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CDC Expected To Release New Guidelines For Vaccinated Americans 

The US Centers for Disease Control and Prevention announced plans to release new guidelines this week specifically for how vaccinated Americans can safely alter their behaviors and live their lives safely without endangering themselves or other individuals who are still waiting to be vaccinated. 

The recommendations are expected to tell vaccinated individuals that they can host small, at-home gatherings with other fully vaccinated individuals. Two senior White House officials involved in drafting these guidelines spoke with the press about these projected guidelines. 

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Fully vaccinated people will still be asked to wear masks and social distance in public until a greater herd immunity is met. It’s expected that these new guidelines will officially be released this Thursday. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recently hinted at the possibility of new CDC rules during a press conference this week. 

“I use the example of a daughter coming in from out of town who is doubly vaccinated, and a husband and wife doubly vaccinated, and maybe a next-door neighbor who you know are doubly vaccinated. Small gatherings in the home of people, I think you can clearly feel that the risk — the relative risk — is so low that you would not have to wear a mask, that you could have a good social gathering within the home,” Fauci explained. 

Dr. Rochelle Walensky is the director of the CDC who spoke at the same conference as Fauci and warned that vaccinated Americans still need to be vigilant when it comes to abiding by health and safety procedures in public. 

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“While we may have guidance at the individual level, as Dr. Fauci has suggested, I think we all need to keep our eye on the fact that we’re not out of the woods yet.” 

Average daily coronavirus cases have fallen by roughly 65% since the start of January, however, new cases are still steadily appearing at an average rate of about 70,000 per day. “If Americans suddenly decided that because cases are going down, they felt more comfortable eating inside at a restaurant or socializing outside their pods, we could potentially erase the reductions that have been made over the past few weeks,” Dr. Kate Langwig, an infectious-disease ecologist, said. 

For now, Walensky wants Americans to know that “the goal is not to sort of open up travel just because vaccinations are scaling up. Instead, the Biden administration has set its sights on making sure that we are in a place to be out of this pandemic within President Joe Biden’s first 100 days in office — roughly by the end of April. However, at 70,000 cases per day, we’re not in that place right now.”

“The setting in a home of a small group of people having dinner together, all of whom are vaccinated, is very different when you step out the door and go into a society that has 70,000 new infections per day,” Fauci said.

Negative Covid Test

The US Is Requiring Negative Covid-19 Tests From All UK Travelers 

Any traveler from the United Kingdom coming into the United States will now need to arrive with a negative Covid-19 test result that was taken within three days of their flight. The Centers for Disease Control and Prevention (CDC) in the US recently released this new requirement along with other restrictions. 

This specific requirement went into effect this past Sunday and applies to any passenger who is currently eligible to fly from the UK to the US; this includes US citizens as well. Airlines are responsible for confirming the negative test results before and after boarding as well. According to the CDC airlines will need to confirm the date that the test was taken, the type of test taken, and that the test was negative. 

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Passengers have the option of either getting the nucleic acid amplification test, or the antigen test, but it must be one or the other in order to actually apply; rapid tests aren’t accurate enough to provide the approval for travel. 

Travelers who may be in a UK airport due to a layover, and who are there for less than 24 hours, are exempt from the rule. Additionally, travelers who have tested positive for the coronavirus and fully recovered with a confirmed negative test within the three months prior to travel are also exempt. 

The passengers who have recently recovered from Covid-19 must have proof of their prior positive test, negative test after their recovery, and a letter from a doctor clearing them for air travel. These requirements come after dozens of other countries around the world banned travel all together from the UK due to the discovery of a new strain of the coronavirus. 

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While the new strain of Covid-19 is also treatable with the slew of vaccines now being made available internationally, it’s thought that this strain is more contagious and severe when compared to the virus we’ve been battling throughout the past year. Individuals who have contracted the new strain often endure a more severe case of Covid, and are much more transmissible to individuals around them. 

The US resisted a total ban on travel between the two nations and initially declined to create any new requirements. It’s also already been discovered that this new strain is in the US, and it’s likely been here since September. 

“While it is known and expected that viruses constantly change through mutation leading to the emergence of new variants, preliminary analysis in the UK suggests that the discovered variant may be more transmissible than previously circulating variants, with an estimated potential to increase the transmissibility of the virus by up to 70%. This additional testing requirement will strengthen protection of the American public to improve their health and safety and ensure responsible international travel,” the CDC stated within the new set of guidelines. 

Once individuals get to the US the CDC recommends getting tested three to five days after arrival and self-quarantining for seven days even with a negative test result.

Moderna Vaccine

FDA Advisory Panel Officially Recommends Moderna’s Covid-19 Vaccine 

An advisory panel working for the Food and Drug Administration voted to recommend Moderna’s Covid-19 vaccine for emergency use authorization, nearly one week after Pfizer’s vaccine was approved. The panel itself isn’t a part of the FDA, but is a crucial part in the process of a new vaccine being approved for public consumption. 

The Vaccines and Related Biological Products Advisory Committee met this Thursday and unanimously voted 20-0 in favor of the vaccine’s approval. Now the FDA will review the committee’s analysis and trial data, like they did with Pfizer, and will likely start sending out the vaccine next week throughout the nation. 

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The committee’s unanimous vote indicates that each expert on the panel believes that the scientific evidence gathered from Moderna’s clinical trials prove the benefits of the vaccine outweigh the risks for individuals 18 years or older. Dr. James Hildreth is the president and CEO of Meharry Medical College in Nashville, Tennessee and was a member of the panel who recently spoke with the press about how hopeful he was after looking through all the data.

“To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement.” 

The committee’s main role is to provide solid advice to the FDA for moving forward in terms of vaccine distribution. Members have obviously been quite busy the past two weeks as now two vaccines are receiving the green light to be administered to Americans starting this month. For the Pfizer and BioNTech vaccine, frontline healthcare workers and other priority groups (nursing home residents) began receiving their initial doses this Monday. 

Panel member Dr. Hayley Gans, a pediatrician at Stanford University Medical Center and professor of pediatrics, claims that with Moderna’s vaccine “the evidence that has been studied in great detail highly outweighs any of the issues we’ve seen and it really supports us being able to put the pandemic in our background, really move forward and finally provides a safe and effective way to get to herd immunity.”

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The Moderna vaccine reportedly is 94% effective in providing immunity against the coronavirus; Pfizer’s is just as effective as well. One of the biggest hurdles that healthcare workers/vaccine administers have had to deal with in terms of Pfizer’s vaccine is the fact that it has to be stored at ultra-cold temperatures beyond what standard pharmaceutical freezers typically can handle.

Moderna’s vaccine, on the other hand, can be kept at a standard freezer temperature, which would make it much easier to store and allow it to be distributed to more vaccination sites throughout the nation who may not have the technology to store Pfizer’s vaccine. 

Both of the vaccines require two separate doses; the Pfizer vaccine’s second dose must be given 21 days after the first while Moderna’s can be given 28 days later. 

These vaccines couldn’t have come at a better time, as America is currently in the worst phase of the pandemic yet. More than 17 million people have been infected with Covid-19 and over 310,000 people have died. As case numbers surpass 100,000 daily and deaths surpass 1,000, the federal government is continuing to debate whether or not to give its citizens $600 or not and is continuing to allow the states to determine what establishments remain open to curb the spread. 

While President-elect Joe Biden has made numerous policy promises in terms of curbing the spread, he won’t be taking office for another month, and as we’ve seen, a lot of damage can be done in a month.

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.

African American Friends Wearing Masks

CDC Report Claims Systemic Racism Has Made Covid-19 Deadlier For Black Americans

According to an internal agency report from the Centers for Disease Control and Prevention (CDC), Black Americans are at a higher risk of contracting the coronavirus due to issues of fundamental racism.

Doctor Giving Coronavirus Vaccine

US Covid-19 Update: Vaccine To Be Approved Soon As Daily Death Rates Soar

The United States is likely to be celebrating a major milestone in the Covid-19 pandemic very soon, as the vaccine will likely be getting approved for emergency use very soon, and distribution can begin. The approval couldn’t come at a better time as the daily coronavirus death toll reached a record high of 3,124 this past Wednesday; surpassing the amount of American deaths that occurred on 9/11, and experts hear this is just the beginning of a massive final wave of infections. 

The US Centers for Disease Control and Prevention recently released a composite forecast that projects the US hitting up to 362,000 Covid-19 deaths by January 2nd. Hospitalizations reached a record high this week as well with over 106,000 Covid-related cases. More than 221,000 infections were also reported in a single day, which according to former Health and Human Services Secretary Kathleen Sebelius, is just the beginning. 

“We are in a totally unprecedented health crisis in this country. The disease is everywhere — Midwest, West Coast, East Coast, North, South. Health care workers are exhausted. Hospitals are totally full.”

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Vaccine advisers working for the US Food and Drug Administration are currently meeting to discuss the Pfizer coronavirus vaccine and will hopefully grant emergency use authorization by the end of the week so that Americans can start being vaccinated by the end of the month. 

According to Sebelius, Covid-19 vaccines are a “really significant light at the end of the tunnel, but in the coming months it’s crucial that Americans stay vigilant and follow safety guidelines, like wearing face masks, social distancing and hunkering down in their social bubbles. We’ve got to take what we’ve learned in the last eight months and really put it into practice, so we don’t continue to have this unthinkable death toll and disease too.”

“Let’s say we get 80% of the population vaccinated. I believe if we do it efficiently enough, by the time we get to the end of the summer we may actually have enough herd immunity protecting our society through the end of 2021.”

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One big challenge that the US could face, according to Dr. Anthony Fauci, is getting everyone to take the vaccine. As of right now there’s an underlying level of trust that a majority of the American people have seen the destruction and devastation this virus, and lack of political action, has taken on the country within the past year, which will then prompt them to take the vaccine. 

Federal, state, and local leaders are all doubling down on enforcing health and safety measures in their communities and will continue to do so even as the vaccine begins distribution. Another major fear that experts are concerned with is citizens thinking that just because they themselves are vaccinated, or the fact that people are being vaccinated in general, is enough for life to automatically return to normal. 

The reality is, we will likely have to be wearing masks and social distancing well into the end of 2021 based on how long it will take for enough of a herd immunity to be built in the US for all of us to be living our lives in close proximity without fear again. Within the next few weeks, it’s projected that about 20 million Americans will receive the PFizer vaccine. These individuals will likely all be healthcare industry workers or elderly people who are especially vulnerable to contracting Covid-19. 

In the UK thousands of individuals have already received the initial dose of the Pfizer vaccination, and Canada just approved it as well for emergency use authorization. The FDA is “not cutting any corners,” according to Fauci, before giving Pfizer the seal of approval, so for now, continue to listen to your healthcare providers and abide by all health and safety measures.

Covid-19 Immunity Passport

Covid-19 Passports May Be Key For Traveling In A Post-Pandemic World

Now that a multitude of companies are gearing up to distribute their Covid-19 vaccines in 2021, a lot of questions are being raised in regards to how we will navigate in a world during that transitional period where everyone’s waiting to be vaccinated.

Scientist Holding Moderna Vaccine

Moderna Applies For Emergency Use Authorization Of Covid-19 Vaccine In US And Europe

Moderna announced today that it would be asking US and European regulators to allow emergency use authorization of its Covid-19 vaccine. The submission is a result of new study data confirming that the shots offer a very strong protection against the coronavirus. 

Moderna quickly followed Pfizer in their announcement of the development of a vaccine, which is crucial considering multiple Covid-19 vaccines will need to be made available in order for the pandemic to come to a true close. Moderna created its shot treatment with the US National Institutes of Health, and according to the company this past weekend’s data showed that the vaccine is more than 94% effective. 

Within the massive US clinical trial that Moderna performed, 196 participants became infected with Covid-19. Of that number, 185 received the placebo vaccine, while the other 11 got the real vaccine. The only individuals who got severely ill with the virus were those who received the placebo as well, proving the vaccines effectiveness. Dr. Tal Zaks, one of Moderna’s chief medical officers, recently rejoiced with the media about this amazing advancement. 

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“I allowed myself to cry for the first time, we have already, just in the trial, saved lives. Just imagine the impact then multiplied to the people who can get this vaccine.”

Moderna claims that so far they’ve only seen temporary flu-like side effects come from the vaccine, the same type of symptoms that appear after getting a regular flu shot. The safety data up until this point has already met the US Food and Drug Administrations (FDA) requirements for emergency use, the company just needed to complete its final trial testing before it could have all the necessary information for the FDA’s review. 

The European Medicines Agency, which is like Europe’s version of the FDA, will also likely be granting Moderna with emergency use authorization in the coming weeks. Before the FDA approves either vaccine from Moderna or Pfizer a panel of scientific advisers will publicly debate if there’s enough evidence to release either or both vaccines to the public. 

Pfizer and German tech partner BioNTech will present their vaccine data to the FDA on December 10th and Moderna is set to present theirs on December 17th. If approved, Moderna expects to distribute 20 million doses within the US by the end of the year. Recipients need two doses, meaning the initial rounds will go to 10 million people. 

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Pfizer projects that they’ll be able to distribute 50 million doses throughout the world in December if approved; 12.5 million of those doses are reserved for the US. If the FDA approves of either of the vaccines they will begin being shipped within 24 hours. This week a panel of experts established by the US Centers for Disease Control and Prevention will also be meeting to decide how the vaccine will be distributed throughout the country once approved. 

The first doses will likely be reserved for health care workers who are at the most risk of exposure, and then will go to higher risk groups like the elderly and immunocompromised. As the vaccine’s continue in their development and distribution, other essential workers and individuals at higher risk for infection will receive their doses first. “Higher risk” could also be determined based on location and how severe the Covid-19 outbreaks have been for certain parts of the country. 

The UK ordered 40 million doses of the Pfizer-BioNTech vaccine, however, that doesn’t mean the company’s December supply will all be going to the UK at first. Like in the US, all parts of the world will have their own plans for distribution to higher risk/healthcare workers initially. Both Moderna and Pfizer have used messenger RNA from the Covid-19 virus itself to make their vaccines, which is why these two have likely proven to be the most effective around the same time. 

As the world continues to wait to see when and how these vaccines will be distributed, continue to listen to your healthcare providers and follow all the necessary precautions to protect yourself, and your loved ones.

COVID Virus Causes Deaths

The US Reports 2,100 Covid-19 Deaths In A Single Day 

Over 2,100 deaths were reported in the US this past Tuesday, marking the highest one-day coronavirus death toll the nation has reported since May. The highest Covid-19 death tally in a single day for the US was 2,603 back in April, however, the country hasn’t come close to that number since, until now. 

Cases and hospitalizations have been surging for a couple of weeks now, and officials are preparing for the worst in terms of new deaths. It’s been three weeks since the US has had less than 100,000 new Covid-19 cases appear in a single day. For the 15th consecutive day this week the US also beat its own record of Covid-19 hospitalizations; with over 88,000 patients in hospitals nationwide currently. 

Holiday celebrations have the nation’s leading healthcare experts even more worried. The US Centers for Disease Control and Prevention even released an official recommendation not to travel for Thanksgiving this year, and after a recent poll taken by Axios-Ipsos, about 61% of Americans have changed their Thanksgiving plans, and 1 in 10 Americans say they no longer plan to celebrate the holiday at all. 

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On the opposite, more concerning, end, more than 1 million travelers have already passed through airport security this past Sunday alone, according to the Transportation Security Administration. Dr. Jonathan Reiner, a professor of medicine at George Washington University, recently spoke with the press about how everyone needs to make adjustments for the holidays this year unless we want to continue to see this devastation occur. 

“People shouldn’t rely on a negative test to give them confidence to mingle with other households for Thanksgiving, because tests can miss the virus in the newly infected. Instead, people should have quarantined 14 days beforehand.”

America’s average daily death toll for a given week is 1,601; for comparison in the summer it was around 1,130. As daunting as these stats may seem healthcare experts are really more concerned with the coming weeks after Thanksgiving when even more cases start appearing. As a result, many states are implementing more restrictions to hopefully combat the surge that’s likely to come after the holidays. 

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New York City Mayor Bill de Blasio announced last week that all public schools would be closing and more restrictions would be on the way. In Nashville, Tennessee, the mayor limited restaurant and bar capacity to 50% with a 10 p.m. curfew. In El Paso, Texas, which has been hit particularly hard within the past month, County Judge Ricardo Samaniego announced a partial curfew for 10 p.m. 

The reality is, unless the country shuts down completely again, cases, hospitalizations, and deaths will continue to rise, and while multiple vaccine options are showing great promise for the spring, we still have a decent amount of time to go before Americans can expect to be vaccinated. 

Whenever a vaccine is officially approved by the FDA and CDC for distribution, health care workers and individuals at a higher risk of infection will receive the injections first, and then states with major Covid-19 hot spots will likely receive the next rounds. Dr. Anthony Fauci projects that the general public can expect to be vaccinated by spring/summer of 2021. In the meantime, however, we all need to do our part to curb the excess spreading we’re witnessing of this virus throughout the country. Wear a mask, stay home unless necessary, practice proper hand washing/hygiene, and social distance.

Pfizer Building

Pfizer To Submit Application For Covid-19 Vaccine Emergency Use Authorization Today 

Pfizer and BioNTech announced that they would be submitting an application for an emergency use authorization for their coronavirus vaccine to the US Food and Drug Administration (FDA) today. This is the first vaccine to seek a regulatory seal of approval in the United States. 

Pfizer said in a statement that their vaccine candidate, known as BNT162b2, will potentially be available for high-risk groups in the US by the end of December. The vaccine itself requires two doses that will be administered a few weeks apart, and full protection is achieved 28 days after the initial shot. 

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The submission to the FDA is based on the clinical trial results Pfizer finalized this week for their vaccine. The trial began in the US on July 27th and enrolled more than 43,000 volunteers worldwide. The final analysis of the vaccine showed that it was 95% effective in preventing infections with no serious safety concerns appearing, even in older adults. 

42% of the global participants and 30% of US participants in the Phase 3 portion of the study come from racially and ethnically diverse backgrounds, and 41% of global and 45% of US participants were ages 56 to 85. Pfizer CEO Albert Bourla recently released a statement about his company’s excitement over their filing. 

“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”

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Moderna is another pharmaceutical company who also recently released early clinical trial data that showed their Covid-19 vaccine as being 94.5% effective. Moderna is also projected to apply for EUA with the FDA later this month after it finalizes its safety data for the trial. 

An EUA won’t give the vaccine a full approval for public distribution, but instead allows the vaccine to be used under certain circumstances before all of the evidence is available for approval. The FDA has scheduled a meeting with its Vaccines and Related biological Products Advisory Committee, a group of outside experts, for December 8-10th, which is likely when an EUA decision will occur. 

According to the US Centers for Disease Control and Prevention (CDC), if the FDA authorizes the vaccines, they will be immediately distributed throughout the US, however, no one will be injected until a CDC advisory committee reviews the data and creates a plan for distribution/who will receive the vaccine first. 

The CDC advisory committee will have 48 hours to make a decision which will likely show healthcare professionals, doctors, nurses, and other workers that are directly on the frontlines of this pandemic receiving their immunizations first, and then higher risk immunocompromised individuals next.