Tag Archives: Vaccine

Top Five Global Investment Risks In 2021 | Charles Schwab

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The top five global risks for investors in 2021 are all surprises to the consensus view:

  • Problems with the vaccine rollout,
  • Geopolitical and trade tensions do not subside,
  • Fiscal and/or monetary policy tightens,
  • A “zombie” economy, and
  • Interest rate/dollar shock.

History demonstrates that the biggest financial risks in a typical year aren’t usually from out of left field (although a black swan did occur in 2020 with the COVID-19 outbreak). Rather, they are often hiding in plain sight.

Risk appears when there is a very high degree of confidence among market participants in a specific outcome that doesn’t pan out. So, by identifying the unexpected, here are the top five downside global risks for investors in 2021. To read more: https://www.schwab.com/resource-center/insights/content/top-five-global-investment-risks-2021?cmp=em-QYD

Be prepared

Whether or not these particular risks come to pass, a new year almost always brings surprises of one form or another. Having a well-balanced, diversified portfolio and being prepared with a plan in the event of an unexpected outcome are keys to successful investing.

References:

  1. https://www.schwab.com/resource-center/insights/content/top-five-global-investment-risks-2021?cmp=em-QYD

Vaccination and Wearing Masks

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“Once enough people have some immunity, either because of previous infection or because of vaccination, the virus will have a hard time spreading through the community.” Consumer Reports

Researchers hope that Americans getting vaccination will be sufficient to end the pandemic once there is sufficient supply and enough pf the population gets vaccinated.

In trying to understand the readily available vaccine information and how it will affect the lives of Americans, Consumer Reports has reviewed government guidance and consulted with public health experts to provide insight to their readers about the vaccine candidates.

Vaccination equals two doses

Vaccines require two doses—an initial shot and a booster, taken several weeks later. Generally with a two-dose vaccine, it takes about two weeks from the second dose for a vaccine’s protection to fully kick in, according to Natalie Dean, PhD, an assistant professor of biostatistics specializing in infectious disease and vaccine development at the University of Florida.

Though two doses are necessary, the FDA’s analysis of the Pfizer vaccine indicates that people appear to be somewhat less likely to get COVID-19 within two weeks of receiving the first dose.

It’s unclear how long protection from that first dose may last. And the second dose is still required for full protection, to ensure a more durable immune response. 

Halting the virus transmission

It is not known definitely whether getting vaccinated will prevent you from spreading the coronavirus to others. Thus, preventive measures such as social distancing, washing hands, and wearing a mask will remain important even after you get vaccinated, according to the CDC.

More research is required before scientists can say exactly how many people need to be vaccinated to achieve “herd immunity “. It’s possible that with extremely effective vaccines showing 95 percent efficacy, we might hit the point where communities are protected by the time somewhere between 60 and 70 percent of people have been vaccinated, according to Kathleen Neuzil, MD, a professor of vaccinology and director of the Center for Vaccine Development and Global Health at the University of Maryland in Baltimore. 

It will be possible for vaccines, as long as Americans get vaccinated, to have a significant impact on ending this pandemic.

Severe allergic reactions

In the U.K., public health regulators have advised that anyone with a history of a severe, potentially life-threatening allergic reaction to a vaccine, medicine, or food should not receive the vaccine. Two healthcare workers were reported to have had severe allergic reactions after receiving the vaccine. Public health experts worry that the reports could frighten people with allergies and make them think they should avoid getting the vaccine.

From Pfizer’s vaccine trial results, there were no severe allergic reactions. Deliberately, the trials excluded people who had previously had severe allergic reactions to vaccines, a Pfizer scientist said during the advisory panel’s discussion.

The FDA plans to advise that people who are allergic to components of the vaccine should not get it, an agency scientist explained. The FDA’s earlier review of Pfizer’s trial data found slightly more potential minor allergic reactions in the group that received the vaccine than in the placebo group, but none of these were severe, and none occurred immediately after people received their doses of vaccine.

References:

  1. https://www.consumerreports.org/vaccines/your-questions-about-a-coronavirus-vaccine-answered/?EXKEY=YSOCIAL_FB&fbclid=IwAR2LW6PC_JSykJwyG-Kv9ozQkNvxH-1VnYmAby-MJIr8kSJfHm7UwtyH3k8

mRNA Vaccine Safe and Its Side Effects

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Moderna and Pfizer COVID-19 vaccine trials show that side effects are common in participants and it appears that the more significant symptoms develop following the second dose.

The Pfizer-BioNTech’s mRNA coronavirus vaccine (BNT162b2) is both safe and effective, according to the U.S. Food and Drug Administration (FDA). FDA said results from Pfizer’s large, ongoing study showed the vaccine, which was co-developed with Germany’s BioNTech, demonstrated more than 95% efficacy across people of different ages, races and underlying health conditions, including diabetes and obesity. And partial protection from coronavirus appears to begin 12 days after the first dose, according to Pfizer. Consequently, Pfizer requested and the vaccines are expected to be approved for emergency use authorization (EUA) by the FDA as early as this week.

And this week, a committee of leading U.S. vaccine scientists recommended that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans.

FDA approval of a drug means that the agency will have determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling. Approval of the he vaccine will help reduce the risk of disease. The vaccine works with the body’s natural defenses to safely develop protection (immunity) to disease, according to the FDA’s website.

How an mRNA vaccine works

Messenger RNA vaccines, called mRNA for short, is a new kind of vaccine technology that has never before been licensed in the U.S. mRNA vaccines contain material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. The objective of a vaccine is to teach your immune systems how to recognize and fight the virus that causes COVID-19, according to the Centers for Disease Control and Prevention.

Messenger RNA vaccines aren’t like past seasonal influenza vaccines. An mRNA vaccine is essentially just a piece of genetic code that contains instructions for our body. The mRNA tells our cells to make a protein — the same protein that is the spike on top of the actual coronavirus. This is what triggers the immune response in these types of vaccines.

In contrast, past seasonal influenza vaccine puts a weakened or inactivated virus into your body to trigger an immune response, which then produces antibodies. Those antibodies are what ultimately protects you from getting infected if you ever encounter the real virus.

It typically takes a few weeks for the body to build immunity against COVID-19 infection after vaccination. And after vaccination, the process of building immunity can cause symptoms or “side effects”. These symptoms are normal and are a sign that the body is building immunity.

Side effects

Sometimes the vaccine process of teaching your immune system how to react to the virus can cause symptoms. These symptoms are normal and are a sign that the body is building immunity. Moreover, no major safety issues were uncovered and common vaccine-related side effects like fever, fatigue and injection site pain were tolerable, according to the FDA.

The most common vaccine side effects were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%), acc riding to the report submitted to the FDA.

Severe adverse reactions occurred in 0.0% to 4.6% of participants and appeared were more frequent after the second dose than after the first. The frequency of serious adverse events was low (<0.5%), without meaningful imbalances between study arms.

Although some COVID-19 trial participants reported COVID-like symptoms, it is impossible to contract the coronavirus from the vaccine, because the mRNA vaccines develop by Pfizer and Moderna don’t use the live virus. 

Bottomline

Getting vaccinated is one of many steps you can take to protect yourself and others from COVID-19.  Vaccines work with your immune system so your body will be ready to fight the virus if you are exposed.

References:

  1. https://www.cnbc.com/2020/12/08/pfizer-moderna-covid-vaccine-side-effects-trials.html?__source=iosappshare%7Ccom.microsoft.msedge.EMMXShareExtension
  2. https://www.fda.gov/media/144245/download
  3. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fhow-they-work.html
  4. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits/facts.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fvaccine-myths.html

COVID-19 Vaccine Safe…Skepticism High Among Americans

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Gallup polling shows about six in ten Americans are willing while four in ten Americans remain skeptical about taking a coronavirus vaccine

Polling has shown that there is lingering skepticism among Americans in taking the vaccines. Most cite the fact that the vaccine has been produced in months rather than the years it normally takes as the reason for the skepticism.

A Gallup poll released November 17, 2020, found Americans’ willingness to be vaccinated against COVID-19 rebounded. Fifty-eight percent (58%) of Americans in the latest poll say they would get a COVID-19 vaccine, up from a low of 50% in September while 42% of Americans would not agree to get a vaccine approved by the Food and Drug Administration. A plurality of the latter said the rushed timeline was a concern. Others cited a need to confirm it is safe or effective. Twelve percent said they generally don’t trust vaccines.

Globally, 61% of the world strongly agree with the statement, “vaccines are safe”, according to Gallup.

Unfounded fears about vaccine safety

“The process of the speed did not compromise, at all, safety, nor did it compromise scientific integrity,” Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said. “It was a reflection of the extraordinary scientific advances in these types of which allowed us to do things in months that actually took years before.”

Former Presidents Barack Obama, George W. Bush and Bill Clinton have all indicated that they will publicly take the coronavirus vaccine once approved and as soon as available to them, based on the priorities determined by public health officials in an effort to promote the vaccine’s use and safety.

Public health officials face an uphill climb in convincing a good share of the American public that the vaccine is safe and to receive the vaccination.

References:

  1. https://www.11alive.com/article/news/health/coronavirus/obama-coronavirus-vaccine/507-43ebe52f-3ad5-45e1-916f-1386f6eda819?utm_campaign=snd-autopilot
  2. https://news.gallup.com/poll/325208/americans-willing-covid-vaccine.aspx

Immune Response from COVID-19 Vaccine

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Experiencing an immune response was better than getting Covid-19

Many participants in Moderna and Pfizer’s coronavirus vaccine trials experienced an “immune response” such as high fever, body aches, bad headaches, daylong exhaustion and other symptoms after receiving the COVID-19 vaccine shots.

While the symptoms were uncomfortable for many, the participants said the symptoms went away after a day, sometimes sooner, and that “it was better than getting Covid-19”.

“We really need to make patients aware that this [COVID-19 vaccine] is not going to be a walk in the park,” Dr. Sandra Fryhofer of the American Medical Association said. “They are going to know they had a vaccine. They are probably not going to feel wonderful. But they’ve got to come back for that second dose.”

Both companies, Moderna and Pfizer, acknowledged that their vaccines could induce “immune response” — side effects — that are similar to symptoms associated with mild COVID-19, such as muscle pain, chills and headache.

It’s normal to feel under the weather or even somewhat ill—fatigued, achey, or experience a fever—after getting a vaccine shot. This results from the robust immune response as the body’s creating antibodies, actual protection against the coronavirus. It will happen to a percentage of the people who get the vaccine shot.

In other words, feeling like you’re in the early stages of getting the coronavirus is actually a sign that you’ll be protected from the actual virus. What you’re feeling is the body’s defense system gearing up.

Most vaccine shots mimic a virus entering your body. Immune cells, though, fire off chemical alarms as soon as they notice any virus-like particle. They activate the innate immune system, a generalized response that tries to make the body unlivable for any potential pathogen. That inflammatory reaction can cause a bit of a fever or a tiny swollen lump near the injection site.

The fatigue you might feel comes from gearing up a more specialized immune defense. Tiny, specialized cells called B-cells create antibodies, which are cellular fighter pilots specific to each virus. Making these antibodies requires expending a little extra energy at first, but the payoff is future protection: Once they’re present in your plasma, the antibodies can patrol for future viruses.

Additionally, it takes about two weeks for your body to whip its antibodies into shape; you could pick up a coronavirus in the window between getting your jab and when protection kicks in. That’s why it’s important to make sure you only get a coronavirus vaccine shot, or any vaccine, when you’re feeling healthy.

Not everyone will notice these symptoms after getting the vaccine shot. But if you do seem a bit off, the feeling shouldn’t stick around for more than a day or two, and shouldn’t require a visit to your healthcare provider.

References:

  1. https://www.cnbc.com/2020/11/23/covid-vaccine-cdc-should-warn-people-the-side-effects-from-shots-wont-be-walk-in-the-park-.html
  2. https://finance.yahoo.com/news/feeling-sick-getting-flu-shot-150519027.html

Vaccines Show Greater than Ninety Percent Efficacy

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“It’s not vaccines that save people; it’s vaccinations that will actually save people.” Edward Kelly, director of the WHO’s work on service delivery and safety

Biotechnology firm Moderna announced this week that preliminary results from large scale trials indicated that its coronavirus vaccine candidate demonstrated nearly 95 percent efficacy at preventing the illness.  This news comes on the heals of Pfizer’s announcement last week of it coronavirus vaccine candidate showed 95 percent efficacy (94 percent for adults over 65 years).

Efficacy refers to the performance of a treatment under ideal and controlled circumstances, and effectiveness is performance under real-world conditions. Clinical trials take place in a controlled environment to test if a vaccine is safe and if it works.

The efficacy rate means that COVID-19 symptoms were prevented for more than 90 percent for Pfizer’s coronavirus candidate and near 95 percent for Moderna’s candidate of participants who received the vaccine.

Pfizer plans to seek emergency use authorization for the vaccine, the company said.  This leave Pfizer’s vaccine on track to go into distribution by the end of the year if health regulators at the FDA permit.

Public health officials warn that the development of an effective COVID-19 vaccine represents the beginning of the challenge to vaccinate the world. “It’s not vaccines that save people; it’s vaccinations that will actually save people,” Edward Kelly, director of the WHO’s work on service delivery and safety, said.

A few of the significant challenges to vaccinate the world relate to vaccine supply, storage and distribution.  For example, Pfizer’s experimental vaccine requires ultracold storage conditions of about minus-70 degrees Celsius to ensure it remains effective.  While, Moderna’s vaccine can be kept at refrigerator temperatures for a month and frozen at minus-20 degrees Celsius for up to six months.

Additionally, there appears to be a steady reluctance among Americans and people across the globe to take the vaccine.  Convincing Americans that coronavirus vaccines are safe and effective will be another challenge thanks to the politicization of the vaccine development process by both sides of the aisle.

The U.S. Food and Drug Administration (FDA) will ultimately decide whether to authorize vaccines from Pfizer, Moderna and other candidates currently in large scale trials based on safety and effectiveness results that have been carefully reviewed by both government and independent health experts.

Health care workers should be given the highest priority to receive the vaccine and given to workers in essential industries, people with certain medical conditions, and people age 65 and older.

Bottom line, no vaccine is 100% effective, and whatever protection vaccines may provide, people should continue to wear masks, maintain social distancing, wash hands frequently, not touch their face and avoid crowded indoor gatherings until public health officials determine and the infection numbers demonstrate that the virus is under control.

References:

  1. https://www.washingtonpost.com/world/2020/11/16/who-vaccine-moderna-pfizer/
  2. https://www.wsj.com/articles/pfizers-covid-19-vaccine-95-effective-in-final-results-company-to-seek-approval-within-days-11605699996
  3. https://time.com/5907908/biden-administration-covid-19/?utm_source=twitter&utm_medium=social&utm_campaign=editorial&utm_term=health_covid-19&linkId=104044772

Sorrento Therapeutic’s COVID-19 Test

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Sorrento’s COVID-19 test appears to be superior to competing diagnostics, and it just made a good acquisition, while its overall strategy is sound.

Sorrento has produced a coronavirus test which is expected to be approved and then become widely used in the U.S. and potentially around the world.  The company requested emergency use authorization (EUA) from the Food and Drug Administration for its COVI-TRACK diagnostic test, which detects novel coronavirus antibodies. It also plans to file for an EUA for COVI-TRACE, a rapid salivary diagnostic test licensed from Columbia University.

Sorrento has been even more active in developing potential treatments for COVID-19. The biotech filed for FDA approval earlier this month to begin a phase 1 study of antibody therapy STI-1499 (COVI-GUARD) in treating hospitalized COVID-19 patients. It hopes to quickly advance the candidate through clinical testing and perhaps even receive an EUA for STI-1499 as soon as the end of 2020.

a number of test tubes and capsules are pictured under a cool blue light

Source: Shutterstock

Sorrento’s coronavirus test yields results in just 30 minutes, does not require lab equipment and doesn’t have to be sent to labs. As a result, it, unlike other tests, could be used by hospitals, stadiums, hotels, office buildings and other organizations to allow people to safely enter their facilities on the same day that the test is taken.

References:

  1. https://investorplace.com/2020/08/sorrentos-covid-19-test-acquisitions-should-help-srne-stock-surge/
  2. https://www.fool.com/investing/2020/08/24/why-sorrento-therapeutics-stock-is-sinking-today/

How Vaccines Work, How They’re Developed and What’s the Latest on One for COVID-19

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By Andrea Klemes, DO, FACE, CMO MDVIP

Since the coronavirus pandemic began in early 2020, we’ve heard a lot about vaccines. There have been promises for quick vaccine development as well as warnings about how long it really takes to develop a safe, effective vaccine.

You’ve also probably heard that a coronavirus vaccine is necessary for us to return to normal. The good news? Surprising progress has been made in creating vaccines for COVID-19. As of now, there are more than 160 vaccines in various stages of development, and many are already into the human testing phase. While the path to success is still uncertain, never in human history have so many scientists and resources been devoted to a single public health crisis.

In July, multiple vaccine manufacturers released preliminary data from phase 1 studies that showed new vaccines are well tolerated and created antibodies. This is good news because it shows success in human subjects; in phase 1 trials, small groups of people receive the vaccine. Three vaccines are either currently in a later phase of development, where they are being tested on thousands of people, or about to enter that phase.

While it’s good news, there’s a long way to go. Here’s a quick primer on how vaccines work, how they’re developed and where we stand developing a vaccine for the current coronavirus outbreak.

How Vaccines Work
Vaccines work by mimicking a virus or bacteria that enters the immune system to build up antibodies. Ironically, vaccines are one of our oldest modern medical treatments. The first effective vaccination — to smallpox — was developed in the late 18th century. Over the last 220 years, scientists have advanced the process and effectiveness for vaccines.

Modern vaccines are simple in concept: create a synthetic compound that behaves like a real live pathogen that doesn’t cause illness. The compound will instead provoke the immune system to create antibodies that teach the body to react quickly and forcefully if the real pathogen invades the body.

Antibodies are an essential part of your immune system. When a pathogen, like bacteria or a virus, invades your body, antibodies bind to the invader and neutralize it, minimizing its damage. Your body came with some antibodies, which were passed from your mother. But most antibodies are developed over time when you’re exposed to pathogens. Vaccines make that natural process happen without infecting you with a real virus or bacteria.

How Vaccines Are Made
There are four basic types of vaccines, but regardless of the type, the process to produce safe and effective vaccines is typically long and difficult. When we’re not in crisis mode, vaccine labs can take anywhere from 10 to 15 years to develop a new vaccine. Of course, when we’re in the throes of a pandemic, labs generally move quicker. For example, during the mumps outbreak, a vaccine was generated in four years – the quickest in U.S. history.

Labs are currently working on an even faster timetable, with hopes that a COVID-19 vaccine might be available by the end of 2020 or by the middle of next year.

The reason it takes so long it that there are five phases of vaccine development:

  • Exploration: In this stage, drug companies investigate different approaches to the vaccine. Historically, this phase lasts between two and four years; however, evolving technology has help quicken the pace of this phase for some vaccines, including COVID-19. Another factor that has helped speed up the exploratory stage of the COVID-19 vaccine is information sharing among scientists; for example, scientists genetically mapped the virus as early as January — something that would have taken much longer 10 or 20 years ago. Also, since COVID-19 is similar to SARS — another coronavirus that caused a six-month pandemic in 2003 — scientists working on the COVID-19 vaccine were able to learn from those working on the SARS vaccine — a significant head start.
  • Preclinical: Once researchers develop a vaccine candidate, it’s tested in cell cultures and animals to see if it triggers an immune response without damaging cells. This takes about a year. And if the vaccine doesn’t work, researchers circle back to the exploration phase. But if it is successful, it moves on the testing phase.
  • Testing: Vaccines are tested through clinical trials – research studies that evaluate the effectiveness and safety of vaccines, medications, medical devices, surgical procedures or behavioral interventions on a group of people. Most trials start with a small group of people (phase 1), and, if they go well, they are expanded to include a moderate size group of people (phase 2) and then a large group (phase 3). Of course, if issues arise during clinical trials, the vaccine reverts to the preclinical phase.
  • Regulatory review: If clinical trials go well, the drug company submits a Biologics License Application and product label for the vaccine. In the United States, applications and labels are sent to the U.S. Food and Drug Administration (FDA). In the U.S., this process takes about 10 months, although in a circumstance such as the COVID-19 pandemic, the process will probably be accelerated.
  • Production: Once the drug manufacturers have been given a green light, they can begin producing the vaccine. In the U.S., the FDA continues overseeing the production of the vaccine.


Where COVID-19 Vaccines Stand
At the end of July there were 23 vaccines in clinical testing and another 137 in pre-clinical development, according to the World Health Organization.

Dr. Erica Saphire, an infectious disease authority and professor at La Jolla Institute for Immunology, recently told medical officials that the earliest a vaccine may be available is January 2021, but it’s more likely that a viable vaccine won’t be available until July 2021 or later. Even when one is available, it will take time to get the vaccine manufactured and distributed. Of course, once a vaccine is available, healthcare workers, first responders and those at the highest risk – nursing home patients, for example — will probably be the first to have access to the vaccine.

Until a vaccine is available, continue to take precautions such as wearing a face mask and social distancing to lower your risk of contracting COVID-19. And continue working closely with your physician to help you control chronic conditions and maintain a strong immune system that can lower your chances of developing serious complications should you catch COVID-19.

USG Ordered 100M Doses of Experimental Covid-19 Vaccine | Barron’s

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U.S. Government has ordered from Pfizer and BioNTech 100M Doses of Experimental Covid-19 Vaccine.

The U.S. government has put in an order for enough doses of Pfizer and BioNTech experimental Covid-19 vaccine to inoculate nearly every American.

Pfizer and BioNTech said that the companies are selling 100 million doses of the vaccine to the U.S. Department of Health and Human Services and the Department of Defense for $1.95 billion, a deal that prices each dose of the experimental vaccine at $19.50.

The deal allows the U.S. government the option of buying an additional 500 million doses.

Americans would receive the vaccine free, according to the companies. Pfizer and BioNTech would provide the doses after the vaccine receives approval or emergency authorization from the Food and Drug Administration, and the government will make the payment after the first 100 million doses are delivered.

Read more: https://www.barrons.com/articles/pfizer-covid-19-vaccine-price-government-deal-51595425522?mod=bol-social-fb

Pfizer and BioNTech announced that two of the companies’ investigational COVID-19 vaccine candidates have received “Fast Track” designation from the U.S. Food and Drug Administration (FDA). Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need.