The US Food and Drug Administration (FDA) on Monday authorized the use of the Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15 years old.
“This is a promising development in our fight against the virus,” said President Joe Biden.
“If you are a parent who wants to protect your child, or a teenager who is interested in getting vaccinated, today’s decision is a step closer to that goal.”
The FDA previously granted an emergency use authorization for the Pfizer-BioNTech vaccine to individuals aged 16 and older.
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the Covid-19 pandemic,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The FDA said some 1.5 million Covid-19 cases in individuals aged 11 to 17 years old have been reported to the US Centers for Disease Control and Prevention between March 1, 2020 and April 30, 2021.
The course of the disease is generally milder in children but they can pass it on to older, more vulnerable adults.
Pfizer and its partner BioNTech said in March that their two-dose vaccine regimen was shown to be safe and highly effective in a trial of 2,260 12 to 15 year olds.
Biden last week stressed the importance of expanding vaccinations to 12 to 15 year olds and said the authorities were “ready to move immediately” once the authorization came through.
Some 20,000 pharmacies around the country were ready to begin to vaccinate adolescents, he said, and doses will also be shipped to pediatricians.
Covid-19 vaccines from Moderna and Johnson & Johnson have also received emergency use authorizations from the FDA but only for individuals over the age of 18.
Acting FDA commissioner Janet Woodcock described Monday’s move as a “significant step in the fight against the Covid-19 pandemic.”
“Today’s action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Woodcock said in a statement.
“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our Covid-19 vaccine emergency use authorizations,” she added.
Europe’s medicines watchdog said Friday it was checking whether Covid-19 vaccines made by Pfizer/BioNTech and Moderna could be linked to rare cases of blood clotting, but there was no indication so far.
The European Medicines Agency last month linked two other EU-approved vaccines, one made by AstraZeneca and another by Johnson & Johnson, to rare but occasionally fatal clots, however it stressed the vaccines’ benefits in fighting the coronavirus pandemic outweighed the risks.
The EMA’s safety committee “is closely monitoring whether mRNA vaccines might also be linked to cases of rare, unusual blood clots with low blood platelets.”
“Following a review of reports of suspected side effects, the (committee) considers at this stage that there is no safety signal for the mRNA vaccines,” the Amsterdam-based EMA said.
US drugs giant Pfizer and its German partner BioNTech as well as the US-based pharmaceutical Moderna base their vaccines on mRNA genetic technology that trains the body to reproduce spike proteins, similar to that found on the coronavirus.
When exposed to the real virus later, the body recognises the spike proteins and is able to fight them off.
So far, only few cases of blood clots with low blood platelets have been reported among the users of the mRNA vaccines.
Compared to the millions of people who have been vaccinated with them, “these numbers are extremely low, and their frequency is lower than the one occurring in people who have not been vaccinated,” the EMA said.
“In addition, these cases do not seem to present the specific clinical pattern observed with Vaxzevria and COVID-19 Vaccine Janssen,” the EMA said, using the brand names for AstraZeneca and J&J’s vaccines.
“Overall, the current evidence does not suggest a causal relation,” the medicines watchdog said.
The EMA also announced it has started reviewing data on a British and US-made antibody to treat coronavirus patients, but that it was too early to rule on its risks and benefits.
The EMA started a “rolling review” of data on sotrovimab, a monoclonal antibody developed by Britain’s GlaxoSmithKline and Vir Biotechnology based out of California.
Sotrovimab is a monoclonal antibody, a type of protein that attaches to the spike protein of the coronavirus, reducing its ability to enter the body’s cells.
The rolling review is a precursor to accelerated authorisation for use within the 27-nation European Union.
The United States is expected to authorize the Pfizer-BioNTech Covid-19 vaccine for children age 12 and up by early next week, US media reported Monday.
Pfizer has applied for emergency use authorization for its Covid vaccine for children and teenagers between ages 12 and 15, according to CNN, citing a government official.
“The FDA will have to amend the emergency use authorization for the vaccine, but the process should be straightforward,” CNN reported.
The US Food and Drug Administration is expected to grant that approval by early next week. After the FDA decision, the Centers for Disease Control and Prevention advisory committee will meet to recommend how the vaccine should be used.
A spokeswoman for the FDA declined to give details on the approval timeline, telling The Washington Post: “We are working to review this request as quickly and transparently as possible.”
The Pfizer vaccine is currently authorized for people 16 and older in the United States.
The US pharmaceutical giant said in late March it had submitted data from a clinical trial of 2,260 12- to 15-year-olds that showed the vaccine was highly effective and well-tolerated.
Further testing on younger children is ongoing.
Moderna is conducting trials of its vaccine in teens, with results expected in the summer, as well as in younger children.
Johnson & Johnson is also planning pediatric trials for its vaccine.
Expanding vaccine authorization to include adolescents could open up the US mass vaccination program to millions more people.
The national vaccination rate peaked around April 11, according to official data, and although 55 percent of US adults now have had one or more doses, there’s still a long way to go to achieve population immunity against Covid.
The people most eager to get their shots have, for the most part, already rolled up their sleeves and done so.
But vaccine hesitancy remains a major obstacle: a large percentage of US adults don’t plan to get the shot and could potentially refuse to get their children vaccinated.
Among Republican voters, 29 percent say they will never take the vaccine, compared to five percent of Democrats and nine percent of independents, according to a recent survey by the Kaiser Family Foundation.
Cheap and easy to store, the AstraZeneca/Oxford vaccine approved by the British regulator on Wednesday has given a shot in the arm to the global fight against coronavirus.
Here are five facts about the much-anticipated vaccine.
– Practicality –
The AstraZeneca/Oxford vaccine has the major advantages of being inexpensive, costing about £2.50 ($3.40, 2.75 euros) per dose, and easy to store.
It can be kept at normal refrigerator temperatures of between two and eight degrees Celsius, making it ideal for large-scale vaccination programs.
By contrast, the Moderna vaccine needs to be stored at -20C, while the Pfizer/BioNTech product must be kept at -70C.
– Mutant strain –
The vaccine should be capable of fighting the new variant of the coronavirus responsible for a surge of cases in the United Kingdom, according to AstraZeneca chief executive Pascal Soriot.
“So far, we think the vaccine should remain effective. But we can’t be sure, so we’re going to test that,” he told the Sunday Times.
New versions are being developed just in case, he revealed, adding: “You have to get prepared.”
– British product –
The vaccine developed by British firm AstraZeneca, working alongside Oxford University, is the second to be approved by the independent Medicines and Healthcare products Regulatory Agency (MHRA).
The Pfizer/BioNTech vaccine has been deployed in Britain since December 8, with almost 800,000 receiving their first dose, according to British Prime Minister Boris Johnson.
His government is battling one of the world’s worst outbreaks, with more than 71,000 deaths so far of those testing positive for the disease.
Britain has ordered 100 million doses of the AstraZeneca/Oxford vaccine, 40 million of which will be available by the end of March, with vaccinations scheduled to begin on January 4.
AstraZeneca said it expects to be able to manufacture about three billion doses of its vaccine worldwide in 2021.
– Chimpanzees –
The vaccine is “virus-vectored”, meaning it is a version of a virus that normally infects chimpanzees and has been modified with a portion of the Covid-19 coronavirus called the “spike protein” to fire the immune system.
Once in human cells, the vaccine should help stimulate the production of antibodies that recognizee the virus.
The vaccine is “safe and effective”, according to data published by The Lancet medical journal on December 8, with only one of the of the 23,754 volunteers who participated in the trials experiencing “possibly-related severe side effects”.
This was a case of rare neurological condition transverse myelitis that forced the temporary suspension of trials.
– Result Confusion-
The British laboratory announced in interim findings in November that its vaccine was on average 70 percent effective, compared with more than 90 percent for Pfizer/BioNTech and Moderna.
The efficacy of the AstraZeneca/Oxford vaccine was 90 percent for volunteers who first received only a half-dose and then a full dose one month later, but only 62 percent for another group that was vaccinated with two full doses one month apart.
The injection of a half-dose was conducted by accident, raising criticism over the robustness of the results and prompting the company to announce on November 26 that an “additional study” would be held into the efficacy of the reduced dosage.
“We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” Soriot told the Sunday Times.
Phase 3 trials of a Sinopharm coronavirus vaccine found it was 79 percent effective, the Chinese pharma giant said Wednesday, lower than rival jabs developed by Pfizer-BioNTech and Moderna but a potential breakthrough in the battle to stem the pandemic in Asia.
China has been racing against the West to develop its own Covid-19 vaccines, with five already in large-scale Phase 3 clinical trials.
But Wednesday’s announced was the first data released regarding the efficacy of a Chinese vaccine candidate.
“The protective effect of the (Sinopharm CNBG Beijing) vaccine against Covid-19 is 79.34 percent,” said the Beijing Institute of Biological Products, a Sinopharm subsidiary.
Sinopharm has applied to China’s drug regulator for approval of the inactivated coronavirus vaccine, the statement said, a type of inoculation using particles of the pathogen.
But China has struggled to gain international trust for its vaccine candidates, hindered by a lack of transparency on test results.
It has also been slow to complete Phase 3 trials, which had to be conducted abroad due to China’s success at curbing the spread of Covid-19 within its own borders.
Chinese officials have repeatedly assured the public of the vaccines’ safety, claiming that there have been no serious adverse reactions.
More than one million people have already been vaccinated with unapproved vaccines in China under its emergency use programme, including frontline health workers, state-owned enterprise employees and workers planning to travel abroad.
The United Arab Emirates approved a Sinopharm vaccine earlier this month, becoming the first foreign country to approve a China-developed Covid-19 vaccine. It said the vaccine was 86 percent effective, according to interim results of a Phase 3 trial.
Beijing has pledged to share the vaccine at a fair cost — a potential boost for poorer Asian countries who are otherwise reliant on limited distribution offered by the COVAX scheme.
“China has made the firm commitment that after China’s new coronavirus vaccines are completed and put into use, they will serve as a global public product and be supplied to the world at a fair and reasonable price,” foreign ministry spokesman Zhao Lijian said Friday.
“We will also give priority to developing countries for vaccines. This will be made through a variety of ways, including through donations and aid.”
Jordan has ordered one million doses of the novel coronavirus vaccine, with the first shipment expected at the end of January or early February, the health minister said Monday.
Jordan has recorded 289,748 cases of the Covid-19 disease, including 3,778 deaths, and the numbers continue to rise daily.
“Jordan will receive one million vaccines from Pfizer-BionNTech in instalments from January or early February,” said Health Minister Nazir Obeidat in remarks carried by the state-run Petra news agency.
He said the country was seeking to make vaccines available to more than 20 percent of the 11 million-strong population, “which means to suffice for 2.2 million citizens”.
Jordan announced in mid-December that it had approved emergency use of the Pfizer-BioNTech coronavirus vaccine, adding that talks were underway with other pharmaceutical firms.
Last week, Jordan launched a website for those wishing to be vaccinated to register to obtain the jab, on condition that they be front line health workers, over 60 or suffering from chronic health conditions.
The announcement comes days after authorities arrested journalist Jamal Haddad over an online article alleging the coronavirus vaccine had already arrived in the Middle Eastern country and that officials had received the jab.
Haddad was accused of “endangering public security and causing sedition and public disorder”, a judicial source told AFP on Saturday.
He was to be detained 15 days while awaiting trial over the article titled “What about the people? Did Pfizer arriver in secret, and have senior officials in the Jordanian government been vaccinated”.
The EU’s medicines watchdog said on Thursday that it had brought forward the date for a decision on authorising Moderna’s coronavirus vaccine by nearly a week to January 6.
The Amsterdam-based European Medicines Agency has been under growing pressure to speed up, and earlier this week accelerated the timeframe for Pfizer/BioNTech’s jab.
The EMA had originally been due to decide on US-based Moderna’s vaccine on January 12, but said the company had submitted extra data on Thursday “ahead of schedule”.
“Taking due account of the progress made, the Committee has scheduled an extraordinary meeting on 6 January 2021 to conclude its assessment, if possible,” the EMA said, referring to the medicines committee that decides on such issues.
“The meeting planned for 12 January 2021 will be maintained if needed.”
A clinical trial of 30,400 people found the Moderna vaccine was 94.1 percent effective in preventing Covid-19 compared to a placebo, performing slightly better in younger adults compared to the elderly.
EMA chief Emer Cooke said the under-fire agency had shown it was able to respond.
“We have been able to revise the timetables for the evaluation of the Covid-19 vaccines due to the incredible efforts of everybody involved in these assessments,” Cooke said in a statement.
“The number of infections is increasing across Europe and we are aware of the huge responsibility we have to get a vaccine to the market as quickly as is feasible, whilst maintaining the robustness of our scientific review.”
With Britain and the United States having pushed through emergency authorisation of the Pfizer/BioNTech vaccine, the EMA has been under pressure to speed up, notably from Germany.
The watchdog, which moved from London last year after Brexit, will decide on a year-long “conditional marketing authorisation” for Pfizer/BioNTech on Monday, having brought the date forward from December 29.
The United States kicked off a mass vaccination drive Monday hoping to turn the tide on the world’s biggest coronavirus outbreak, as the country’s death toll neared a staggering 300,000.
A nurse in New York became the first person in the US to be vaccinated when she received the Pfizer-BioNTech shot live on television.
“I feel great. I feel relieved,” said Sandra Lindsay, a critical care nurse at the Long Island Jewish Medical Center, imploring all Americans to “to do our part” by getting vaccinated.
“I hope this marks the beginning of the end of the very painful time in our history,” she added.
The landmark moment comes at one of the darkest phases of the pandemic, with infections in the United States and many other countries soaring, and health experts still struggling against vaccine skepticism, lockdown fatigue and uneven adherence to safety rules.
The US has the world’s highest death toll of more than 299,000, and the largest number of reported cases, at 16.2 million — including more than 1.5 million new infection in just the past week.
“First Vaccine Administered. Congratulations USA! Congratulations WORLD!” tweeted President Donald Trump.
Delivery trucks with special refrigeration equipment were rolling out across America, as part of a public-private plan to ship millions of doses of the newly approved Pfizer-BioNtech vaccine to vulnerable Americans.
Courier services FedEx and UPS have deployed fleets of trucks and planes to carry their precious cargo — sometimes under armed guard — to all 50 states, where health care workers and nursing-home residents will be first in line.
An initial 2.9 million doses are set to be delivered by Wednesday, with officials saying 20 million Americans could receive the two-shot regimen by year end, and 100 million by March.
UPS and FedEx were to ship glass vials of the vaccine to 636 sites around the country by Wednesday.
Doses are being shipped in boxes containing dry ice that can keep supplies at -70 degrees Celsius (-94 degrees Fahrenheit), the frigid temperature needed to preserve the drug.
– German lockdown –
Trials have shown the vaccine to be 95 percent effective, and Americans were being told it was safe unless they have an allergy to any of the drug’s components.
Experts face a battle to convince enough Americas to take the vaccine to make it effective though, in a country where the anti-vaccine movement is strong.
“My biggest concern is the level of hesitancy in the country. I really hope we are going to be able to change that,” Moncef Slaoui, head of the government’s vaccine rollout program Operation Warp Speed, told CBS.
Worldwide, there have been at least 1.6 million deaths since the outbreak emerged in China last December, and 71.6 million cases overall.
Canada also began distributing the Pfizer-BioNTech vaccine on Monday after the first shipment of doses arrived in the country on Sunday night.
The start of the campaigns in North America this week come as Germany prepares to enter a partial lockdown from Wednesday, with non-essential shops and schools to close in a bid to halt an “exponential growth” in infections.
Elsewhere, Italy has overtaken Britain as the European nation with the highest death toll at 64,520.
Even as US officials welcomed the unprecedented vaccine effort, they cautioned people not to grow lax in observing precautions.
“It’s going to take months before the vaccine hits critical mass. So, this is the light at the end of the tunnel, but it’s a long tunnel,” said Governor Andrew Cuomo of New York state, where 35,000 people have succumbed to Covid-19.
The US green-lighted the Pfizer-BioNTech COVID-19 vaccine late Friday, paving the way for millions of vulnerable people to receive their shots in the world’s hardest-hit country.
President Donald Trump immediately released a video on Twitter, where he hailed the news as a “medical miracle” and said the first immunizations would take place “in less than 24 hours.”
It comes as infections across America soar as never before, with the grim milestone of 300,000 confirmed deaths fast approaching.
The US is now the sixth country to approve the two-dose regimen, after Britain, Bahrain, Canada, Saudi Arabia and Mexico.
The move came earlier than expected, and capped a day of drama after it was widely reported that the White House had threatened to fire Food and Drug Administration chief Stephen Hahn if he did not grant emergency approval Friday.
Trump’s intervention reinserts politics into the scientific process, which some experts have said could undermine vaccine confidence.
The US is seeking to inoculate 20 million people this month alone, with long-term care facility residents and health care workers at the front of the line.
The government also said Friday that it is buying 100 million more doses of the Moderna vaccine candidate, amid reports the government passed on the opportunity to secure more supply of the Pfizer jab.
The purchase brings its total supply of Moderna doses to 200 million, enough to immunize 100 million people with the two-shot regimen that could be approved as early as next week.
Both frontrunners are based on mRNA (messenger ribonucleic acid), a major victory for a technology that had never previously been proven.
Two other vaccine candidates stumbled Friday: France’s Sanofi and Britain’s GSK said their vaccine would not be ready until the end of 2021.
And in Australia, the development of a vaccine at The University of Queensland was abandoned Friday after clinical trials produced a false positive HIV result among subjects involved in early testing.
– Sputnik mix – The mixed news on the vaccine front comes as infections accelerated fast in North America and parts of Africa but started to stabilize in Europe and drop in Asia and the Middle East.
Around the world more than 1.58 million lives have been lost to Covid-19 since it emerged in China a year ago, according to an AFP tally from official sources.
Brazil on Friday crossed 180,000 deaths, despite President Jair Bolsonaro’s insistence the crisis was at the “tail end.”
But across the Pacific Ocean, New Zealand, which has been praised for its handling of the virus, took its first tentative steps towards reopening its borders — with the tiny Cook Islands.
Countries which have approved the Pfizer-BioNTech jab meanwhile were preparing for roll out, as the World Health Organization warned of a potentially grim Christmas season.
Following Britain’s lead, the first vaccine shipments to 14 sites across Canada are scheduled to arrive Monday with people receiving shots a day or two later.
Israel, which accepted its first shipment of the Pfizer vaccine on Wednesday, is targeting a rollout on December 27.
And Hong Kong said Friday it had struck deals for two vaccines — one from Pfizer and the other from Beijing-based Sinovac — with plans to launch a campaign in early 2021.
A new combined approach is also being tested by AstraZeneca, whose Russian operation said it would mix its shot with the locally-made Sputnik V vaccine in clinical trials.
Russia and China have already begun inoculation efforts with domestically produced vaccines that have seen less rigorous vetting.
EU countries are eagerly awaiting clearance on the Pfizer and Moderna vaccines, in late December and early January respectively.
– Carbon down – As Europe’s surge eases off slightly, France is planning to lift a six-week-long lockdown from Tuesday but impose a curfew from 8.00 pm, including on New Year’s Eve.
Greece also announced new plans Friday to slash quarantine time for incoming travelers and reopen churches for Christmas.
But Switzerland, which is seeing a sharp resurgence in cases, announced a 7:00 pm curfew for shops, restaurants and bars.
While lockdowns have brought economic pain, boredom and myriad other woes, the effect on the environment has been more positive.
Carbon emissions fell a record seven percent in 2020 as countries imposed lockdowns, according to the Global Carbon Project.
An expert committee convened by the US Food and Drug Administration voted heavily in favor of recommending the Pfizer-BioNTech Covid-19 vaccine for emergency use approval on Thursday.
The final voting tally was 17 in favor, four against and one abstention.
The committee was tasked with answering whether, “based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risk for use in individuals 16 years of age and older?”
The vote by the independent experts and researchers, including infectious disease specialists, biostatisticians and other scientists, isn’t binding but the FDA is expected to follow the recommendation within the coming days.
Britain, Canada, Bahrain and Saudi Arabia have already approved the vaccine, the first in the world to complete a large-scale, phase 3 clinical trial.
Russian and Chinese vaccines are already being administered on a large scale, but without having completed comparable clinical trials.
The full results of the trial, which included nearly 44,000 people, were published Thursday in the New England Journal of Medicine, another major milestone.
These confirmed the vaccine was 95 percent effective with no serious safety issues, an outcome that was described in an accompanying editorial as a “triumph.”
Pfizer scientist Kathrin Jansen told the panel this was a result of the innovative messenger RNA technology behind the vaccine, an approach that has never before been approved.
Britain on Wednesday reported that two health care workers developed significant allergic reactions to the vaccine as the country rolled out its massive drive Tuesday.
The FDA will therefore include a warning label on the vaccine if it’s approved, the agency’s Marion Gruber said.