Moderna
US OK’d extra Covid vaccine dose for those with weak immune systems
U.S. regulators say transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge.
The late-night announcement Thursday by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations.
It’s harder for vaccines to rev up an immune system suppressed by certain medications and diseases, so those patients don’t always get the same protection as otherwise healthy people — and small studies suggest for at least some, an extra dose may be the solution.
Also read: The link between the COVID-19 vaccine and pregnancy
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement.
The FDA determined that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot. The FDA made no mention of immune-compromised patients who received the single-dose Johnson & Johnson vaccine.
The announcement comes as the extra-contagious delta version of the coronavirus surges through much of the country, pushing new cases, hospitalizations and deaths to heights not seen since last winter.
Importantly, the FDA’s decision only applies to this high-risk group, estimated to be no more than 3% of U.S. adults. It’s not an opening for booster doses for the general population.
Also read: Moderna says vaccine 93% effective but seeks 3rd-shot in fall
Instead, health authorities consider the extra dose part of the initial prescription for the immune-compromised. For example, France since April has encouraged that such patients get a third dose four weeks after their regular second shot. Israel and Germany also recently began recommending a third dose of two-dose vaccines.
Separately, U.S. health officials are continuing to closely monitor if and when average people’s immunity wanes enough to require boosters for everyone — but for now, the vaccines continue to offer robust protection for the general population.
The Centers for Disease Control and Prevention is expected to formally recommend the extra shots for certain immune-compromised groups after a meeting Friday of its outside advisers.
Transplant recipients and others with suppressed immune systems know they’re at more risk than the average American and some have been seeking out extra doses on their own, even if it means lying about their vaccination status. The change means now the high-risk groups can more easily get another shot — but experts caution it’s not yet clear exactly who should.
“This is all going to be very personalized,” cautioned Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who is running a major National Institutes of Health study of extra shots for organ recipients. For some people, a third dose “increases their immune response. Yet for some people it does not seem to. We don’t quite know who’s who yet.”
One recent study of more than 650 transplant recipients found just over half harbored virus-fighting antibodies after two doses of the Pfizer or Moderna vaccines — although generally less than in otherwise healthy vaccinated people. Another study of people with rheumatoid arthritis and similar autoimmune diseases found only those who use particular medications have very poor vaccine responses.
There’s little data on how well a third dose works, and if it causes any safety problems such as an increased risk of organ rejection. Wednesday, Canadian researchers reported that transplant recipients were more likely to have high levels of antibodies if they got a third dose than those given a dummy shot for comparison. Other small studies have similarly found that some transplant recipients respond to a third dose while others still lack enough protection.
DGHS decides to halt first dose of Moderna jabs after Aug 12
In a bid to ensure the second dose of Moderna Covid vaccine, the government has decided to halt administering its first dose after August 12.
The Department of Health Services has issued the notice after getting approval from the Director General of the Directorate General of Health Services (DGHS) on Tuesday.
According to the notice, the administering of the first dose of Moderna vaccine will be suspended after Aug. 12 across the country.
Also read: Mass inoculation to restart Monday with Sinopharm, Tuesday with Moderna: DGHS
But in centres where the first dose of vaccine remains in stock the second dose will begin after the stock finishes.
The second doses will be sent to the vaccination centres as per the quantity soon, it said.
Besides, it also asked to start administering the second dose of Sinopharm from August 14.
The authorities concerned have been asked to take necessary steps in this regard.
Also read: Mega Covid inoculation drive begins in Bangladesh
As the ruthless Delta variant of Covid-19 keeps rising, Bangladesh on Saturday kicked off another phase of its mass vaccination drawing huge response.
With a fresh stock of vaccine doses in hand, the government’s aim is to inoculate 80% of its population, with each getting two doses administered.
Moderna says vaccine 93% effective but seeks 3rd-shot in fall
Moderna Inc said its Covid-19 vaccine remained 93% effective through six months after the second shot but pointed to the likelihood of the need for a third-dose booster in the fall.
The company attributed the need for a booster shot to what it calls "increased force of infection" resulting from the highly contagious Delta variant that is expected to push up the number of breakthrough infections in vaccinated individuals.
"We are pleased that our Covid-19 vaccine is showing durable efficacy of 93% through six months, but recognise that the Delta variant is a significant new threat," Moderna CEO Stephane Bancel said Thursday as the company reported its second-quarter earnings and revenue.
Read: 11 billion-plus doses needed to vaccinate 70% people: Guterres
Antibody levels are expected to "continue to wane and eventually impact vaccine efficacy," which leads to the view that a third booster shot will likely be necessary before the winter season," the Massachusetts-based firm said.
Moderna's vaccine, which uses a new technology known as messenger RNA, was the second type of two-dose vaccines that were granted emergency use authorisation by the US drug regulator in December last year.
The company's latest analysis of a clinical trial showed the vaccine had a 93.2% efficacy against Covid-19, the respiratory illness caused by the virus, and 98.2% efficacy against severe symptoms, with no deaths reported.
Read: Bangladesh to procure 6 crore Sinopharm vaccine doses: Minister
But the data does not include the vaccine's performance against the Delta variant, first detected in India.
So far, Bangladesh has administered at least 14,733,314 doses of Covid vaccines – including 110,1897 Moderna shots.
There are many variants of SARS-CoV-2 that can cause Covid. Each variant is the result of a random mutation of the original virus.
The main variant of concern now in Bangladesh, and indeed worldwide, is the Delta variant. This variant spreads more quickly than the original virus, increasing the number of hospitalisations or deaths.
Chattogram receives 2.6 lakh jabs ahead of vaccination push
Chattogram has received another 2,66,400 doses of covid vaccine on Friday morning as the nationwide vaccination drive is set to get a push on Saturday.
Of the 2,66,400 doses of vaccine received here, 38,400 doses are of Moderna, USA, 1,20,000 are of China’s Sinopharm and 1,80,000 are of Oxford-AstraZeneca.
Civil Surgeon of the district Dr Sheikh Fazle Rabbi along with the local vaccine committee members received the vaccine doses around 7am.
Read: People find 'easy excuses' to defy lockdown in Dhaka
The civil surgeon said the vaccine doses were stored in the central cold storage of the civil surgeon's office. These doses will be supplied to vaccination centres as per their demand.
Among the vaccine doses, AstraZeneca jabs are for the second dose, Moderna for the ward-based mass vaccination programme and Sinopharm for the union level in upazilas, said Dr Rabbi.
Some 4,53,760 people in Chattogram took the first dose of the Oxford-AstraZeneca vaccine. As many as 1,05,425 people who took the first dose have been waiting for their second doses as many have already passed four months since taking the first doses.
Read: Covid kills 218 more in Bangladesh as its catastrophe continues
Earlier, Chattogram received 1,84,000 doses of Sinopharm and Moderna vaccine on July 11 and 1,85,000 doses on July 28.
During the last week, Bangladesh administered around 307,614 doses on average a day. At that pace, it will take 107 more days to administer enough doses for another 10% of the population here.
So far, since the inauguration of mass inoculation in Bangladesh on February 7 this year, some 4,416,131 people have fully been vaccinated with two shots while 10,009,953 have received the first doses, says the DG of the DGHS.
What is a COVID-19 vaccine “breakthrough” case?
It’s when a fully vaccinated person gets infected with the coronavirus. A small number of such cases are expected and health officials say they’re not a cause for alarm.
COVID-19 vaccines work by teaching the body to recognize the virus. So if you’re exposed to it after vaccination, your immune system should be ready to spring into action and fight it.
In studies, the two-dose COVID-19 vaccines by Pfizer and Moderna were around 95% effective at preventing illness, while the one-shot Johnson & Johnson shot was 72% effective, though direct comparisons are difficult. So while the vaccines are very good at protecting us from the virus, it’s still possible to get infected with mild or no symptoms, or even to get sick.
Also read: Challenges remain despite Europe meeting 70 pct vaccine delivery goal
If you do end up getting sick despite vaccination, experts say the shots are very good at reducing the severity of the illness — the main reason to get vaccinated.
Most people with breakthrough infections experience mild illness, said Dr. William Moss, a vaccine expert at the Johns Hopkins Bloomberg School of Public Health.
In the U.S., people who weren’t vaccinated make up nearly all hospitalizations and deaths from COVID-19.
It’s difficult to determine why any particular breakthrough case happens. How much of the virus you’re exposed to could be a factor, Moss said. Our individual immune systems will also affect how well we respond to the shots. Some people, for example, have health conditions or take medications that could make their immune systems less responsive to the vaccines.
People might also have been exposed to the virus before the shots took full effect. Though less likely, they may have received a dose that was improperly stored or administered, Moss said.
Also read: Immunized but banned: EU says not all COVID vaccines equal
The Centers for Disease Control and Prevention notes variants could be factors in some breakthrough cases, though evidence so far indicates the vaccines used in the U.S. are protective against them.
Health officials are also watching for signs that breakthrough cases are rising, which could signal that protection from the vaccines is fading and boosters are needed.
3 mn more Moderna vaccine jabs reach Bangladesh
Foreign Minister Dr AK Abdul Momen on Monday night received three million doses of Moderna vaccine from the United States under COVAX facility as the government is trying to speed up the nationwide vaccination drive further.
Health and Family Welfare Minister Zahid Maleque, Charge d’ Affaires at US Embassy in Dhaka JoAnne Wagner, , Health Secretary Lokman Hossain Miah and other high officials of the government were also present to receive the vaccine doses.
Dr Momen thanked US President Joe Biden and his Administration for coming forward with the vaccines.
"It came at a time when we need it very badly. We're thankful to the US government for supporting us," he told reporters after receiving the vaccine consignment.
Dr Momen said COVID-19 is a global challenge and all need to work in partnership and in collaboration to face this challenge.
He said Prime Minister Sheikh Hasina declared that vaccines should be public good and shared by all the countries without any discrimination.
Earlier, a special flight of Qatar Airways landed at Hazrat Shahjalal International Airport at around 9:06 pm carrying the vaccine doses.
Also read: 'It's just the beginning': US ambassador on Moderna shipment's arrival
Bangladesh already received the first consignment of 2.5 million doses of Moderna vaccine under the COVAX facility.
Bangladesh to receive 3 mn doses of Moderna vaccine Monday
Bangladesh will receive a consignment of Moderna vaccine doses on Monday evening.
The 3 million vaccine doses from the USA under COVAX facility are expected to reach at 7:20pm at Hazrat Shahjalal International Airport.
Also read: 'It's just the beginning': US ambassador on Moderna shipment's arrival
Health Minister Zahid Maleque will remain present at the Airport.
Earlier, US Ambassador to Bangladesh Earl Miller announced that Bangladesh will receive 3 million doses of Moderna vaccine under the COVAX facility.
Bangladesh to get another three million doses of Moderna Covid jabs: US envoy
US Ambassador Earl R Miller has announced another consignment of three million doses of Moderna's Covid-19 vaccine for Bangladesh.
These vaccine doses are coming to Bangladesh from the American people via the COVAX facility, he said.
"The US is committed to increasing the country’s vaccine supply to beat the pandemic here and worldwide," Ambassador Miller tweeted.
READ: Bangladesh’s request for vaccine doses under active consideration: Miller
In the first week of July, Bangladesh received the first consignment of 2.5 million doses of the Moderna vaccine under the COVAX facility.
Meanwhile, Bangladesh will receive 20 lakh doses of the Sinopharm vaccine from China on Saturday night as part of a commercial agreement.
Deputy Chief of Mission at Chinese Embassy in Dhaka, Hualong Yan told UNB on Friday that the vaccine doses would arrive at Hazrat Shahjalal International Airport in two planes.
'It's just the beginning': US ambassador on Moderna shipment's arrival
US Ambassador to Bangladesh Earl R. Miller has said the arrival of 2.5 million doses of the US biotech firm Moderna's highly successful vaccine for Covid-19 through the COVAX facility is only the beginning.
"The United States understands the urgency of getting as many safe and effective vaccines to Bangladesh as quickly as possible," he said while addressing a reception at Hazrat Shahjalal International Airport on Friday night.
Earlier, Foreign Minister Dr AK Abdul Momen received the first consignment of 2.5 million doses of Moderna vaccine under the COVAX framework.
Health and Family Welfare Minister Zahid Maleque, Foreign Secretary Masud Bin Momen, Secretary of Health Services Division Lokman Hossain Miah, and other high officials of Bangladesh government were also present.
READ:Bangladesh receives 1st consignment of 2.5 million Moderna vaccine doses
The second consignment arrived on Saturday morning.
Ambassador Miller said the United States has been Bangladesh’s closest partner for the past five decades working to improve public health.
"Today, at this uniquely challenging moment in history, our partnership is more important than ever," he said.
Miller said he is proud to join with partners and leaders from the Government of Bangladesh to continue to work together to build a world safer and more secure against the threat of infectious disease.
READ:Bangladesh receives 1st consignment of 2mn doses of Sinopharm vaccine
"We do so for the people of Bangladesh, the people of America, for all people on this precious vulnerable world we are privileged and responsible to share and protect," said the US Ambassador.
Bangladesh to receive 2.5mn Moderna jabs from COVAX July 2-3: FM
Foreign Minister Dr AK Abdul Momen on Wednesday said Bangladesh will receive 2.5 million doses of Moderna Covid-19 vaccine under the COVAX facility in two consignments on July 2 and July 3 respectively.
The Foreign Minister also said the first consignment of 2 million doses of Sinopharm vaccine will arrive soon.
“I think complexities over vaccine supply are eased,” he told reporters at Foreign Service Academy after a programme.
Dr Momen said huge money has been allocated and there is nothing to be worried about vaccine purchase. “We shouldn’t have faced any problem.”
Earlier, Deputy Chief of Mission at Chinese Embassy in Dhaka Hualong Yan said the first consignment of 2 million doses of vaccine as part of Bangladesh government's commercial purchase from China's Sinopharm are ready for delivery in Beijing.
READ: Individuals having appointments to be allowed to go to foreign missions during lockdown: FM
"China stands by our Bangladeshi friends in fighting the new wave of the pandemic," he said.
Bangladesh is likely to get 1.5 crore of Sinopharm vaccine doses from China while China says it is ready to supply more, if needed.
Earlier, US Ambassador to Bangladesh Earl Miller tweeted saying Bangladesh will soon receive a gift of 2.5 million doses of Moderna Covid-19 vaccine from the American people via GAVI.
"As the largest contributor to COVAX, the U.S. is committed to increasing the country’s vaccine supply to beat the pandemic here and worldwide." Ambassador Miller said.
Bangladesh entered into a deal with the Serum Institute of India (SII) to purchase 30 million doses of a potential vaccine being developed by AstraZeneca for Covid-19.
Bangladesh was supposed to get five million doses of vaccine per month as the SII and Bangladesh’s Beximco Pharma signed the Memorandum of Understanding (MoU) for priority delivery of the vaccine doses.
Bangladesh has so far received only 7 million of Oxford-AstraZeneca covid-19 vaccine doses produced by Serum Institute of India (SII) through its contract. Bangladesh also received 3.3 million doses of vaccine as a bilateral partnership gift.
Regarding the national budget he said, an “optimistic budget” has been passed despite bad days due to Covid-19 situation with an expansion of the social safety net. “It has been proved again that Prime Minister Sheikh Hasina is a friend of the poor.”
Responding to a question on use of Myanmar’s SIM cards in Rohingya camps, Dr Momen said the government stopped 4G services in the camps to stop criminal activities and trafficking in person.
He, however, said they reintroduced it amid desperate efforts from the UNHCR and rights bodies.
The Foreign Minister said the government has had no direct communication with the Myanmar government since the military took over power there. “We’re observing the situation.”
READ: S Asian nations should receive vaccines without any strings attached: FM
Earlier, Dr Momen along with State Minister for Foreign Affairs Md Shahriar Alam spoke at the function marking the launching of Foreign Service Debating Club. Foreign Secretary Masud Bin Momen was also present.