Keypoints
- Pharmaceutical company Pfizer and biotechnology company BioNTech have requested to have their coronavirus vaccine licensed for children ages 5 to 11 across the European Union.
- Pfizer and BioNTech submitted data of study testing to the European Medicines Agency.
- There are currently no COVID-19 vaccines licensed for use in children younger than 12 in Europe or North America.
- If EU regulators agree, it would be the first opportunity for younger children in Europe to get immunized against COVID-19.
- Pfizer also asked the U.S. government Thursday to allow the use of its COVID-19 vaccine in children ages 5 to 11 on October 7, 2021.
- The results showed a “strong immune response” in the children and that the vaccine was also found to be safe.
- The vaccine was the first COVID‑19 vaccine to be authorized by a stringent regulatory authority for emergency use
The first opportunity for younger children in Europe to get immunized against COVID-19.
Pharmaceutical company Pfizer and biotechnology company BioNTech said Friday they have requested to have their coronavirus vaccine licensed for children ages 5 to 11 across the European Union.
If EU regulators agree, it would be the first opportunity for younger children in Europe to get immunized against COVID-19.
Pfizer and BioNTech said they submitted data to the European Medicines Agency, including late-stage results from a study testing their COVID-19 vaccine in more than 2,200 children ages 6 months to 11 years. The children received a lower dose than what’s normally given to adults.
The companies said in a statement that the results showed a “strong immune response” in the children and that the vaccine was also found to be safe. There are currently no COVID-19 vaccines licensed for use in children younger than 12 in Europe or North America; the ones made by Pfizer-BioNTech and Moderna are authorized for children 12 and older in the European Union
Earlier this month, Pfizer and BioNTech asked the U.S. Food and Drug Administration to greenlight their vaccine for children ages 5 to 11.
Expanding vaccine availability to roughly 28 million more U.S. children was seen as another milestone in the fight against the virus and comes amid an alarming rise in serious infections in youngsters because of the extra-contagious delta variant.
In the United States, COVID-19 has killed at least 520 children so far, according to the American Academy of Paediatrics.
With much of Europe’s adult population already immunized, many countries are seeing increasing outbreaks of the disease in children while schools are mostly open and operating with sometimes patchy guidance on mask-wearing and social distancing.
The World Health Organization has said that vaccinating children was not a priority because they are far less likely to develop serious diseases or to die of COVID-19. The health agency has repeatedly urged rich countries to share their doses with poor countries instead of expanding domestic eligibility so the world’s vulnerable populations can be immunized.
What is the Pfizer-BioNTech Covid-19 vaccine?
The Pfizer–BioNTech COVID-19 vaccine (INN: tozinameran), sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech and for its development collaborated with American company Pfizer, for support with clinical trials, logistics, and manufacturing. It is authorized for use in people aged twelve years and older in some jurisdictions and for people sixteen years and older in other jurisdictions, to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial advice indicated that vaccination required two doses given 21 days apart, but the interval was later extended to up to 42 days in the US, and up to four months in Canada.
The vaccine was the first COVID‑19 vaccine to be authorized by a stringent regulatory authority for emergency useand the first cleared for regular use. In December 2020, the United Kingdom was the first country to authorize its use on an emergency basis. It is authorized for use at some level in the majority of countries. On 23 August 2021, the Pfizer–BioNTech vaccine became the first COVID-19 vaccine to be approved in the United States by the Food and Drug Administration (FDA) for those aged sixteen years and older.
As of September 2021, more than 1.5 billion COVID-19 vaccine doses have been shipped by the company worldwide. As of 30 March 2021, Pfizer and BioNTech aimed to manufacture about 2.5 billion doses in 2021. Distribution and storage is a logistical challenge because the vaccine needs to be stored at extremely low temperatures. BioNTech and Pfizer are testing a freeze-dried version that would not need ultracold storage.
Effectiveness of Pfizer vaccine.
A case-control study published in May 2021, in The New England Journal of Medicine found that, among vaccine recipients in Qatar, the Pfizer-BioNTech vaccine has an effectiveness of 89.5% against any documented cases of the Alpha variant (lineage B.1.1.7) and 75% effectiveness against the Beta variant (lineage B.1.351). The same study reported that the effectiveness of the vaccine against severe, critical, or fatal disease against any variant of SARS-CoV-2 is 97.4%.
A test-negative[note 1] case-control study published in August 2021 found that two doses of the BNT162b2 (Pfizer) vaccine had 93.7% effectiveness against symptomatic disease caused by the alpha (B.1.1.7) variant and 88.0% effectiveness against symptomatic disease caused by the delta (B.1.617.2) variant. Notably, effectiveness after one dose of the Pfizer vaccine was 48.7% against alpha and 30.7% against delta, similar to effectiveness provided by one dose of the ChAdOx1 nCoV-19 vaccine.
On 27 August, the Centers for Disease Control and Prevention published a study reporting that the effectiveness against infection decreased from 91% (81–96%) to 66% (26–84%) when the Delta variant became predominant in the US, which may be due to unmeasured and residual confounding related to a decline in vaccine effectiveness over time.
The effectiveness of the vaccine starts to decline around six months.
Unless indicated otherwise, the following effectiveness ratings are indicative of clinical effectiveness two weeks after the second dose. A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. Effectiveness is generally expected to slowly decrease over time.
Is it safe for children aged 5-11?
The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older.
But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.For elementary school-aged kids, Pfizer tested a much lower dose — a third of the amount that’s in each shot given now.
Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press. The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience, he said.
I think we really hit the sweet spot, said Gruber, who’s also a pediatrician. Gruber said the companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators.
Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data hopefully in a matter of weeks to decide if the shots are safe and effective enough for younger kids.
Many Western countries so far have vaccinated no younger than age 12, awaiting evidence of what’s the right dose and that it works safely in smaller tots. But Cuba one week prior began immunizing children as young as 2 with its homegrown vaccines and Chinese regulators have cleared two of its brands down to age 3.
While kids are at lower risk of severe illness or death than older people, more than 5 million children in the US have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen dramatically as the delta variant swept through the country.
I feel a great sense of urgency in making the vaccine available to children under 12, Gruber said.
There’s pent-up demand for parents to be able to have their children returned to a normal life. In New Jersey, 10-year-old Maya Huber asked why she couldn’t get vaccinated like her parents and both teen brothers have. Her mother, Dr. Nisha Gandhi, a critical care physician at Englewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. But the family hasn’t eased up on their masking and other virus precautions until they learn if Maya received the real vaccine or a dummy shot.
Once she knows she’s protected, Maya’s first goal: a huge sleepover with all my friends.
Maya said it was exciting to be part of the study even though she was super scared about getting jabbed. But after you get it, at least you feel like happy that you did it and relieved that it didn’t hurt,” she told the AP.Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged kids.
The FDA required what is called an immune bridging” study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults.That’s what Pfizer reported Monday in a press release, not a scientific publication. The study still is ongoing, and there haven’t yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo something that might offer additional evidence.
The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA’s Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer’s Gruber said once the vaccine is authorized for younger children, they’ll be carefully monitored for rare risks just like everyone else.
A second US vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year.
About Pfizer-
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German immigrants, Charles Pfizer and his cousin Charles F. Erhart
Pfizer develops and produces medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. The company has several blockbuster drugs or products that each generate more than US$1 billion in annual revenues. In 2020, 50% of the company’s revenues came from the United States, 8% came from each of China and Japan, and 36% came from other countries.
Pfizer was a component of the Dow Jones Industrial Average stock market index from 2004 to August 2020.The company ranks 64th on the Fortune 500and 49th on the Forbes Global 2000
About BioNTech-
(short form of Biopharmaceutical New Technologies) is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develops pharmaceutical candidates based on messenger ribonucleic acid (mRNA) for use as individualized cancer immunotherapies, as vaccines against infectious diseases and as protein replacement therapies for rare diseases, and also engineered cell therapy, novel antibodies and small molecule immunomodulators as treatment options for cancer.
The company has developed an mRNA-based human therapeutic for intravenous administration to bring individualized mRNA-based cancer immunotherapy to clinical trials and to establish its own manufacturing process
In 2020, BioNTech, partnering with Pfizer for testing and logistics, developed the RNA vaccine BNT162b2 for preventing COVID-19 infections, which offers a 95% efficacy in preventing confirmed COVID-19 occurring at least 7 days after the second dose of vaccine. On 2 December 2020, temporary HMR authorization was granted by the United Kingdom government for BNT162b2 vaccinations within the UK. It was the first mRNA vaccine ever authorized. Some days later the vaccine also got emergency approval in the United States, Canada, and Switzerland.
On 21 December 2020, the European Commission approved BioNTech/Pfizer’s coronavirus vaccine in accordance with the positive recommendation of the European Medicines Agency (EMA).
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