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FDA Says Pfizer-BioNTech Covid-19 Vaccine Safe And Effective For Children Under 5

Staff for the US Food and Drug Administration (FDA), said on Sunday that the Covid-19 vaccine made by Pfizer and BioNTech is safe and effective for children under the age of 5. Staff members said the vaccine is effective in producing a virus-blocking response without any major safety concerns, now the results will be studied by a group of independent advisers for the FDA.

Independent experts working for the agency will review a request for emergency use authorization for the vaccine in children under the age of 5. The group will also review a similar request from Moderna for the use of their vaccine for children under the age of 6. 

After the advisers make their recommendations, the FDA will then decide whether or not to follow the panel’s advice, which it likely will. If the agency approves, and the Centers for Disease Control and Prevention (CDC) do the same, the vaccines could be available for young children and infants as soon as the beginning of next week. 

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According to the FDA, “overall preliminary data indicated the vaccine was 80.4% effective in preventing symptomatic covid-19. The rate was 75.6% for babies and toddlers six to 23 months old, and 82.4% for children 2-to-4-years-old.

It’s still too soon, however, to reach definitive conclusions on the vaccine’s effectiveness.”

“Side effects were minimal and included irritability and drowsiness for children 6-to-23-months-old, and pain at the injection site and fatigue for children 2 to 4. Babies and children younger than 5 — a group numbering 19 million — remain the only age group in the United States not yet eligible for a coronavirus vaccine.”

The FDA also emphasized with these findings that they believe vaccines for the youngest group of Americans are critical for navigating the rest of the pandemic. 

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“Given the uncertainty of the pandemic and likely continued virus transmission in coming months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19 associated morbidity and mortality in this age group,” the agency said.

Assuming that both Pfizer and Moderna receive an emergency use authorization, most children will likely be able to receive their shots at their pediatricians office, however, many states and communities are already gearing up to set up vaccine clinics and make the shots available throughout local pharmacies. 

Sallie Permar, an expert in pediatric vaccines, said that her facility will offer both vaccine options to ideally make it easier for the parents to choose what they want their child to receive. 

“While there may be some confusion over the difference between the two vaccines, offering both gives you more flexibility. Parents can weigh all the information and decide,” she explained. 

Getting Vaccine

US On Track To Begin Vaccinating Kids Aged 5 To 11 By November 

According to Dr. Anthony Fauci the US is currently on track to start vaccinating children aged 5 to 11 by early to mid-November. An advisory committee with the FDA is meeting today to vote on the use of the Pfizer-BioNTech vaccine for the younger age group. 

Last week, a review panel for the FDA found that the benefits of the shots in young kids outweigh the risks. Currently the Pfizer-BioNTech vaccine is approved for all US teens 12 and older. 

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The FDA announced on Friday that the vaccine showed a general efficacy rate of 90.7% against symptomatic infection in nearly 2,300 elementary-school-age children seven days after they got the shot. The most common side effects appeared after the second dose which included pain at the injection site, fatigue, and headache. No serious events have been reported in young children from the vaccine. 

Covid in general isn’t as much of a risk for children as it is for older individuals, however, more than 630 individuals under the age of 18 have died due to the virus in the US, according to the CDC. Additionally, nearly 6.2 million children have been infected with the coronavirus and more than 1.1 million of those were caused by the Delta variant. 

Moderna said early Monday that a “Phase 2/3 clinical study of its COVID vaccine in 5- to 11-year-olds generated a robust neutralizing antibody response.” The company also said it plans to submit the clinical data to the FDA in the “near term.” 

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According to a New York Times tracker, the US is continuing to average more than 1,500 Covid-related deaths a day, however, hospitalization rates are declining. The US is averaging about 75,000 new cases a day, which is less than half what it was in early September, according to the tracker. 

Most cases and deaths are occurring among the unvaccinated, causing experts to continue to urge skeptical groups to get their inoculations and avoid dying a preventable death. Alaska, Montana, Wyoming, Idaho, Vermont, New Hampshire, and Colorado are all hotspots in the US right now. 

According to the CDC, about 190.6 million people in the US are fully vaccinated, which is equivalent to about 57.4% of the population. Experts are still adamant that the nation needs to pass the 70% mark in order to truly stop the spread of this virus. Vaccine mandates have begun being enforced throughout many different sectors of business, and the government.

Doctor with Covid-19 Vaccine

BioNTech Co-Founder Says ‘Covid Will Become More Manageable’ In The Coming Months 

Co-founder and chief medical officer of BioNTech, the German firm which developed a Covid-19 vaccine with Pfizer, Dr. Ozlem Tureci, told the media recently that the “world should not live in fear of the Covid-19 virus.”

“Covid will become more manageable. It already has started to become manageable, however, we will need to go back to a new normality, because this virus will accompany us for, still, some years.” 

Dr. Tureci explained that when it comes to new coronavirus variants, “BioNTech will continuously assess them as they appear, and there will be more. For all these variants which are currently circulating, it seems that boosters alone, bringing the waning immune responses back to high levels, are suitable and do protect.” 

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“However, we have to continue to screen because there might be variants upcoming for which this is not the case. And for this we have a second pillar, namely that we prepare ourselves to be quick and fast in the case that we need to adapt to a variant … And we are doing those dry runs, not alone, together with regulators, so that they are also prepared for the potential need to switch,” Tureci explained. 

Tureci co-founded BioNTech in 2008 with her husband, Chief Executive Ugar Sahin. She explained how more data is needed to guide us through the rest of the pandemic, but she can picture a future where boosters are given out every 12 to 18 months. 

BioNTech’s overall focus as a company is to “pioneer individualized immunotherapies for cancer medicine and using mRNA technology,” which is used to stimulate the body’s own immune response.

“So we had, already, the science and the knowledge about immune mechanisms and how they can be used against viruses and could leverage that. And the other pillar of our response was our technology, the mRNA technology, which allows [it] to be used as a vaccine format, which means it allows [it] to communicate with the immune system and teach it how to respond against this new enemy with high precision,” she explained. 

“And this technology, because we had used it in clinical trials in cancer patients, was already ripe. We knew how to conduct clinical trials with it, how to treat humans with it, and how to set up a manufacturing process,” she added.

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This extensive experience is what led the company to developing the mRNA Covid-19 vaccine within a year of the pandemic. When it comes to future vaccines for other diseases and viruses that impact the immune system, Tureci explained that there has been “high prioritization which was required for this global threat, but there were definitely lessons which could be learned and taken forward with future vaccines.” 

“There are a couple of things which, I think, if we transfer them into future drug developments can help us to be quicker. Also, for example, for non-pandemic infections, but also for cancer and autoimmune disease.”

Other vaccines currently circulating throughout the world, such as the Oxford-AstraZeneca vaccine, are also being led by female scientists, which Tureci believes is “very important.” These high-profile examples of gender balance in science create an overall new standard for equality and representation in STEM fields that have been previously dominated by men. 

“I actually truly believe that one of the secrets why we have been successful as a team and as a company is that we are a gender-balanced team. Almost half of our workforce is female and also on the top management level, half of our teams are female,” she explained.

“However, what I also realize is that in our teams we don’t recruit women because we want to fulfil any gender quota, it comes naturally … And it simply turns out that half of them are women,” she said.

US To Donate 500 Million Additional Covid-19 Vaccines To Lower Income Nations 

Pfizer and BioNTech will be providing the United States with an additional 500 million doses of their Covid-19 vaccine, specifically to be donated to low and lower-middle income countries who have been struggling with their vaccine distribution rates due to wealthier countries gaining priority access. 

The company’s existing agreement with the US government is now being expanded so that the US government provides even more vaccine doses at a not-for-profit price for less-advantaged nations. With this recent move to increase dose donation, the total number of doses to be supplied for donation should be around a billion. 

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The initial agreement still stands, which states the US government will allocate doses of the Pfizer-BioNTech Covid-19 vaccine to 92 lower income countries, and the 55 member states of the African Union. 

Pfizer released a press release Wednesday which states deliveries of the initial 500 million doses began back in August, and the total 1 billion doses under the new expanded agreement will begin to be delivered by the end of September 2022. 

The first doses allocated through this specific program arrived in Rwanda in mid-August and since that point more than 30 million doses have been shipped to 22 countries. 

Pfizer and BioNTech also have an existing agreement to provide vaccine doses to the COVAX Facility, a mechanism set up by Gavi, The Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization. The overall goal of all of these programs is to provide vaccines and additional pandemic support to lesser developed nations. 

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Developed nations like the US and those in Europe have had an excessive supply of Covid vaccines since the number of eligible individuals for the vaccine quickly reached all individuals 12 and up. General populations were able to receive their inoculations through mass vaccination campaigns rather quickly when compared to lower-income nations who lacked the supply in the first place. 

A majority of adults in the US and Europe are now fully vaccinated, however, millions of individuals around the world don’t even have access to the vaccine, leaving the entire world still at risk with this pandemic; as exemplified by the development of multiple variants due to a lack of consistency with vaccination rates around the world. 

According to the CDC, “in the US, 64.1% of the population above the age of 12 is fully vaccinated.” In the UK, “81.9% of people over 16 are fully vaccinated,” according to British government data. According to the European Center for Disease Prevention and Control, throughout the entire European Union 71.7% of adults are fully vaccinated. 

43.5% of the world’s population has received at least one dose of a Covid-19 vaccine, but only 2% of people in lower-income nations have received at least one dose. Overall, it’s up to the wealthier nations throughout the world to help the rest of the planet become immune from this virus so that we have a real chance at returning to a life of normalcy.  

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FDA Permits Use Of Pfizer-BioNTech Covid-19 Vaccine For Kids 12 And Up 

The Food and Drug Administration announced this week that they approved the use of the Pfizer and BioNTech Covid-19 vaccine for kids aged 12 and up; previously the vaccine was only approved for individuals 16 and older. 

The administration’s approval will ideally get all middle and high school students vaccinated before the fall semester. The FDA is also hoping that the approval will accelerate America’s effort to drive down new infections and reach herd immunity. 

The Centers for Disease Control and Prevention’s vaccine advisory committee is scheduled to meet this Wednesday to review the shot completely for use in kids. If approved by the CDC, as it is expected too, adolescents can begin receiving their shots as early as this week. 

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Acting FDA Commissioner Dr. Janet Woodcock said “the decision brings us closer to returning to a sense of normalcy and to ending the pandemic. I want to assure parents that the agency undertook a rigorous and thorough review of all available data before clearing it for use in the teens.”

The companies expressed how in late March the vaccine was found to be 100% effective in a clinical trial of more than 2,000 adolescents, as well as activated a “robust” antibody response in younger children. All apparent side effects were also consistent with those seen in adults. 

Health experts have long claimed that vaccinating children is an essential step to ending the pandemic, and is the only way America has a shot at reaching herd immunity. According to government data children make up 20% of the total U.S. population. “Between 70% and 85% of the U.S. population needs to be vaccinated against Covid to achieve herd immunity, and some adults may refuse to get the shots. Though more experts now say herd immunity is looking increasingly unlikely as variants spread,” experts claim.

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The White House’s chief medical adviser, Dr. Anthony Fauci, said in April that “the US could begin vaccinating older kids against Covid-19 by the fall while elementary-age children may start getting their shots by early next year.” 

Approval by the FDA for kids under the age of 12 could potentially come in the second half of the year, according to Fauci. Pfizer claims that it expects to apply for authorization for its vaccine to be given to toddlers and younger children in September, and infants in November. Pfizer has also become the first vaccine manufacturer to begin the submission process to get full FDA approval for its use of the vaccine in people 16 and older. 

Pfizer and BioNTech reported that they began a clinical trial for their vaccine in healthy 6-month to 11-year-old children. 

This will also be a major step in President Biden’s efforts to bring back full in-person learning for America’s kids in the fall. The administration even announced plans to invest $10 billion into Covid-19 testing for schools specifically.

Coronavirus Vaccine in Bottles

Pfizer-BioNTech Vaccine Proven To Reduce Symptomatic Covid-19 In Real World

Researchers in Israel this week announced that Pfizer-BioNTech’s Covid-19 vaccine has appeared to reduce symptomatic coronavirus infections by more than 90% in the real world now that more and more populations are receiving their doses. 

The preliminary findings suggest that the vaccine itself has remained as successful as researchers initially proved in their vaccine trials. Within a clinical vaccine trial the conditions are greatly controlled to monitor the actual effectiveness of the shot, however, that monitoring already eliminates a slew of other risks that exist within the real world that could impact the vaccine’s efficacy. 

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Luckily, nothing of the sort has occurred, and the vaccine is still wildly successful. The Clalit Research Institute is a major part of Israel’s healthcare system, and they’re the ones who analyzed data on 1.2 million individuals; half of which received the Pfizer-BioNTech vaccine. The researchers wanted to compare patients who had received the vaccine and individuals with similar immune systems who hadn’t.

The researchers wanted to analyze the rate in which symptomatic Covid-19 was spreading with the release of this vaccine; meaning they looked at individuals who contracted the virus and actually felt sick. Symptomatic Covid-19 was proven to decrease by 94% among individuals who have received their two doses of the vaccine, according to a press release from Clalit. The rate of serious illness caused by the virus decreased by 92%. 

The research has yet to be published by the Institute because they’re still waiting for it to be peer-reviewed so that the results are as accurate as possible. However, the results are already consistent with the data that Pfizer initially released to prove their vaccine would be effective. 

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Pfizer’s initial data from their vaccine trial showed that their Covid-19 vaccine was 95% effective against symptomatic coronavirus. In the trial itself, participants were either given the actual vaccine or a placebo. They then observed how many people from each group got infected after the fact. 

Pfizer’s clinical study was considered to be the “golden standard in clinical research” according to the Institute due to the fact that it was a randomized and controlled trial. The studies from Israel are now observational, meaning researchers aren’t randomly picking individuals who got the vaccine or not already.

Observational studies can skew the data in this case, however, due to the fact that different individuals who choose to be vaccinated are likely going to take less or more steps towards protecting themselves from potential infection. 

While the observational aspect of this study may not be as effective as a controlled trial, the combination of these new results with the results that came from Pfizer and BioNTech themselves shows the world that the vaccine is just as effective as anticipated, and we should all continue to do our parts to protect each other and bring this pandemic to an end.

Covid-19 Variants Causing Scientists To Rethink Vaccine Strategy

Top vaccine scientists throughout the world have made it known that current Covid-19 vaccine rollout programs need to be reexamined after variants of the virus are proving to be more resistant.

African Union Secures An Additional 270 Million Covid-19 Vaccines 

The African Union has now secured an additional 270 million Covid-19 vaccines to be distributed among the many countries within the continent. The African Vaccine Acquisition Task Team (AVATT), however, is still not convinced that this will be enough to meet the entire nation’s demand. 

From April to June at least 50 million doses of the Pfizer/BioNTech and AstraZeneca vaccines will be available according to the AVATT press release published this week. Chair President of the African Union Cyril Ramaphosa recently spoke with the media about the increase in doses that Africa is now set to receive. 

“From the onset of this pandemic our focus as a continent has been on collaboration and collective effort. We have held steadfastly to the principle that no country should be left behind.”

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Ramaphosa also emphasized that “all 270 million vaccine doses will be made available this year with at least 50 million being available for the crucial period of April to June 2021.” The African Union secured these doses along with a vaccine program from COVAX; a World Health Organization and Gavi Vaccine Alliance initiative that specifically works to bring more vaccines to Africa.

The WHO Regional Director for Africa, Dr. Matshidiso Moeti, recently spoke with the media to praise Africa for the acquisition of the additional doses and adoption of the program from COVAX, as it shows true initiative and will make a real difference in getting the continent vaccinated as promptly as possible. 

“Covax can only cover 20% of the African population, so it’s wonderful to see the African Union’s efforts to secure a provisional 270 million doses by the end of 2021.”

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President Ramaphosa did caution, however, that while this new initiative is vital for Africa’s recovery, it “may not extend beyond the needs of frontline health care workers, and may this not be enough to contain the ever-increasing toll of the pandemic in Africa.” 

Africa is currently experiencing a second wave of Covid-19 that is currently higher than the peak they hit back in July 2020. The continent currently has an average daily new case count of more than 25,000 for the past 14 days. 

The African Export-Import Bank will be implementing a strategy this month that will provide up to $2 billion in advancements to vaccine manufacturers in the continent. The African Union and World Bank will also be working together to grant member states access to a $5 billion fund specifically for purchasing more vaccines when needed. 

The announcement of these plans couldn’t have come at a more crucial time for Africa, as Ramaphosa reported this week that South Africa is extending their Covid-19 restrictions due to a “massive increase” in Covid-19 cases driven by a new strain of the virus that is thought to be much more transmissible.

US Prepares To Approve A Second Covid-19 Vaccine As Cases Rise Exponentially

This Tuesday a multitude of healthcare workers and assisted living facility residents received their first dose of the Pfizer and BioNTech Covid-19 vaccine. It’s expected that about 20 million people will receive their first shots by the end of December.

UK First Covid-19 Vaccine

First Individuals Receive Covid-19 Vaccine In UK 

The United Kingdom has become the first nation in the world to begin administering a Covid-19 vaccine to its citizens in a non-trial context. 90-year-old Margaret Keenan received the first of two doses of the Pfizer/BioNTech vaccine this morning. Keenan turns 91 next week, and claims to feel “privileged” that she was given the first shot. 

“It’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year.”

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William Shakespere is the 81-year-old Briton who received the second shot of the Covid-19 vaccine after Keenan this morning. Throughout the rest of the UK, Nurse Joanna Sloan became the first person in Northern Ireland to receive the vaccine and George Dyer became the first individual living in London to get the shot. 

Dyer is a former butcher and hospital volunteer who claims to feel very lucky to be one of the first people in the world to receive the vaccination. “Covid-19 is a terrible thing and I feel very lucky that I can now get this vaccine to keep the virus away. It’s like I’m about to be given a new lease of life, and I cannot wait to get back out there and make myself useful again.”

Gill Rogers is a Sussex resident who received the vaccine on Tuesday. Rogers’ husband unfortunately died from the virus back in April, and she claims the grief has been “quite hard” to endure especially in isolation, so the vaccination is giving her the ability to at least go outside and see others with a little less worry. 

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All vaccinated individuals should continue to abide by all standard health and safety practices implemented by the CDC until further notice, however, the vaccine does at least provide that extra layer of security. UK Prime Minister Boris Johnson told the UK media this Tuesday morning that the vaccine will “gradually make a huge difference. It’s amazing to see the vaccine come out, it’s amazing to see this tremendous shot in the arm for the entire nation, but we can’t afford to relax now. I would just say to all those who are scared, don’t be … you see people take the vaccine this morning, in large numbers, people are going to be taking it in the next few days, and weeks and there is nothing to be nervous about.”

The UK has ordered 40 million doses of the Pfizer vaccine but only 800,000 shots will be made available for the first wave of distribution so that other parts of the world that have already reserved dosages of the vaccine will have access to them as well once their respective governments give them the go ahead. 

The vaccine also is two doses administered at least three weeks apart, so around a third of the UK will be vaccinated after the first round of distribution. If the Moderna Covid-19 vaccine gets approved as well in the coming weeks, as it’s currently projected to, the UK will also have 7 million doses reserved for itself. 

Currently there are 50 vaccination hubs in hospitals across England and dozens others across Wales and Scotland. Individuals over the age of 80 as well as healthcare workers will be the first to be vaccinated. For now it’s only being made available via invitation for those 80 or over/all workers in the healthcare industry.