Vaccine
AIIMS to begin Phase 2/3 trials of Bharat Biotech’s nasal Covid-19 vaccine within couple of weeks: Reports
Phase 2/3 trials of Bharat Biotech International Limited’s nasal vaccine against the coronavirus disease (Covid-19) are likely to begin “within a couple of weeks” at the All India Institute of Medical Sciences (AIIMS) in Delhi, reported Hidustan Times. The Hyderabad-based company received regulatory approvals to conduct the second and third phase trials of the intranasal vaccine, BBV154, in August.
For these two stages, mandatory permission from AIIMS Ethics Committee will be required for which an application has already been submitted. Upon receiving the panel’s nod, the exercise will be conducted by administering two doses to volunteers, with a gap of four weeks between the two.
The trials will take place under the leadership of Dr Sanjay Rai. The third phase will commence only after the preceding stage has been fully completed.
Also read: India’s Bharat Biotech says vaccine 93.4% effective against severe COVID-19
It is to be noted that BBV154 is the first of its kind Covid-19 jab to undergo human trials in the country. Phase 1 of the exercise was conducted on health groups volunteers in the age group of 18-60 and was “well tolerated,” the ministry of science and technology had said earlier. The vaccine has been developed with support from the department of biotechnology (DBT) and Biotechnology Industry Research Associate Council (BIRAC).
BBV154 is the first intranasal jab in the country to reach late-stage trials, according to Dr Renu Swarup, secretary, DBT.
Bharat Biotech has also developed India’s first home-made anti-Covid shot, Covaxin, which, along with Covishield, is the most-widely used vaccine in the nationwide inoculation drive, which began on January 16. In its Phase 3 clinical trials, Covaxin demonstrated 77.8% efficacy against symptomatic Covid-19 and 93.4% against severe form of the disease.
Also read: India may firm up plans to export Bharat Biotech’s Covaxin
Dhaka seeks unity against vaccine inequity to accelerate economic recovery efforts
Foreign Minister Dr AK Abdul Momen has said a successful pandemic recovery must involve universal vaccination ending vaccine inequality.
He referred to the unfortunate manifestation of vaccine nationalism and called the world to stand united against such vaccine inequity.
“It’s time for development partners to be more humane and help the deserving without discrimination. Vaccine should be a public good,” said the Foreign Minister while speaking at the United Nations high-level Forum on the Culture of Peace held at the United Nations General Assembly on Tuesday.
This year’s high-level Forum on the Culture of Peace focused on the transformative role of the Culture of peace in promoting inclusion and resilience in the post Covid recovery. The daylong event included an inaugural session, a plenary session and a virtual panel discussion.
“An essential component of our recovery effort from the pandemic must involve a peaceful environment in which all of us irrespective of our caste, creed, colour, race and religion can meaningfully contribute to our re-building efforts. There is no alternative to inculcate the Culture of Peace in our efforts to build back better in the post-Covid recovery,” Dr Momen said.
The Foreign Minister recalled Bangladesh’s pioneering role in the adoption of the UN General Assembly Resolution on the Culture of Peace since 1999 and organization of the high-level forum since 2012.
Read: 'Vaccine inequity' concerns IMF, WB, WHO, WTO
Apart from the Foreign Minister, the President of the General Assembly, High Representative of UN Alliance of Civilization, Chef de Cabinet of UN Secretary General and the Representative of UNESCO delivered remarks at the inaugural session.
Overwhelming registration causing delays in vaccine SMS : DGHS
The Department of Health on Wednesday said that the delays in getting vaccine SMS are being caused by high number of registrations in the country.Prof. Dr. Md. Nazmul Islam, spokesperson of the Directorate General of Health Services, said this in the daily health bulletin.“In most cases, the number of people registering is way more than the capacity of the vaccination centres in a given day.” he said.“We are trying our best to solve the problems. I am optimistic that we can deliver good news regarding this very soon,” he added.
READ: Quader trashes Fakhrul’s vaccine corruption allegation
“The Covid positivity rate has been below 10 per cent for the last four days. Our expectation is that if it goes down further, we can resume our normal life again,” the spokesperson hoped.Responding to a question regarding production of vaccines in Bangladesh, he said,” According to a contract signed between Incepta Pharmaceuticals and Sinopharm, the vaccine will be processed in Bangladesh.”“ The company (Incepta) wanted time. They said it’ll take around 3 months for them to complete the groundwork. We are looking forward to receiving positive news from them,” he added.He informed that a total of 3, 15,97,320 people have received Covid jabs in Bangladesh.
READ: EU promises 10mn Covid-19 vaccine doses for Bangladesh Of them 1,17,56,28 people have got double doses while 1,98,41,292 people received a single dose so far.
KiK collaborates with BGMEA to finance vaccines for RMG workers
Renowned German brand KiK has donated to purchase Covid-19 vaccines for garment workers in Bangladesh.
The donation was made through BGMEA which will be forwarded to the Ministry of Health and Family Welfare as the government is responsible for procuring and administering vaccines.
The donation comes as part of KiK’s social responsibility as a long-standing partner of the garment industry in Bangladesh.
In addition to sourcing garments, KiK has been involved with social projects in Bangladesh for many years and established a number of charitable organizations like schools and medical stations.
"As a result of our many years of close cooperation, we became very aware of the impact of the Corona pandemic on the country and the garment industry in particular," said Patrick Zahn, CEO KiK, the motivation behind the donation.
READ: BGMEA continues supporting Covid dedicated hospitals
People in this industry work indoors, where they are at increased risk of infections.
"For me, there’s no doubt that vaccination is the best protection against the Corona virus. With our donation, we want to make a contribution to ensure that people in the garment industry in Bangladesh are protected in the best possible way," said the CEO.
BGMEA President Faruque Hassan praised the initiative of the German brand.
He said the garment industry serves as the most important pillar of Bangladesh economy and the sector has suffered tremendously from the effects of the COVID pandemic and continues to do so to this day.
"To protect the entire economy of the country, it is crucial that workers and employees in this industry can be offered a vaccine. Thanks to the generous donation of the German company KiK, we are able to procure and vaccinate thousands of RMG workers in Bangladesh."
Earlier, BGMEA requested the government to bring garment workers under vaccination on a priority basis, considering them as frontliners.
As a result, the government of Bangladesh launched the vaccination programme for the RMG workers in July this year which is going on now.
READ: BGMEA, Evercare sign deal on BIG4 Initiative
BGMEA expressed sincere thanks and gratitude to Prime Minister Sheikh Hasina for considering the garment workers under Covid-19 vaccination on a priority basis as they have been doing their jobs amid the pandemic to protect the economy of the country.
Decision on vaccinating school students soon: DGHS DG
A decision will be taken soon whether school students will be vaccinated against Covid-19, said Prof Abul Bashar Mohammad Khurshid Alam, Director General (DG) of the Directorate General of Health Services (DGHS).
“The decision is likely to be taken tomorrow (Thursday) at a high-profile meeting of government officials,” he told reporters on Wednesday.
The Prime Minister wants to bring school children under vaccination coverage, he said, adding that no guideline has been received yet from the World Health Organization (WHO) in this regard.
The children in the USA are being vaccinated following a protocol and the same can be done here, Prof Khurshid Alam added.
READ: DU asks students to provide their vaccination status
“The vaccination of teachers is almost done in Bangladesh. University students have also been vaccinated,” said the DGHS DG.
EPI staff suspended for pushing Covid vaccine at home
Health authorities have suspended a staff (vaccine carrier) of Expanded Programme on Immunization (EPI) in North Matlab upazila in Chandpur district for pushing Covid-19 jabs at receivers’ homes.
The suspended staff is Mohammad Jakir Mia, 40, upazila health and family planning officer Nusrat Jahan Mithen told UNB.
READ: Sirajganj UP chairman suspended on graft charge
The staff was accused of pushing Covid jabs to people at their homes in Moradon and Thakurchar villages on August 19 and 22 respectively in exchange of money defying the rules of the health department, she said.
As per the directive of Civil Surgeon Dr M Shakawatullah a 3-member probe committee was formed with medical officer of the upazila health complex Dr Mainul Islam Monas as the convener. The committee found his involvement in the irregularities in its investigation.
READ: BIWTC officer suspended for not wearing mask
Govt inks Tk 10.5-crore vaccine deal with WHO: Health Minister
The government signed a new vaccine procurement deal of Tk 10.5 crore with the World Health Organization(WHO) in an effort to ensure Covid-19 vaccine for all, said Health Minister Zahid Maleque on Sunday.
The minister was speaking at a programme organised by sadar upazila Jubo League in Manikganj to observe the National Mourning marking August 15 massacre.
In another virtual program on Sunday, the minister said that doctors are doing their duties properly during the Covid situation and his ministry is just assisting them.
READ: Vaccine sharing: Dhaka wants EU to be more generous
“Even in this situation the country’s growth rate is within 6 which means Covid situation here is still under our control”, said the minister.
Many developed countries have failed in controlling the Covid crisis as people died on roads but Bangladesh didn’t face that scenario, he said.
READ: Bangladesh to receive 10 lakh Pfizer vaccine jabs on Aug 30: Minister
He said educational institutions will be reopened soon after all students and teachers get Covid jabs.
Vaccine sharing: Dhaka wants EU to be more generous
The European Union (EU) should be more generous in sharing Covid-19 vaccines with others who need them badly, Foreign Minister Dr AK Abdul Momen said Thursday.
Although the EU talks much about human rights, it cares little about it when it comes to vaccine sharing, he said.
"We expect the EU to be more generous," the minister told reporters while referring to the fact that European countries are letting thousands of Covid-19 vaccine doses expire.
Read: Bangladesh to receive 60 lakh more Pfizer vaccine doses in Aug: Minister
However, Dr Momen said Bangladesh will soon receive more vaccine doses from the US.
The country will receive 10 lakh doses of Pfizer vaccine on August 30.
Also, the foreign minister said he will leave Dhaka on August 28 to attend a series of programmes in Geneva, Switzerland, the Netherlands and hold important meetings in London during his stopover there.
Read: US regulators give full approval to Pfizer COVID-19 vaccine
On the Afghanistan issue, Dr Momen said Bangladesh is keeping close tabs on the situation and the Bangladesh Embassy in Uzbekistan is in touch with Bangladeshis who are willing to return.
Talking about his recent South Sudan and South Africa visit, the minister said it was very useful and successful.
India may be entering endemic stage of Covid: WHO
Covid-19 in India may be entering some kind of stage of endemicity with a low or moderate level of transmission going on, according to the chief scientist of the UN health agency.
The endemic stage is when a population learns to live with a virus. It is very different to the epidemic stage when the virus overwhelms a population.
Read:India gives emergency approval for world's first COVID-19 DNA vaccine
"As far as India is concerned that seems to be what is happening and because of the size of India and heterogeneity of population and immunity status in different parts of the country in different pockets. It is very feasible that the situation may continue like this with ups and downs in different parts of the country, particularly where there are more susceptible populations," World Health Organisation (WHO) Chief Scientist Dr Soumya Swaminathan said in an interview Wednesday.
"We may be entering some kind of stage of endemicity where low-level transmission or moderate level transmission is going on but we are not seeing the kinds of exponential growth and peaks that we saw a few months ago," Swaminathan said.
During April-May this year, India witnessed a devastating second wave of the Covid-19 pandemic.
Read:'India likely to have Covid shot for children by September'
"I hope by the end of 2022, we will be in that position that we have achieved vaccine coverage, say 70%, and then countries can get back to normal, " Swaminathan said.
"Although it is possible that children could get infected in a third wave in large numbers, it is very unlikely that they will fall seriously ill. However, it is advisable to be prepared for more infections in children," the WHO chief scientist said.
US regulators give full approval to Pfizer COVID-19 vaccine
The U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday, a milestone that could boost public confidence in the shots and spur more companies, universities and local governments to make vaccinations mandatory.
The Pentagon immediately announced it will press ahead with plans to require members of the military to get the vaccine as the U.S., and the world, battle the extra-contagious delta variant.
The formula made by Pfizer and its German partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot’s safety. More than 200 million Pfizer doses have been administered in the U.S. — and hundreds of millions more worldwide — under special emergency provisions since December.
Pfizer said the U.S. is the first country to grant the company’s vaccine full approval. The shot will be marketed in the U.S. under the brand name Comirnaty.
Moderna has also applied to the FDA for full approval of its vaccine. Johnson & Johnson, maker of the third option in the U.S., said it hopes to do so later this year.
Just over half of the U.S. population is fully vaccinated. Vaccinations in this country bottomed out in July at an average of about a half-million shots per day, down from a peak of 3.4 million a day in mid-April. As the delta variant fills hospital beds, shots are on the rise again, with a million a day given Thursday, Friday and Saturday.
Full approval of Pfizer’s COVID-19 vaccine means it meets the same “very high standards required of all the approved vaccines we rely on every day,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. That should help “anyone who still has concerns gain confidence” in the shots.
Earlier this month, Defense Secretary Lloyd Austin said he would seek the president’s OK to make the vaccine mandatory by mid-September or once the FDA grants final approval, whichever comes first. On Monday, after the FDA acted, the Pentagon said guidance on vaccinations will be worked out and a timeline will be provided in the coming days.
The FDA’s action may also lead to more vaccine mandates covering students, employees and customers.
READ: Pfizer to discuss vaccine booster with US officials Monday
“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”
This month, New York City, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, President Joe Biden is requiring government workers to sign forms attesting that they have been vaccinated or else submit to regular testing and other requirements.
Anxious Americans increasingly are on board: Close to 6 in 10 favor requiring people to be fully vaccinated to fly or attend crowded public events, according to a recent poll by The Associated Press-NORC Center for Public Affairs Research.
The delta variant has sent cases, deaths and hospitalizations soaring in recent weeks in the U.S., erasing months of progress. Deaths are running at about 1,000 a day on average for the first time since mid-March, and new cases are averaging 147,000 a day, a level last seen at the end of January.
“For weeks we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected,” said Dr. Tomas J. Aragon, director of California’s public health department. “If you are not vaccinated, let this be the milestone that gets you there.”
READ: Bangladesh to receive 60 lakh more Pfizer vaccine doses in Aug: Minister
The FDA, like regulators in Europe and much of the rest of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the time period when serious side effects typically arise.
That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence in deciding whether to fully license the vaccine for people 16 and older, those studied the longest. Pfizer’s shot is still being dispensed to 12- to 15-year-olds on an emergency basis.
Normally, doctors can prescribe FDA-approved products for other reasons than their original use. But Woodcock strongly warned that the Pfizer vaccine should not be used “off-label” for children under 12.
Both Pfizer and Moderna have vaccine studies underway in youngsters, and they are using different doses from what is available for those 12 and older. Results are expected in the fall.
Also, Woodcock said health providers are offering COVID-19 vaccines under agreements with the government that should preclude using Monday’s approval as a pretext for offering booster shots to the general population.
Currently, the FDA has authorized third doses of either Pfizer’s or Moderna’s vaccine only for certain people with severely weakened immune systems, such as organ transplant recipients. For everyone else, the Biden administration is planning for boosters starting in the fall. But the FDA is evaluating that question separately.
In reaching Monday’s decision, the FDA said safety tracking of millions of doses found serious side effects remain extremely rare, such as chest pain and heart inflammation a few days after the second dose, mostly in young men.
As for effectiveness, six months into Pfizer’s original study, the vaccine remained 97% protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.
Those findings came before the delta variant began spreading, but other data from the Centers for Disease Control and Prevention shows the vaccine is still doing a good job preventing severe disease caused by that mutant.