Pfizer
Pfizer to seek OK for 3rd vaccine dose; shots still protect
Pfizer is about to seek U.S. authorization for a third dose of its COVID-19 vaccine, saying Thursday that another shot within 12 months could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant.
Research from multiple countries shows the Pfizer shot and other widely used COVID-19 vaccines offer strong protection against the highly contagious delta variant, which is spreading rapidly around the world and now accounts for most new U.S. infections.
Two doses of most vaccines are critical to develop high levels of virus-fighting antibodies against all versions of the coronavirus, not just the delta variant -- and most of the world still is desperate to get those initial protective doses as the pandemic continues to rage.
Also read: AstraZeneca, Pfizer vaccines effective against Delta Covid-19 variants: Study
But antibodies naturally wane over time, so studies also are underway to tell if and when boosters might be needed.
On Thursday, Pfizer’s Dr. Mikael Dolsten told The Associated Press that early data from the company’s booster study suggests people’s antibody levels jump five- to 10-fold after a third dose, compared to their second dose months earlier.
In August, Pfizer plans to ask the Food and Drug Administration for emergency authorization of a third dose, he sai.
Why might that matter for fighting the delta variant? Dolsten pointed to data from Britain and Israel showing the Pfizer vaccine “neutralizes the delta variant very well.” The assumption, he said, is that when antibodies drop low enough, the delta virus eventually could cause a mild infection before the immune system kicks back in.
But FDA authorization would be just a first step -- it wouldn’t automatically mean Americans get offered boosters, cautioned Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center. Public health authorities would have to decide if they’re really needed, especially since millions of people have no protection.
Also read: Bangladesh rolls out Pfizer vaccine at 3 Dhaka centers
“The vaccines were designed to keep us out of the hospital” and continue to do so despite the more contagious delta variant, he said. Giving another dose would be “a huge effort while we are at the moment striving to get people the first dose.”
Hours after Pfizer’s announcement, U.S. health officials issued a statement saying fully vaccinated Americans don’t need a booster yet.
U.S. health agencies “are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” the FDA and Centers for Disease Control and Prevention said in a joint statement. That work will include data from the drug companies, “but does not rely on those data exclusively,” and any decision on booster shots would happen only when “the science demonstrates that they are needed,” the agencies said.
Currently only about 48% of the U.S. population is fully vaccinated — and some parts of the country have far lower immunization rates, places where the delta variant is surging. On Thursday, Dr. Rochelle Walensky, the CDC director, said that’s leading to “two truths” — highly immunized swaths of America are getting back to normal while hospitalizations are rising in other places.
“This rapid rise is troubling,” she said: A few weeks ago the delta variant accounted for just over a quarter of new U.S. cases, but it now accounts for just over 50% — and in some places, such as parts of the Midwest, as much as 80%.
Also read: European regulators OK Pfizer vaccine for children 12-15
Also Thursday, researchers from France’s Pasteur Institute reported new evidence that full vaccination is critical.
In laboratory tests, blood from several dozen people given their first dose of the Pfizer or AstraZeneca vaccines “barely inhibited” the delta variant, the team reported in the journal Nature. But weeks after getting their second dose, nearly all had what researchers deemed an immune boost strong enough to neutralize the delta variant — even if it was a little less potent than against earlier versions of the virus.
The French researchers also tested unvaccinated people who had survived a bout of the coronavirus, and found their antibodies were four-fold less potent against the new mutant. But a single vaccine dose dramatically boosted their antibody levels — sparking cross-protection against the delta variant and two other mutants, the study found. That supports public health recommendations that COVID-19 survivors get vaccinated rather than relying on natural immunity.
The lab experiments add to real-world data that the delta variant’s mutations aren’t evading the vaccines most widely used in Western countries, but underscore that it’s crucial to get more of the world immunized before the virus evolves even more.
Researchers in Britain found two doses of the Pfizer vaccine, for example, are 96% protective against hospitalization with the delta variant and 88% effective against symptomatic infection. That finding was echoed last weekend by Canadian researchers, while a report from Israel suggested protection against mild delta infection may have dipped lower, to 64%.
Whether the fully vaccinated still need to wear masks in places where the delta variant is surging is a growing question. In the U.S., the CDC maintains that fully vaccinated people don’t need to. Even before the delta variant came along, the vaccines weren’t perfect, but the best evidence suggests that if vaccinated people nonetheless get the coronavirus, they’ll have much milder cases.
“Let me emphasize, if you were vaccinated, you have a very high degree of protection,” Dr. Anthony Fauci, the U.S. government’s top infectious disease expert, said Thursday.
In the U.S., case rates have been rising for weeks and the rate of hospitalizations has started to tick up, rising 7% from the previous seven-day average, Walensky told reporters Thursday. However, deaths remain down on average, which some experts believe is at least partly due to high vaccination rates in people 65 and older — who are among the most susceptible to severe disease.
Can you mix and match Covid-19 vaccines?
Can you mix and match two-dose COVID-19 vaccines?
It’s likely safe and effective, but researchers are still gathering data to be sure.
The authorized COVID-19 shots around the world are all designed to stimulate your immune system to produce virus-fighting antibodies, though the way they do so varies, noted Dr. Kate O’Brien, director of the World Health Organization’s vaccine unit.
“Based on the basic principles of how vaccines work, we do think that the mix-and-match regimens are going to work,” she said.
Also read: Why do some people get side effects after COVID-19 vaccines?
Scientists at Oxford University in the United Kingdom are testing combinations of the two-dose COVID-19 vaccines made by AstraZeneca, Moderna, Novavax and Pfizer-BioNTech. Smaller trials are also ongoing in Spain and Germany.
“We really just need to get the evidence in each of these (vaccine) combinations,” O’Brien said.
So far, limited data suggests an AstraZeneca shot followed by the Pfizer shot is safe and effective. The combination also appears to come with a slightly higher likelihood of temporary side effects like aches and chills.
That might be because mixing and matching different types of vaccines can often produce a stronger immune response, said Lawrence Young, a virologist at the University of Warwick in the United Kingdom.
Also read: How long does protection from COVID-19 vaccines last?
In some places, health officials already suggest mixing in select circumstances.
After the AstraZeneca vaccine was linked to extremely rare blood clots, many European countries including Germany, France and Spain recommended people who got it as a first dose get a Pfizer or Moderna shot as a second dose instead.
In Britain and Canada, officials say people should aim to get the same vaccine for their second dose if possible. If they got AstraZeneca as their first shot, they’re advised to get another vaccine only if they have a history of blood clots or other conditions that might put them at higher risk of clots.
Pfizer, Sinopharm shots to start June 19: Health Minister
Bangladesh will start administering Sinopharm and Pfizer vaccine doses from June 19, Health Minister Zahid Maleque said on Monday.
“The vaccination drive will start with the number of vaccines available,” he said.
He also expressed worries over the deterioration of the pandemic situation in many places of the country.
Also read: Registered people will get Pfizer vaccine first, says health minister
“The situation is deteriorating in many places. People have to be aware. Hospital services will be disrupted if covid increases more as there is a shortage of hospital beds in some places,” he said.
“We have to emphasise more on prevention than cure,” he added.
A consignment of 600,000 doses of China’s Sinopharm jabs arrived here on Sunday, nine days after the arrival of the first batch of 500,000 doses gifted by Beijing.
Also read: Second consignment of Sinopharm vaccine arrives
Bangladesh has also received 100,620 doses of the Pfizer Covid-19 vaccine on June 1 .
The health minister earlier said that Pfizer vaccine shots will be given at four centres in Dhaka to those who have already registered.
Read Can I take COVID vaccines from two different brands?
AP source: US to buy 500M Pfizer vaccines to share globally
The U.S. will buy 500 million more doses of the Pfizer COVID-19 vaccine to share through the global COVAX alliance for donation to 92 lower income countries and the African Union over the next year, a person familiar with the matter said Wednesday.
President Joe Biden was set to make the announcement Thursday in a speech before the start of the Group of Seven summit. Two hundred million doses — enough to fully protect 100 million people — would be shared this year, with the balance to be donated in the first half of 2022, the person said.
National security adviser Jake Sullivan told reporters Wednesday that Biden was committed to sharing vaccines because it was in the public health and strategic interests of the U.S. As Biden embarks on his first foreign trip, he is aiming to show “that democracies are the countries that can best deliver solutions for people everywhere,” Sullivan said.
“As he said in his joint session (address), we were the ‘arsenal of democracy’ in World War II,” Sullivan said. “We’re going to be the ‘arsenal of vaccines’ over this next period to help end the pandemic.”
Also read: G7 must ensure vaccine access in developing countries: UN experts
The news of the Pfizer sharing plan was confirmed to The Associated Press by a person familiar with the matter, who spoke on condition of anonymity ahead of the president’s formal announcement. The news was first reported by the Washington Post.
The U.S. has faced mounting pressure to outline its global vaccine sharing plan. Inequities in supply around the world have become more pronounced, and the demand for shots in the U.S. — where nearly 64% of adults have received at least one dose — has dropped precipitously.
The announcement comes a week after the White House unveiled its plans to donate an initial allotment of 25 million doses of surplus vaccine overseas, mostly through the United Nations-backed COVAX program, promising infusions for South and Central America, Asia, Africa and others at a time of glaring shortages abroad.
Overall, the White House has announced plans to share 80 million doses globally by the end of June, most through COVAX. Officials say a quarter of the nation’s excess will be kept in reserve for emergencies and for the U.S. to share directly with allies and partners.
The White House has also directed doses to allies including South Korea, Taiwan and Ukraine.
Also read: WTO panel considers easing protections on COVID-19 vaccines
Global public health groups had been aiming to use the upcoming G-7 meetings in Cornwall, England, to press the nation’s wealthiest democracies to do more to share vaccines with the world, and Biden’s plans drew immediate praise toward that end.
“The Biden administration’s decision to purchase and donate additional COVID-19 vaccine doses is the kind of bold leadership that is needed to end this global pandemic,” said Tom Hart, acting CEO at The ONE Campaign, a nonprofit that seeks to end poverty. “This action sends an incredibly powerful message about America’s commitment to helping the world fight this pandemic and the immense power of US global leadership.”
Sullivan told reporters Wednesday that he does not expect the U.S. push to waive the patents on vaccines to cause tension with European counterparts.
“We’re all converging around the idea that we need to boost vaccine supply in a number of ways, sharing more of our own doses,” Sullivan told reporters aboard Air Force One. “We’ll have more to say on that, helping get more manufacturing capacity around the world.”
Globally, there have been more than 3.7 million confirmed deaths from COVID-19, and more than 174 million people have been confirmed infected.
Registered people will get Pfizer vaccine first, says health minister
Health Minister Zahid Maleque has said that Pfizer vaccine shots for Covid-19 will be given at four centres in Dhaka to those who have already registered.
He added that the Pfizer vaccine diluent will arrive here Monday night.
“Efforts are underway to collect Pfizer's dilute mixture. It's coming tonight. Those who have registered will get it first according to the serial,” he said on Monday.
Read: Bangladesh approves emergency use of Pfizer vaccine
The minister was talking to the reporters after a meeting at the BCPS Auditorium on the occasion of the National Vitamin 'A' Plus Campaign-2021.
Earlier on May 27 the government approved the emergency use of Pfizer Covid-19 vaccine in the country.
This is the fourth Covid-19 vaccine approved for emergency use in Bangladesh.
The first batch of 1.06 lakh doses of the Pfizer Covid-19 vaccine arrived in Dhaka on June 1 .
Read: 1 lakh-plus Pfizer vaccine doses reach Dhaka
The Pfizer-BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process.
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.
The US Food and Drug Administration has authorised the storage of the Pfizer Covid-19 vaccine at standard refrigerator temperatures for up to one month, to make the vaccine more widely available.
Read Russian Vaccine Sputnik V: Things we should know to fight COVID-19
Vaccination drive
Around 7,363 people have received the second dose of Oxford-AstraZeneca vaccine in the last 24 hours.
A total number of 42,16,696 people got their second dose of this vaccine while the number is 58,20,015 for the first dose.
Besides, the total number of people receiving their first jab of Chinese Sinopharm vaccine reached 2,162 during the same period.
Bangladesh launched its vaccination drive on February 7 with Oxford-AstraZeneca doses bought from India's Serum Institute.
Read Can I take COVID vaccines from two different brands?
US welcomes Pfizer arrival in Bangladesh; reiterates to work together
The United States has welcomed the arrival of 106,000 doses of the Pfizer/BioNTech’s Covid-19 vaccine to Bangladesh saying the US, Bangladesh and global partners are working closely together to combat this pandemic.
This shipment was made possible through the COVAX Advance Market Commitment, a global initiative to support equitable access to Covid-19 vaccines, said the US Embassy in Dhaka on Tuesday.
The United States recently announced an initial $2 billion obligation—of a total planned $4 billion—to GAVI, the Vaccine Alliance to support the COVAX Advance Market Commitment, making the United States the largest donor for equitable global Covid-19 vaccine access.
“The Covid-19 pandemic underscores that no nation can act alone against a global pandemic. The United States, Bangladesh, and global partners are working closely together to combat this pandemic,” said US Ambassador to Bangladesh Earl Miller.
“We’re committed to working shoulder to shoulder with the government of Bangladesh to get through this unprecedented global health crisis and put systems in place so we’re more prepared for and resilient in future crises.”
Also read: 1 lakh-plus Pfizer vaccine doses reach Dhaka
The US contributions to COVAX, through the US Agency for International Development (USAID), will support the purchase and delivery of safe and effective Covid-19 vaccines for the world’s most vulnerable and at-risk populations in 92 low- and middle-income countries.
This support is critical to controlling the pandemic, slowing the emergence of new variants, and helping restart the global economy, said the US.
READ: European regulators OK Pfizer vaccine for children 12-15
The United States has worked closely with Bangladesh to protect the health of Bangladeshis and strengthen the government’s response to Covid-19, contributing over $76 million to date in development and humanitarian assistance from USAID, the US Department of Defense (DOD), and the US Centers for Disease Control and Prevention (CDC).
This assistance helped Bangladesh save lives and treat infected individuals; strengthen testing capacity and surveillance; enhance case management and infection prevention and control practices; improve supply chain and logistics management systems; increase public knowledge; train medical professionals; and ensure an effective roll-out of the vaccination campaign.
Additional US Covid response assistance included supplying 100 state-of-the-art US-manufactured ventilators; gas analysers to allow Bangladesh to produce its own ventilators; and tens of thousands of pieces of locally-produced personal protective equipment (PPE) for frontline workers across Bangladesh.
1 lakh-plus Pfizer vaccine doses reach Dhaka
The first batch of 1.06 lakh doses of the Pfizer Covid-19 vaccine arrived in Dhaka Monday night under the global vaccine initiative Covax facility.
A regular flight of Emirates landed at Hazrat Shahjalal International Airport at 11:10pm with the doses and Md Shamsul Haque, a line director at the Directorate General of Health Services, received them, Dr Nasrin Akhter, a medical officer at the airport's health centre, confirmed.
COVAX, the facility set up by the World Health Organization and several non-profits to deliver Covid-19 vaccines to developing nations, is working in partnership with Unicef, developed and developing country vaccine manufacturers, the World Bank, and others.
READ: European regulators OK Pfizer vaccine for children 12-15
On May 27, the Directorate General of Drug Administration approved the emergency use of the Pfizer vaccine.
So far four vaccines – Oxford-AstraZeneca (Covishield), Sputnik-V, Sinopharm, and Pfizer-BioNTech – have got emergency use authorisation in the country.
The Pfizer-BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process.
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.
READ: COVID-19: Bangladesh to receive over 1 lakh Pfizer vaccine on Sunday
The US Food and Drug Administration has authorised the storage of the Pfizer Covid-19 vaccine at standard refrigerator temperatures for up to one month, to make the vaccine more widely available.
European regulators OK Pfizer vaccine for children 12-15
The European Medicines Agency on Friday recommended that the use of the coronavirus vaccine made by Pfizer and BioNTech be expanded to children ages 12 to 15, a decision that offers younger and less at-risk populations across the continent access to a COVID-19 shot for the first time.
The vaccine was the first one granted authorization across the European Union when it was licensed for use in anyone 16 and over in December. So far, about 173 million doses of the shot have been administered in the 27-nation bloc, about three quarters of the total given.
“Extending the protection of a safe and effective vaccine in this younger population is an important step forward in the fight against this pandemic,” said Marco Cavaleri, who heads the EMA body that reviewed the vaccine.
The EU regulator had received the necessary data to authorize the vaccine for younger teens and found it to be highly effective against infection, he said.
Also read: Bangladesh approves emergency use of Pfizer vaccine
In a study involving 2,000 adolescents in the United States, none of those who received the vaccine got COVID-19, compared with 16 in a control group who received a placebo, said Cavaleri.
“The vaccine was well tolerated and the side effect in this age group were very much similar (to) what we’ve seen in young adults and not raising major concern at this point in time,” he added.
The EMA decision needs to be rubber-stamped by the European Commission, and individual national regulators must decide whether the vaccine will be administered to children under 16.
The recommendation follows similar decisions by regulators in Canada and the U.S. last month, as rich countries slowly approach their vaccination targets for adults and look to immunize as many people as possible.
Also read: Britain yet to decide on Pfizer offer to vaccinate Olympians
Researchers will continue to monitor the shot’s long-term protection and safety in the children for another two years.
Most COVID-19 vaccines worldwide have been authorized for adults, who are at higher risk of severe disease and death from the coronavirus. But vaccinating children of all ages could be critical to stopping outbreaks, since some research has shown older children may play a role in spreading the virus even though they don’t typically fall seriously ill.
In the U.S., children represent about 14% of the country’s coronavirus cases and at least 316 have died, according to the American Academy of Pediatrics. Doctors have also identified a rare inflammatory syndrome in a very small proportion of children sickened by COVID-19.
Immunizing children against COVID-19 might also give authorities more confidence to reopen schools, as getting children to wear masks and engage in social distancing has been challenging at times.
Also read: Pfizer COVID-19 shot expanded to US children as young as 12
But the World Health Organization has criticized rich countries for moving on to vaccinate their younger and less at-risk populations, saying that the extremely limited number of COVID-19 vaccines should instead be shared with poor countries so they too can protect their health workers and those most vulnerable.
“I understand why some countries want to vaccinate their children and adolescents, but right now I urge them to reconsider and to instead donate vaccines to COVAX,” WHO chief Tedros Adhanom Ghebreyesus said earlier this month, referring to the U.N.-backed initiative to distribute vaccines fairly. Of the more than 1 billion COVID-19 shots administered globally, fewer than 2% have gone to poor countries.
Other vaccine makers also are studying whether their shots are safe and effective in children. Earlier this week, Moderna Inc. said its shot strongly protects children as young as 12; it said it would submit a request for emergency use authorization to the U.S. Food and Drug Administration next month. Another U.S. company, Novavax, has a COVID-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds.
Both Moderna and Pfizer-BioNTech have been testing their vaccines in children from age 11 down to six months; they get a lower dose than what teens and adults receive. China’s Sinovac has also submitted early data to the country’s regulators, hoping to prove its vaccine is safe in children as young as 3.
COVID-19: Bangladesh to receive over 1 lakh Pfizer vaccine on Sunday
A flight of Qatar Airlines carrying a consignment of 1,00,620 doses of the Pfizer Covid-19 vaccine will arrive here on Sunday.
A press release issued by the Health and Family Welfare Ministry confirmed it on Thursday.
Earlier today, Bangladesh approved the emergency use of Pfizer Covid-19 vaccine in the country.
Also read: Bangladesh approves emergency use of Pfizer vaccine
The Directorate General of Drug Administration (DGDA) issued a press release in this regard.
Recently two other vaccines , Sputnik V produced by Generium Joint Stock Company of Russia, and Sinopharm produced by Beijing Institute of Biological Products Co. Ltd of China got approval of DGDA for emergency use in Bangladesh.
Earlier on January 7, DGDA approved the emergency use of Covishield vaccine, also known as SARS Cov-2 AZD1222, Oxford/ AstraZeneca vaccine, produced by Serum Institute of India.
The Pfizer/BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process.
Also read: Bangladesh to get 106,000 doses of Pfizer vaccine on June 2: Health Ministry
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity, according to a BBC report.
The US Food and Drug Administration on Wednesday authorized storage of Pfizer Covid-19 vaccine at standard refrigerator temperatures for up to one month, in an effort to make the vaccine more widely available.
Bangladesh approves emergency use of Pfizer vaccine
The government of Bangladesh has approved the emergency use of Pfizer Covid-19 vaccine in the country.
Directorate General of Drug Administration (DGDA) issued a press release in this regard on Thursday.
This is the fourth Covid-19 vaccine approved for emergency use in Bangladesh.
Recently two other vaccines , Sputnik V produced by Generium Joint Stock Company of Russia, and Sinopharm produced by Beijing Institute of Biological Products Co. Ltd of China got approval of DGDA for emergency use in Bangladesh.
Earlier on January 7, DGDA approved the emergency use of Covishield vaccine, also known as SARS Cov-2 AZD1222, Oxford/ Astra zeneca vaccine, produced by Serum Institute of India.
Earlier on May 18, Health Minister Zahid Maleque said that the country will get at least 106,000 doses of the Pfizer vaccine under the Covax facility.
The Pfizer/BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process.
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity, according to a BBC report.
The US Food and Drug Administration on Wednesday authorized storage of Pfizer Covid-19 vaccine at standard refrigerator temperatures for up to one month, in an effort to make the vaccine more widely available.