or a dummy shot. Researchers tracked any infections that occurred at least a week later, and so far have counted five cases of symptomatic COVID-19 among booster recipients compared to 109 cases among people who got dummy shots.
The Biden administration had originally envisioned boosters for all adults, but faced a stinging setback in September when the FDA’s scientific advisers rejected extra Pfizer doses for everyone. The panel wasn’t convinced that young healthy people needed another dose, particularly when most of the world’s population remains unvaccinated, and instead recommended boosters just for certain groups — one of a series of decisions about extra doses for all of the three vaccines used in the U.S.
Also Read: FDA paves way for Pfizer COVID-19 vaccinations in young kids
The current rules: People who initially received Pfizer or Moderna vaccinations are eligible for a booster six months later if they’re 65 or older, or are at high risk of COVID-19 because of health problems or their job or living conditions. Because the single-dose Johnson & Johnson vaccine hasn’t proven as effective as its two-dose competitors, any J&J recipient can get a booster at least two months later.
Also, anyone eligible for a booster doesn’t have to stick with their initial vaccination type and can get a different company’s vaccine, what’s called mixing and matching.
About 194 million Americans are fully vaccinated. Under today’s policies, authorities already estimated about 2 of every 3 vaccinated adults could qualify for a booster within the next few months. Many who don’t meet the criteria often score an extra shot because many vaccine providers don’t check qualifications.
FDA spokeswoman Alison Hunt said the agency would review Pfizer’s application “as expeditiously as possible,” but would not set a timeline for a decision. She also said the FDA hasn’t yet decided whether to convene its panel of outside experts to vet the data.
If the FDA authorizes Pfizer’s request for expanded boosters, the Centers for Disease Control and Prevention then will make recommendations for how to use them.
Globally, boosters also are a hodge-podge. Some countries restrict them to older or medically fragile people while others have few restrictions. Israel, for example, has allowed Pfizer boosters for anyone 12 and older. Canada’s health regulator on Tuesday authorized Pfizer boosters for people 18 and older.
Also Read: World could return to normal within a year: Pfizer CEO