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Experts Warn Omicron Covid Variant Is A ‘Reason To Be Worried’

The Omicron Covid-19 variant was first detected in South Africa, and has now spread to 14 countries, with some experts claiming the variant has already reached the US. Scientists are working to figure out how much more dangerous and contagious the new variant is when compared to other variants, especially as international governments race to ease travel restrictions. 

The US has been imposing travel restrictions on travelers from South Africa since Monday, as well as other countries around the region. The variant has already been confirmed in Canada, and Dr. Scott Gottlieb, former head of the Food and Drug Administration, discussed the variant on the news recently. 

“The new variant is likely already in the United States, but the government is better positioned to detect cases of the new strain than it was a year ago.”

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As of this week, most travelers from southern Africa are barred from entering the United States, and restrictions have been renewed for all travel from southern Africa to most European countries. Within 36 hours of discovering the new strain, scientists in South Africa alerted the world and began testing current vaccines against the strain immediately. Dr. Anthony Fauci discussed the increased risk for unvaccinated Americans when it comes to any variant. 

“The US certainly has the potential to go into a fifth wave of high infections if enough people don’t come forward for vaccination and booster shots.”

South Africa’s government and president, however, are worried that the region is being unjustly blamed for the new variant, when the reality is these variants only have the opportunity to develop due to uneven distribution of the Covid-19 vaccines throughout the world. 

“We want all travel bans to be reversed, as they have no basis in science. These restrictions are completely unjustified and unfairly discriminate against our country,” South Africa’s President Cyril Ramaphosa said. 

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“I think there’s good reason to be worried. I don’t think that means that we’re powerless, answers are coming. We need to collect data. We need to investigate and understand this variant,” said Professor Anne Van Gottberg of South Africa’s Institute for Communicable Diseases.

“We should be doing the things that we know work when you’re dealing with a pandemic virus. It’s not the time to panic. We should be concerned, and our concern should spur us to do the things that we know work,” Dr. Fauci said.

Fauci explained that “the concern over the new variant comes from the number and type of mutations found around the spike protein, the part of the virus molecule that allows it to attach itself to human cells. The high number of mutations and where they were found suggests that this would be more transmissible, and also suggests that it might evade some of the immune parameters that we have, such as antibody and plasma treatments, and the current vaccines.”

“It appears to be spreading very readily and has a transmission advantage. One of the key things we don’t know right now is whether the new variant causes more severe COVID-19 symptoms than previous strains.”

Omicron currently accounts for more than 2,000 new daily cases in South Africa. One expert in the nation is worried that the daily infection rate could triple within the next week alone. 

“I am expecting we will top over 10,000 cases by the end of the week per day,” Dr Salim Abdool Karim said during an online press briefing by the Health Ministry.

President Biden’s Vaccine Mandate For 100 Million Workers Officially Being Enforced

Back in September President Biden announced that he would be working on creating multiple vaccine mandates to get more Americans vaccinated. On Thursday, the administration started the process by releasing mandates for over 100 million workers. 

The first rule has been issued by the Occupational Safety and Health Administration (OSHA), and covers mandates for companies with 100 or more employees; it’s estimated this rule will apply to 84 million workers. Companies need to ensure their employees are fully vaccinated against Covid-19 by January 4th, or they will need to provide a negative test in order to come into work every week. 

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OSHA’s rule also requires employers to pay their employees for the time it takes for them to get vaccinated, and recover from any potential side effects that arise. 

Employers also won’t be required to pay for weekly testing for their unvaccinated employees, or even provide the testing in the first place. This is in an attempt to get more employees to actually receive their vaccines as opposed to remaining at higher risk for exposure. 

Unvaccinated workers will also be required to wear face coverings at all times; this rule will be enforced starting December 6th. 

The Centers for Medicare & Medicaid Services are requiring around 17 million health care workers to be vaccinated by January 4th. However, healthcare workers won’t be given the option to decline being vaccinated to opt for weekly testing. 

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Some employers are worried that the deadlines OSHA provided won’t give some of them enough time to gather the information required to find out who’s already vaccinated and who’s not. However, the Biden Administration asserted their authority in issuing these mandates due to OSHA’s responsibility to provide safe and healthy working conditions for all employees. 

“A virus that has killed more than 745,000 Americans, with more than 70,000 new cases per day currently, is clearly a health hazard that poses a grave danger to workers,” said a senior administration official.

Companies will mainly be responsible for enforcing the OSHA rule, as there’s only a couple thousand state and federal OSHA inspectors nationwide. It’s expected that OSHA inspectors will more likely be responding to employee complaints regarding their employers or fellow workers who aren’t abiding by the mandates. 

Employers that violate the rule can face fines up to $13,000 per violation, and depending on how severe the violation is that fine could multiply by ten.

WHO, CDC Warn Measles Outbreak Possible After 22 Million Infants Miss Their Vaccines

A study published by the United States Center for Disease Control (CDC) shows the possibility of a global measles outbreak has increased after 22 million infants missed their vaccinations because of the COVID-19 pandemic in 2020, 3 million more than in 2019.

Two-thirds of the infants are located in just ten countries, which include Pakistan, Afghanistan, Nigeria, India, Indonesia, Brazil, the Philippines, the Democratic Republic of the Congo, Angola, and Ethiopia.

According to the World Health Organization, measles are the world’s most contagious virus, but also the most “entirely preventable,” with the vaccine having averted more than 30 million deaths over the last 20 years.

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After a global measles resurgence from 2017-2019, the disease saw a drop in 2020 due to the pandemic. In the U.S., just 13 individual cases of measles were confirmed in 2020, down from 1,282 reported cases in 2019. However, the CDC notes that despite the decline, millions of children were more susceptible to measles at the end of 2020 than they were at the end of 2019.

There were a number of possible causes for the measles decline in 2020, one of them being lower transmission rates — thanks in part to social distancing and quarantining — and increased immunity. However, a more likely culprit is the underreporting of cases after “large and disruptive measles outbreaks in 2020.”

Per the WHO, despite there being a safe and cost-effective measles vaccination, there were 140,000 measles deaths globally in 2018, mostly among children under the age of five. On average, there are around 60,000 measles deaths a year, along with 7.5 million cases.

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The measles vaccine come in two doses, which is critical for it to be successful. The first dose coverage fell in 2020, while only 70% of children received their second vaccine dose, which the WHO explains is far below the 95% coverage needed to protect communities from a measles outbreak.

According to The Hill, the number of specimens sent to the WHO Global Measles and Rubella Laboratory Network hit a low that hasn’t been seen in more than a decade. 35 countries did not report rates for the first measles shot, while 50 countries did not report rates for the second measles shot.

In addition to the missed vaccines by infants, 24 measles vaccine supplemental campaigns in 23 countries were postponed due to COVID-19, leaving more than 93 million people at risk for the virus. These campaigns are important because they’re needed where people have missed out on measles-containing vaccines through routine immunization program.

In a statement, WHO Director of Immunization Dr. Kate O’Brien explained we are likely seeing “the calm before the storm” when it comes to a measles outbreak, and stressed the importance of continual vaccination against all diseases.

“It’s critical that countries vaccinate as quickly as possible against COVID-19, but this requires new resources so that it does not come at the cost of essential immunization programs. Routine immunization must be protected and strengthened; otherwise, we risk trading one deadly disease for another.”

Along with the risk of death, measles can also cause swelling, blindness, pneumonia, dehydration, diarrhea, and encephalitis, which can cause swelling of the brain. More basic symptoms include a high fever and rashes.

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.

White Pill

Experts Are Hopeful Over Covid-19 Antiviral Pill, But Emphasize Vaccines Are Still Our Way Out Of The Pandemic 

Merck and Ridgeback Biotherapeutics announced this past week that they created an antiviral pill that can reduce Covid-19 hospitalization and death by 50%. Experts believe this pill could be a “game-changer” in the way we treat Covid, however, they’re also emphasizing that this pill is not an alternative to getting vaccinated, and vaccinations against the coronavirus arte the most effective way Americans can bring this pandemic to an end. 

Over 255,000 Americans are becoming fully vaccinated every day, according to data from the US Centers for Disease Control and Prevention. About 65% of Americans are now fully vaccinated. On the opposite end, the US surpassed 700,000 Covid-related deaths this week, according to data from Johns Hopkins University. The US is currently the world’s leader in Covid deaths. 

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“This new antiviral pill can be used in conjunction with the vaccine. And it’s not an alternative to vaccination. We still have to try to get more people vaccinated. The antiviral medicine could be effective for those who choose not to get vaccinated, as well as those who catch the virus while fully vaccinated,” explained Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration. 

“This is the most impactful result that I remember seeing of an orally available drug in the treatment of a respiratory pathogen, perhaps ever. I think getting an oral pill that can inhibit viral replication — that can inhibit this virus — is going to be a real game-changer.”

Merck is now seeking FDA emergency use authorization for its medication, and if it’s permitted, it will become the first oral medicine that fights viral infection for Covid-19. 

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“If approved, I think the right way to think about this is; this is a potential additional tool in our toolbox to protect people from the worst outcomes of Covid. Inoculation remains our best tool against Covid-19 because the shots can prevent people from getting infected in the first place, and we want to prevent infections, not just wait to treat them once they happen,” White House Covid-19 Response Coordinator Jeff Zients said.

The FDA is also meeting with its Vaccines and Related Biological Products Advisory Committee on October 14th and 15th to discuss booster shots for Americans who received the Moderna or Johnson & Johnson vaccine. 

The FDA’s vaccine committee is also set to discuss approving Pfizer’s Covid-19 vaccine for children ages 5 to 11. The company has already begun submitting data about that specific age group. 

Vaccine mandates are beginning to appear all throughout the country as well as a means of getting more Americans to receive their inoculations so the nation has an actual fighting chance at bringing this pandemic to an end.

Study Says Merck COVID-19 Pill Cuts Risks Of Hospitalization, Death In Half

According to results of a clinical trial released, an experimental COVID-19 pill known as molnupiravir could assist in cutting the chances of hospitalization or death for at-risk patients by up to 50%.

Merck & Co., the pharmaceutical company that developed the pill in partnership with Ridgeback Biotherapeutics, announced in a press release that it is planning to submit an application for Emergency Use Authorization (EUA) to the Food and Drug Administration (FDA).

Merck stated that it expects to produce 10 million courses of molnupiravir by the end of 2021, with more courses on the way in 2022.

Back in June, Merck announced a procurement agreement with the U.S. Government, where the company would supply 1.7 million molnupiravir courses at the cost of $1.2 billion. Merck is also discussing supply and purchase agreements with other governments worldwide.

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If the EUA is approved by the FDA, molnupiravir will be the first oral medicine made available to combat the risks of COVID-19. The pill will require a prescription, and is intended for those with mild to moderate COVID-19 symptoms.

ScienceDaily detailed how molnupiravir works, with the agent targeting the RNA genomes of the COVID-19 virus:

“When it [Molnupiravir] enters the cell, it is converted into RNA-like building blocks. In the first phase, the viral copying machine, called RNA polymerase, incorporates these building blocks into the RNA genome of the virus. However, unlike Remdesivir, which slows down the viral RNA polymerase, Molnupiravir does not directly interfere with the function of the copying machine. Instead, in the second phase, the RNA-like building blocks connect with the building blocks of the viral genetic material.”

Thanks to multiple mutations in the replications of viral RNA, pathogens are thus rendered unreproducible.

Merck noted that in their “MOVe-OUT” study, which consisted of 1,550 patients with varying COVID-19 symptoms and underlying conditions, only 7.3% of participants (28 out of 385) who received molnupiravir were hospitalized or died.

That number was significantly lower than the 14.1% of participants (53 out of 377) who were hospitalized or died while being treated with placebo. Additionally, no molnupiravir patients died through the 29th day, as opposed to eight placebo deaths.

Wendy Holman, the chief executive officer of Ridgeback, stressed how important it is to have a form of antiviral medicine that isn’t intertwined with healthcare facilities, which are currently swamped with COVID-19 related cases.

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According to Our World In Data, there are over 71,000 COVID-19 patients that are currently hospitalized in the United States. Despite hitting just around the 12,000s in July, the lowest hospitalization total in over a year, the U.S. saw that number skyrocket to nearly 99,000 in early September.

For a country that has dealt with wave after wave of the virus for months on end, it is hard not to be excited by the game-changing developments that molnupiravir could bring. It’s easy-to-obtain, practical nature could be attractive to those who have been hesitant of vaccination, or cannot take the vaccine for medical or personal reasons.

While vaccines remain the best method of protection against COVID-19, alternatives in any form are sorely needed in order to help speed up recovery processes and assist in preventing deadlier cases.

Merck and Ridgeback are not the only pharmaceuticals that have been developing COVID-19 oral drugs. Pfizer Inc., which started the first phase of their oral agent in March, is close to reporting clinical trial results, as is Swiss Roche Pharmaceuticals.

According to Retuers, Enanta Pharmaceuticals, Pardes Biosciences, and Japan-based Shionogi & Co. are all in the processes of producing oral treatments as well. Rest assured, there should be no shortage of medicine such as molnupiravir.

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.  

US To Ease Travel Restrictions For Fully Vaccinated International Visitors

Jeff Zients, White House Covid-19 response coordinator, said the new rules will take effect in November to give agencies and airlines enough time to prepare for the influx of travel that will likely come from these new standards.

President Biden Announces New Vaccine Mandate For Working Americans 

President Joe Biden announced this week that he would be imposing a new stringent set of vaccine requirements for federal workers, large employers, and health care staff in an attempt to slow the spread of Covid-19. 

The new requirement is set to apply to over 100 million Americans; about two-thirds of the workforce in the nation. 

“We’ve been patient, but our patience is wearing thin, and your refusal has cost all of us. Vaccinated America is growing frustrated with the 80 million people who have not received shots and are fueling the spread of the virus. While America is in much better shape than it was seven months ago when I took office, I need to tell you a second fact: We’re in a tough stretch and it could last for a while,” Biden said.

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The new plan requires the Labor Department to force businesses with 100 or more employees to either get everyone vaccinated or get tested once a week. Companies that refuse could face thousands of dollars in fines per employee who refuses to comply.

Biden also signed an executive order that requires every government employee to be vaccinated against Covid-19, and they can’t opt for regular testing. The same standard will also be applied to employees of contractors who do business with the federal government. 

“300,000 educators in federal Head Start programs must be vaccinated, governors need to require vaccinations for school teachers and staff. The 17 million health care workers at facilities receiving funds from Medicare and Medicaid will also need to be fully vaccinated, we’re expanding the mandate to hospitals, home care facilities and dialysis centers around the country. We have the tools to combat the virus if we come together to use those tools,” Biden said.

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The new “emergency temporary standard” from the Labor Department will also require all large employers to give their employees paid time off to receive their vaccines if they haven’t done so yet.  “If businesses don’t comply, the government will take enforcement actions, which could include substantial fines up to nearly $14,000 per violation,” according to officials.

“Each employer will decide exactly what they want to do, but what we’re saying through the Department of Labor rule making process is a minimum of testing once a week or full vaccination,” a senior administration official said.

“Federal employees will have 75 days to get vaccinated or risk being fired. The expectation is if you want to work in the federal government or want to be a contractor, you need to be vaccinated,” press secretary Jen Psaki said.

Additionally, Biden announced a slew of new health and safety measures as a means of slowing the spread of the Delta variant. The Defense Production Act will be evoked in order to accelerate the production of rapid Covid tests. The administration is hoping to send 25 million free tests to US health clinics. 

Biden overall unveiled a six-pillar plan to cobatting the pandemic. According to reports, “The six pillars of Biden’s plan include: vaccinating the unvaccinated; further protecting the vaccinated through booster shots; keeping schools open; increasing testing and requiring masks; protecting the economic recovery; and improving care for those with Covid-19.”