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Getting Vaccine

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

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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.

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Moderna Says Their Covid-19 Vaccine Is Safe For Adolescents 

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Moderna announced this Tuesday that their Covid-19 vaccine is safe and effective in adolescents. The company is basing the announcement after completing phase 2 of 3 of a trial of 3,732 children aged from 12 to 17 in the US. 

Blood tests showed that the vaccine produces an immune response that was equivalent to the findings in adults. 

The trial wasn’t designed to look at efficacy, but more so how safe it was for younger teens and adolescents to take it. Initial observations did show that none of the children who received the vaccine got sick with Covid-19 starting 14 days after their second dose. 

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“Four of the children who received the placebo tested positive for Covid-19, which is consistent with a vaccine efficacy of 100%, that figure could also change as more data is collected.”

The results also showed that the vaccine was 93% effective after one dose at preventing mild cases of Covid-19; meaning only one or two symptoms would appear in anyone who tests positive after being vaccinated. 

The company said “the vaccine was generally well tolerated and no significant safety concerns were identified. Side effects included headache, fatigue, muscle pain and chills after administration of the second dose. Pain at the injection site was also sometimes observed.”

Moderna is planning on submitting the results to the US Food and Drug Administration in early June along with a request for authorization to use the vaccine in adolescents. The data will also be submitted to a peer-reviewed publication, as every other vaccine has in America. 

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The Moderna vaccine was already authorized in the US for individuals 18 and older, and after Moderna requests an emergency use authorization from the FDA it’s likely that it will be approved for all Americans aged 12 and up. 

The FDA has already approved of the Pfizer vaccine to be given to adolescents aged between 12 and 15, previously it was only available for those 16 and older. The fact that both of these vaccines have already been used frequently in adults all across America, experts claim it makes sense that they’re both also effective in younger individuals. 

According to reports from CNN, “both Pfizer and Moderna are currently testing their vaccines in younger children, ages 6 months to 11 years. Because those age groups may require varying doses, the process will likely take a little longer.”

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases recently claimed that elementary aged children likely won’t be vaccinated until the end of the year, however, he’s confident that every American, regardless of age, will be eligible by 2022.

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

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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.

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United Kingdom Becomes First Country To Approve Covid-19 Vaccine For Public Distribution

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The UK has become the first Western nation to approve of a Covid-19 vaccine. This is a landmark moment for this global health crisis that will likely pave the way for the rest of the world and mark the beginning of the end of this pandemic.

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What You Need To Know About Pfizer’s Covid-19 Vaccine

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Pfizer and partner BioNTech made headlines this week after announcing that their Covid-19 vaccine was testing to be 90% effective; more than any other vaccine currently in a late-stage trial throughout the world. The news is still preliminary and a lot of questions are still unanswered, however, there is a decent amount of information that Pfizer and BioNTech has released in regards to their vaccine that could help ease some of those curiosities. 

In July, Pfizer and BioNTech began their late-stage clinical trial on their Covid vaccine. Like many of the trials currently occurring around the world, half the participants were given the vaccine, and the other half were given a saltwater placebo injection. Of the 44,000 individuals involved in the study only 94 have gotten sick with the coronavirus. When the board reviewed how many individuals got the vaccine versus the placebo, the results showed that the vaccine was over 90% effective. 

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The US Food and Drug Administration (FDA) said that a Covid-19 vaccine will only need to be 50% effective to be approved for emergency authorization. To make sense of the percentages, for reference, the flu vaccine fluctuates between 40% to 60% in efficiency every year. This means that it only fully protects between 40% – 60% of people who get the vaccine, however, it will likely minimize the intensity of the virus in everyone who receives it. These percentages fluctuate based on how bad the season is and how much the virus itself strengthens as time progresses. 

Pfizer and BioNTech haven’t reported any serious safety concerns as a result of their vaccine either, which is why the companies are so enthusiastic about the success of it. The chief executive of Pfizer said it could have 30-40 million doses of the vaccine before the end of 2020; that would be enough for 15-20 million people to get their initial shot and booster three weeks later.

Who will receive the initial doses is unclear, however, it’s been generally understood throughout the world that healthcare providers and other workers who are in more vulnerable positions will receive the initial rounds of the vaccine. The two companies predict they would be able to produce and distribute up to 1.3 billion doses a year, and while that may not be enough for the world’s entire population, other vaccines will likely appear during that time as well.

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Pfizer is applying for emergency authorization in the third week of November, after it submits at least two months of safety data to the FDA. Depending on how that authorization goes, higher risk populations could get vaccinated by the end of the year. 

One of the biggest open questions in regard to this vaccine is how it will impact individuals of different ages. The trial itself had participants that aged from 18 to over 65, however, as time went on they began including kids between the ages of 12 and 18 to make sure there weren’t any irregularities. So far, the companies have reported that the vaccine will likely protect everyone the same. 

In July, Pfizer received a $1.95 billion deal from the US government under Operation Warp Speed, the effort to rush a vaccine to the market, that entailed providing 100 million doses of the vaccine to US residents. While there has been some lack of clarity as to how well this deal has been able to hold, a spokesperson for Pfizer claimed on Monday that the company is a part of Operation Warp Speed. 

While this news from Pfizer and BioNTech is a huge sigh of relief, the world still has some ways to go, but we are on the right path. Continue to wear your mask and social distance every time you’re in a public setting and listen to your healthcare provider’s advice. As long as we keep abiding by the guidelines and waiting for the vaccine to be approved, this will all be over before we know it.

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Pew Survey Reveals Global Citizens’ Views on World Leaders

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In the United States, the president’s approval rating is historically low, hovering at about 42% while his disapproval rating rarely falls below 50%. However, the opinion of the United States president held by people around the world is even lower, as a recent Pew survey shows that almost two-thirds of people surveyed in 33 countries express “no confidence” in President Trump, whereas just 29% of those surveyed express confidence in him. The results vary widely by country, but only a handful of countries, including Israel, India, the Philippines, and Kenya, have a majority of citizens who approve of the president. Unsurprisingly given the president’s rhetoric about building a wall on the southern border of the United States, a whopping 89% of Mexicans surveyed expressed no confidence in the president, and the president has similarly high disapproval ratings across much of Europe, in particular Germany, Sweden, France, Spain, and the Netherlands. Interestingly, the percentage of global citizens Pew surveyed who approve of President Obama exactly matches the percentage of those surveyed who disapprove of President Trump at 64%.

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That being said, a majority of respondents surveyed worldwide, 54%, expressed favorable views of the U.S., whereas 38% had an unfavorable view. This suggests that people around the world separate their view of the president from their view of the country as a whole, perhaps reflecting a view that the presidency of Donald Trump is a fluke rather than a genuine reflection of the general attitudes of Americans. Trump ranked dead last among five of the world’s most influential leaders; by contrast, German chancellor Angela Merkel took first place, at a confidence level of 46%. Interestingly, none of the world leaders drew a global confidence level greater than 50%, suggesting that people around the world are skeptical of the world’s leadership as a whole.

Citizens of the world not only disapproved of President Trump as a leader, but also of many of the specific policies he has implemented or proposed. 68% of people in the survey disapproved of the president’s practice of putting tariffs on goods imported from other countries, and 66% of people disapproved of America’s withdrawal from the Paris Accords and its position in the fight against climate change more broadly. People also generally disliked the idea of building a wall on the border between Mexico and the United States, as well as the country’s withdrawal from the Iran nuclear deal. In fact, the only policy that people more people approved of than disapproved of was the opening of talks between the United States and North Korea, though even in this case less than half, 41%, of respondents approved of it whereas 36% disapproved.

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The U.S. president was ranked more favorably in right-leaning countries than in left-leaning ones, which is unsurprising given that U.S. politics is generally further to the right than those of the rest of the world. In countries that have displayed authoritarian tendencies, like the Philippines and India, Trump had the highest approval rating. In general, men were more likely than women to have a favorable opinion of Trump. In Ukraine, a country which has become relevant to the United States in the wake of the scandal that led to Trump’s impeachment, 73% of people surveyed had a positive view of the United States, although just 46% of people had a positive view of Trump specifically. His popularity in Israel specifically likely has to do with his decision to move the U.S. Embassy to Jerusalem as well as his decision to terminate the Iran nuclear deal, which is unpopular in Israel.

Though the survey reveals broadly negative views of Trump around the world, the president’s approval rating has actually increased since 2017, when just 22% of respondents expressed confidence in Trump. Given the tumultuous nature of modern-day global politics, it’s difficult to predict how these numbers will change as time goes on.