Posts tagged with "Vaccine"

Pfizer coronavirus vaccination article illustration by Kaelen Felix for 360 Magazine

Pfizer × BioNTech near historic vaccine

By Althea Champion

Pfizer and BioNTech announced on Monday that their COVID-19 vaccine is more than 90 percent effective. If approved, it could potentially be available to the public by early December, according to Dr. Anthony Fauci.

The results came out of Pfizer’s Phase 3 trial, which involved 40,000 individuals. Of those participating, 94 contracted COVID-19. These results, like much of 2020, are historic. Vaccines have never been developed on such a fast-moving timeline. The last vaccine that was developed in such considerable haste was for mumps, and it took four years.

Pfizer says that they plan to ask the Federal Drug Administration for emergency use by the end of the month. The vaccine will require two doses administered three weeks apart. The company hopes to have enough doses for 25 million people by the end of the year, and 650 million people in 2021.

In the case that the vaccine supply is limited, the C.D.C. will first vaccinate healthcare personnel, essential workers, people who are at high risk for severe COVID-19 illness due to underlying medical conditions, as well as those 65 years and older.

An expedited timeline does not mean drug companies are cutting corners. Fauci, like many of his colleagues in Washington, assures that manufacturers will stick to a process of vaccine development that ensures the safety of patients. The FDA will still make the final call.

“Today is a great day for science and humanity,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in Pfizer’s press release. “The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.”

However, a few questions remain unanswered.

“Historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions,” writes Arthur Allen in the Opinion section of the NYT. “Not through company press releases.”

According to Allen, it is unclear from the press release how long Pfizer’s vaccine will keep patients protected, if it is safe for high-risk populations like the elderly, or if rare side effects can arise in patients who are vaccinated. He notes that the Novavax and Sanofi Pasteur vaccines may be safer for older patients.

Novavax and Sanofi Pasteur are subunit vaccines, like the hepatitis B vaccine. They deliver only the essential antigens of the virus to the immune system, so it learns how to attack it. Because it is only a part, or a subunit, of the virus, fewer side effects are likely.

Pfizer’s is a nucleic acid vaccine that uses RNA. According to the Washington Post, “this type of vaccine contains a strip of genetic material within a fat bubble” that enters the cell. Once inside, “the RNA generates a protein found on the surface of the virus.” It can then familiarize itself with the virus and learn how to fight it.

Moderna’s vaccine is also an RNA vaccine in Phase 3 trials. Pfizer’s success bodes very well for Moderna, according to a statement Fauci made to CNN.

Furthermore, because the vaccine must be stored in extremely low temperatures—on dry ice at negative 100 degrees Fahrenheit according to the Washington Post—its roll-out becomes complicated. If left out in the sun, or just at room temperature, or even at just below freezing, the mRNA self-destructs and the vaccine becomes useless.

Shortly after Pfizer’s announcement, President-elect Joe Biden addressed the nation, warned of the “dark winter” ahead, and urged Americans, regardless of party affiliation, to wear a mask until the vaccine is available.

The head of the C.D.C. warned this fall, that “for the foreseeable future, a mask remains the most potent weapon against the virus,” he said from the podium. “Today’s news does not change that urgent reality.”

Mina Tocalini, 360 Magazine, COVID-19

How States Can Combat COVID While Fighting The Flu

United States of Care Offers Suggestions to States on How To Deal With the Seasonal Flu Amid a Pandemic

(Washington, DC) Today, United States of Care (USofCare) issued a “Preparing for COVID-19 and the Flu,” recommendations to states for dealing with the seasonal flu amid a global public health crisis caused by the novel coronavirus.

“States have a long history of successfully dealing with the flu virus, encouraging vaccines and stopping a widespread flu outbreak,” said Emily Barson, Executive Director of United States of Care. “This year is different, as the nation’s already taxed health care system faces the unprecedented double whammy of influenza and COVID-19. As an organization engaging in one-on-one conversations with people, policymakers, and various health care leaders throughout the pandemic, United States of Care offers a unique view on what people need to know and what states can do to combat COVID-19 while fighting the flu.”

United States of Care’s “Preparing for COVID-19 and the Flu” breaks down how states can prepare for dealing with the flu and COVID-19 simultaneously. It includes the following suggestions:

  1. Communicate Clearly: State leaders need to be clear in their communications about why protective measures, such as mask requirements and closures, are necessary to keep people safe from the flu and COVID-19. States can play a vital role in providing people with clarity about what to do if they are infected with either the flu or COVID-19, as they have similar symptoms
  2. Prepare for Increased Health Care Demand: States need to have contingency plans in place so that health care system resources can be efficiently allocated.
  3. Address the Needs of High-Risk People: States will need to continually rely on the latest COVID-19 metrics and data on the flu’s trajectory, especially for high-risk populations to take additional measures.
  4. Develop Plans to Increase Influenza Vaccination Rates: In a typical flu season, less than 50% of people get vaccinated, and the rate is even lower among people of color. Increasing this rate is essential to minimizing the strain on our health care system. Clear communications are also vital due to people’s ongoing concerns about receiving medical care during the pandemic. States will need to develop plans to distribute flu shots in safe-settings, including at home for vulnerable populations.

Hiccup in COVID-19 Vaccine Development

By Althea Champion

In a statement from AstraZeneca, reported by STAT News, the biopharmaceutical company reported a halt in their global research trial. The company, which is working with the University of Oxford and is one of the few waist-deep in the process of developing a COVID-19 vaccination, reported that the halt is a “routine action which has to happen whenever there is a potentially unexplained illness in one of the trials.”

The company is in Phase 3 of their clinical trial in the U.S., as well as Brazil and South Africa, according to the New York Times, and in Phase 2/3 in England and India. AstraZeneca began the third phase of its clinical trial not much longer than a week ago, on Aug. 31.

Phase 3 efficacy trials involve thousands of volunteers, some of which are administered the vaccine in question, and others the placebo.

AstraZeneca and its most close competitors, Moderna and Pfizer, which have each been in phase 3 of their clinical trials since July 27, are backed by the Trump administration’s Operation Warp Speed, a targeted allocation of resources meant to hasten the development of a COVID-19 vaccine. 

The halt of AstraZeneca’s COVID-19 vaccine—AZD1222—is the first made public by its drug maker, and will allow a safety review to take place. 

“A volunteer in the U.K. trial [of AZD1222] had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections,” reported the New York Times. “However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is unclear.”

The vaccine was first developed by Oxford University’s Jenner Institute and Oxford Vaccine Group, according to nih.gov, and was then “licensed to AstraZeneca for further development.” Oxford-Astrazeneca began the third phase of its clinical trial not much longer than a week ago, on Aug. 31

The company stressed in its statement that the safety of their participants is a priority.

“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” said the company in their statement. “We are committed to the safety of our participants and the highest standards of conduct in our trials.”

Allison Christensen Illustrates a Sports Article for 360 MAGAZINE

2020 Summer Olympics

by Justin Lyons

The 2020 Summer Olympics in Tokyo are following the old show business gospel of “the show must go on.”

John Coates, vice president of the International Olympic Committee, spoke with AFP to say the Olympics would indeed begin in July 2021, whether COVID-19 is still around or not.

The summer games were originally scheduled to take place this summer, but complications from COVID-19 delayed them until next year.

Coates said the next Olympiad will be “the Games that conquered COVID.”

According to BBC, chief executive of the Tokyo Games Toshiro Muto also said it was possible for a limited audience to be in attendance and wanted to avoid having no spectators.

BBC also reported that Muto said a vaccine was not necessary for the games to go on.

Sports were warmly welcomed back in the United States in July, and the National Football League will return this week. Though basketball, baseball and hockey are finishing their seasons without fans, plan for fans in football stadiums remain tentative.

Fans around the country will have their eyes on the situation, and we obviously hope to see fans cheering on their home countries next year in one of the most unifying events in the world if conditions so permit.

Jean Button illustrated by Mina Tocalini for 360 MAGAZINE.

Covid-19 on Clothes

By Eamonn Burke

As a relatively new virus, new information is coming out about Covid-19 every day. While much is known, such as the fact that it spreads through air and is most dangerous to the elderly, there is much that remains unknown.

One of these unanswered questions is that if clothing: can the coronavirus survive on clothing? What we do know from evidence is that the virus can in fact live on other surfaces like plastic and steel for up to nine days. There is no evidence, however, that answers the question about clothes.

What we do know is that viruses similar to Covid – MERS, SARS – do not survive on clothes, as they are porous surfaces that can trap the virus and dry it out. A study from Johns Hopkins Medicine corroborates this, finding the probability of the virus being transferred through clothing is low. However, another study did find that the virus can live on shoes.

While the most important protective measures against COVID-19 remain social distancing and wearing masks, the CDC still recommends to air on the side of caution and wash clothes, specifically on the warmest setting to dry them out. The findings also pose issue for companies who need to handle clothing returns. Many large companies like Macy’s and Gap have amended their return policies to consider this, but it is also important for small businesses to do the same.

Covid and health illustration

Oxford Vaccine Shows Promising Signs

By Eamonn Burke

A vaccine developed by The University of Oxford in the UK and major pharmaceutical company AstraZeneca has shown early signs of being a potential success. According to data posted today in The Lancet medical journal, a strong immune response was invoked by early testing of the vaccine in a large human trial of over 1,000 participants.

The vaccine, named ChAdOx1 nCoV-19, produced higher levels of antibodies and T-cells that fight the virus, according to the data. In other words, “We’re stimulating both arms of the immune system,” says Oxford’s head of the Jenner Institute Adrian Hill.

By no means does this data guarantee an effective vaccine, but human testing is a major step in the right direction, especially one with positive results. Another good sign is the lack of serious side effects, with most volunteers only reporting fatigue, headache, and soreness at the injection site. Big questions that remain, however, are how the body will react once infected, and if someone can get infected again.

AstraZenaca has received support from the U.S., pledging $1.2 billion dollars to vaccine work, and from the U.K., who has made a deal for 90 million doses of it. It is one of over 100 being developed globally, with 23 in the human trial phase. One of them is Moderna’s, which also showed promising signs in data last week and is set to start a Phase 3 of development on July 27.

Mina Tocalini illustration for 360 MAGAZINE HEALTH SECTION.

Coronavirus Conundrums: Where do we go from here?

The following interview is courtesy of Special Guests.

We are faced with lots of new questions as the COVID pandemic continues: Back to school? Wear a mask? Virus Mutations? Cases Skyrocketing? Our guest is Dr. Charles Page, a surgeon from Texas who is here to help us make sense of what appears to be so nonsensical.

Q&A:

1) Dr. Page, can you give us a big picture of where we are in the pandemic?

Answer: The wave is progressing from the epicenter (NYC) out into the rest of the US. In my opinion, this is not a Second Wave or a mutated virus but a progression of the same virus.

2) The number of coronavirus cases is skyrocketing, primarily because of increased testing availability. How does the death toll correlate to this increase in cases?

Answer: Fortunately, the death toll hasn’t followed that pattern. The death rate is stable. That’s good news. At the present our ICU’s and hospitals(at least in Texas) are not overwhelmed with cases. No need for panic.

3) What about a vaccine?

Answer: We are still getting closer to a vaccine. The NIH started enrollment for people to receive vaccines in clinical studies (as of 7/8/20).

The COVPN (Covid Prevention Trials Network). Bringing together these four groups to begin phase 3 clinical trials will streamline the process for a vaccine.

4) Can you give us your opinion on the safety of reopening schools in the fall?

Answer: We have to base our opinions on facts—not feelings (or politics). There are several international studies that show it is safe for kids to return to school. Studies in Iceland, China and New Zealand showed that: children are particularly resilient to the disease (they have minimal symptoms) and for some reason, they rarely transmit COVID to others. This has been corroborated by multiple studies.

5) So, what’s the issue?

Answer: Kid’s immune systems are more resilient than those of adults. Their systems are in the phase of processing and developing immunity to new pathogens. Isolation/quarantine may, in the long run, be more harmful. I feel comfortable having my 12 and 18-year-old kids go back to school —without a mask.

6) What do you think about masks?

Answer: There’s not a lot of science behind wearing a mask. We are still in uncharted waters. Most of the studies done are in hospitals and health care institutions. With that being said, in many states (like Texas) it’s the law. Our states haven’t flip-flopped. If you recall, at the onset of the pandemic, we were short on resources and didn’t have enough masks. Now we do. The literature confirms that masks catch many respiratory droplets, keeping them from spreading in the air. So if someone has disease, it diminishes the spread. But wearing a mask doesn’t keep you from getting the disease.

About Dr. Charles Page

Dr. Page is the best guy to see on the worst day of your life. He is a surgeon from Texas and co-host of the podcast, “Life’s about Living,” a show for retirees and Boomers.

His book, A Spoonful of Courage for the Sick and Suffering, is a compilation of faith-based inspirational stories helping the ill see the possibilities in their problems.

Visit his website HERE.

Coronavirus Vaccine – Dr. Jeremy M. Levin

A story in USA Today this morning asks whether a coronavirus vaccine could repair the pharma industry’s reputation despite drug price increases. Dr. Jeremy M. Levin, an iconic biotech thought-leader who first introduced immuno oncology to the world 10 years ago, is quoted:

“The pandemic ‘has driven the public eye onto what the biotech industry does, which is change the dynamic of a disease,’ said Jeremy Levin, chairman of BIO and author of the recently published book Biotechnology in the Time of COVID-19: Commentaries from the Front Line. “In the noise that came from the bad actors, we basically lost sight of the essence of what the biotech is all about, which is patients and innovation.”

Here are some additional thoughts from Dr. Levin’s on developing a vaccine and the road forward:

What can you (and the biotech industry) tell the American people that they haven’t already heard? Unless we are able to get a handle on COVID-19, we as a society as a whole are at great risk. There has never been a greater risk from a transmissible disease to our nation, and the world at large.

There is incredible pressure to expedite a COVID-19 vaccine, even if it hasn’t been tested in the way it needs to be tested.

What are the risks/rewards? The risks of rushing a vaccine are  considerable, and the FDA will be acutely aware of this when making an approval. I expect there will be extraordinary diligence from the FDA, as well as from each company producing a vaccine. Despite this, the risk of not developing a vaccine are nearly unimaginable.

How long is the typical timeline for vaccine development? A typical timeline for vaccine development is at least a decade, but many variables go into this. This article in the NY Times is a useful explainer.

Dr. Levin is available for interviews on COVID-19 and other biotech topics. He is currently CEO and Chairman of OVID Therapeutics, Inc., and Chair of the global Biotechnology Innovation Organization (BIO). In 2018 Dr. Levin was named “one of the most influential figures in biopharmaceutical industry” by FierceBiotech, and one of the top three biotechnology CEOs in 2020 by The Healthcare Technology Report. See him interviewed HERE on CNBC.

Mina Tocalini, 360 Magazine, COVID-19

Gates – COVID-19 Vaccine

By Jason Tayer

As the Black Lives Matter movement joined the COVID-19 pandemic in serving as two of the world’s most pressing current crises, they have undoubtedly merged in terms of their effects and implications on each other. The core issue driving the BLM movement deals with inequity and disproportionate treatment of black people compared to other populations in the U.S. In light of this notion, the coronavirus has been disproportionately affecting black populations across the country, and resembles a clear example of how we need mass social change.

Bill and Melinda Gates spoke out about how to better treat black communities in terms of handling the spread of COVID-19. According to Reuters, there have been several posts claiming that Melinda wants to test the vaccine on black communities. However, deeper analysis has shown that this was a misinterpretation and that she meant to communicate that once the vaccine is safe to distribute, healthcare workers and black populations should be first priority recipients of the vaccine since they have both been unequally affected by COVID-19 cases. For instance, the state of Illinois recorded that 30% of its COVID-19 cases were held by black people when they only make up 14.6% of the population.

TIME Magazine states that since there has been a lack of ties to international health agencies within this country, Bill Gates announced that the Gates Foundation will give $1.6 to the Vaccine Alliance. This effort to bring forth an appropriate vaccine as soon as possible compliments the intentions to equitably distribute the vaccine to particularly impacted communities once it is made available.