Category Archives: @Coronavirus, @COVID-19

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.

COVID-19 vs. 1918 Spanish Influenza Pandemic | The Daily Social Distancing Show with Trevor Noah

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One of the lessons experts learned from the 1918 flu pandemic is how quickly the pandemic was forgotten and how fast it disappeared from the political discourse.

The one lesson learned from a pandemic should be to never forget because forgetting doesn’t lead to positive public health outcomes.

There has been several global public health emergencies since 1918 such as SARS in 2003 and the 2009 H1N1pandemic influenza. Yet, these events have caught authorities and the general public by surprise, but not the epidemiologist who have been studying pandemics were not surprised.

Another lesson to remember is that governments have the responsibility to prepare for a pandemic; they have the obligation to invest in public-health systems to protect their citizens from both the threat and the reality of the next pandemic.

References:

  1. https://news.harvard.edu/gazette/story/2020/05/harvard-expert-compares-1918-flu-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.

COVID-19 Precautions

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Health experts continue to urge Americans to take precautions against spreading and contracting coronavirus disease 2019 (COVID-19) more seriously.

As of July 20, 2020, more than 3,784,900 people in the United States have been infected with the coronavirus and at least 140,300 have died, according to a New York Times (#NYT) database.

As COVID-19 infection numbers are surging throughout most of the United States, everyone, especially older adults over the age of 65 and others with pre-existing conditions, should take steps to protect themselves from getting and spreading COVID-19. In general, your risk of getting severely ill from COVID-19 increases as you get older. In fact, 8 out of 10 COVID-19-related deaths reported in the United States have been among adults aged 65 years and older.

Since there is currently no vaccine to prevent COVID-19, the best and most effective way to prevent contracting the illness is to avoid being exposed to this virus. There are more than 160 vaccines being researched, developed and tested against the coronavirus, and 26 vaccines are in human trials. Four (4) potential vaccines are currently in large scale phase III efficacy trials according to the New York Times.

Everyone is at risk for getting COVID-19 if they are exposed to the virus. The virus spreads primarily through respiratory droplets produced when an infected person coughs, sneezes or talks. These droplets can land in the mouths, noses or eyes of people who are in close contact with one another (within about 6 feet).

Recent studies have shown that #COVID-19 can spread by people who are asymptomatic (not showing symptoms). To arrest the community spread of COVID-19, you should:

  • Wear a cloth face mask to cover your mouth and nose in public settings and when around people who don’t live in your household.
  • Keep 6 feet (2 meters) of distance between yourself and people who don’t live in your household. It’s important to remember that infected people without symptoms are able to spread virus.
  • Avoid touching your face, specifically your mouth, nose or eyes.
  • Wash your hands often with soap and water for at least 20 seconds especially after you have been in a public place, or after blowing your nose, coughing, or sneezing.
  • Prioritize outdoor venues over indoor spaces if you must go out,
  • Clean and disinfect frequently touched surfaces daily.
  • Monitor your health daily and be alert for COVID-19 symptoms such as fever, cough, shortness of breath, fatigue, headache, or loss of smell.

How well a community as a whole does all of that could dictate how bad things get during the current resurgence.

References:

  1. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html
  2. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html
  3. https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

EPA Approves Lysol as Effective Against the Novel Coronavirus

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The Environmental Protection Agency (EPA) has found Lysol Disinfectant Spray and Lysol Disinfectant Max Cover Mist to be effective against the coronavirus. The Lysol products are permitted by the EPA to claim that they can kill SARS-CoV-2, the virus that causes COVID-19.  Lysol Disinfectant Spray and Lysol Disinfectant Max Cover Mist are the first two surface disinfectant products the EPA has approved as effective against the novel coronavirus.

Lysol Disinfectant Spray can kill the virus “at 2 minutes of use,” per the release. This product was found to be more than 99.9% effective against the virus. The spray can be used throughout your home, on hard and soft surfaces.

The EPA’s approval recognizes that using Lysol Disinfectant Spray can help to prevent the spread of COVID-19 on hard, non-porous surfaces.

The two Lysol products are the first on the list for which the EPA has reviewed laboratory testing data and approved label claims against the novel coronavirus. In addition to the novel coronavirus, Lysol Disinfectant Sprays can kill 99.9% of the viruses and bacteria that families generally come in contact with every day. The disinfectants can be used to eliminate germs on commonly touched hard and soft surfaces.

References:

  1. https://www.today.com/health/two-lysol-sprays-first-disinfectants-proven-work-against-covid-19-t186106
  2. https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2-covid-19
  3. https://www.lysol.com/products/disinfectant-spray/lysol-disinfectant-spray-lemon-breeze/

Wearing Masks Prevents COVID-19 Spread

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Face masks can play an important role in preventing the spread of the coronavirus from infected persons respiratory systems. Masks form a literal barrier to stop particles from getting into the air and spreading to others.

Scientist Bill Nye “The Science Guy” is urging everyone to wear a mask in the fight to stop the spread of the coronavirus.  He states that the mask is extremely effective at preventing “particles from your respiratory system from getting into my respiratory system” and vice versa.

https://www.youtube.com/watch?v=ZYKWjhixSHk&app=desktop

The Centers for Disease Control and Prevention (CDC) has recommended everyone wear a (cloth) mask to prevent infected people passing on the infection. It is not intended to prevent the wearer getting infected.

There are several possible routes to infection:

  • An infected person can cough, sneeze or breathe while within about two metres of another person, and the virus lands in the other person’s eyes, nose or mouth.
  • Another route is when an infected person coughs or sneezes onto their hand or onto a surface. The uninfected person then shakes the hand or touches the surface, and transfers the virus to their own eye, nose or mouth.
  • It is possible that an infected person can also cough or sneeze to create an airborne spread beyond the close contact range – but it is controversial whether this last route is a major means of transmission.

Masks with eye protection appear to work best because coronaviruses can enter the eyes and travel to the nose and into the respiratory system.  Thus, masks combined with goggles appear to provide complete protection in laboratory experiments.

Masks protect effectively others from the virus that might have been spread by an infected mask wearer and may prevent the spread of viruses from the wearer.

Masks reduce the amounts of droplets and aerosols spread when an infected person coughs or sneeze.  Ill people who don’t wear a mask and “well” people who have no symptoms but are still carrying and spreading the virus are the reasons people should wear masks while in public.

Wearing Masks

Wearing masks does appear to reduce the spread of the infection to others.  Everyone with any respiratory symptoms must wear masks in public. This requirement could supplement other strategies such as social distancing, testing, tracking and tracing to reduce transmission.

To capture infected people without symptoms, we could ask everyone to wear masks in public spaces. Masks could also be required at some outdoor crowd events, such as sporting events or concerts.

Many medical experts know that the best practices for controlling an infectious disease like COVID-19 include keeping six feet apart from others, washing your hands regularly, and, wearing face masks in public.

  1. https://news.yahoo.com/bill-nye-demonstrate-face-masks-184448520.html
  2. https://www.sciencealert.com/this-is-why-advice-on-whether-you-should-wear-a-mask-is-just-so-confusing

Goldman Sachs’ Analysis Shows Economic Benefits of Wearing Masks

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“The fate of many lives, not to mention the U.S. and global economy, largely depends on the containment of the novel COVID-19 coronavirus.” Goldman Sachs

  • Cloth face coverings may help prevent people who have COVID-19 from spreading the virus to others.(2)
  • Cloth face coverings are most likely to reduce the spread of COVID-19 when they are widely used by people in public settings.(2)

According to a recent analysis by U.S. investment bank, Goldman Sachs, there’s one simple thing Americans can do that would boost U.S. GDP and make a huge difference to the economy, American jobs, and overall prosperity.

Illustration of people wearing cloth face masks

Goldman Sachs’ analysis, led by its chief economist Jan Hatzius, concluded that “a universal mask-wearing order can improve the U.S. GDP by a huge five percentage points”.  And according to Centers for Disease Control and Prevention (CDC), “cloth face coverings are recommended as a simple barrier to help prevent respiratory droplets from traveling into the air and onto other people when the person wearing the cloth face covering coughs, sneezes, talks, or raises their voice”.

Goldman agrees with the emerging scientific evidence that “face masks are associated with significantly better coronavirus outcomes.”  And, based on the growing evidence, the Centers for Disease Control and Prevention has expanded its mask guidance stating that Americans should wear them in all “public settings and when around people who don’t live in your household, especially when other social distancing measures are difficult to maintain”.

Goldman’s analysis concludes “a national face mask order could increase face mask-wearing by 15 percentage points, reducing the transmission growth rate of confirmed cases from 1.6% to 0.6%”. Goldman concludes that “increased face-masking would substitute for local lock downs and social distancing, which caused U.S. GDP to decline 17% between January and April”.

While anecdotal evidence does suggest strongly that universal mask-wearing can greatly benefit the economy and save lives, it has been difficult to convince Americans of this fact.  As a result of not mandating a national face mask-wearing, there has been a resurgence of COVID-19 inflections and hospitalizations in a number of southern and western states in the U.S.

From a medical expert perspective, “if everyone in the U.S. wore a mask, the coronavirus pandemic could be under control within four to eight weeks”, was conveyed by Centers for the Disease Control and Prevention director Robert Redfield in a discussion led by medical journal JAMA.

In summary, Goldman Sachs’ analysis suggests that the economic benefit from “adopting a national face mask mandate and increased face mask usage” could be sizable, especially when compared with the alternative of a return to broader societal lock downs and increasing COVID-19 infections.

Sources:

  1. https://www.nasdaq.com/articles/goldman-sachs-says-this-simple-measure-can-save-lives-and-the-economy-2020-07-14
  2. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/diy-cloth-face-coverings.html
  3. https://www.goldmansachs.com/insights/pages/face-masks-and-gdp.html
  4. https://apple.news/ApjIDbf3mR_u11IZp8goONw

FDA Fast Tracks Two COVID-19 Vaccine Candidates

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Positive early data shows the vaccines spur the generation of more neutralizing antibodies

The U.S. Food and Drug Administration (FDA) has granted “fast track” status to two promising coronavirus candidates from Pfizer and BioNTech. The two vaccine candidates are called BNT162b1 and BNT162b2, and both are messenger ribonucleic acid (or mRNA) vaccines.

The fast-track status was granted based on preliminary data from phase one and two studies in the U.S. and Germany. The company expects to enroll 30,000 people in its next phase of trials.

If the trials are successful, the companies hope to make 100 million doses by the end of the year and possibly more than 1.2 billion doses by the end of 2021.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” said Peter Honig, senior vice president of global regulatory affairs at Pfizer.

References:

  1. https://www.consumeraffairs.com/news/fda-fast-tracks-two-new-vaccine-candidates-071320.html
  2. https://www.thestreet.com/investing/pfizer-up-on-fda-fast-track-status-for-coronavirus-vaccine

Young Adults Driving New Cases of COVID-19| USAToday

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People under 40 now make up the majority of COVID-19 cases, according to a USA TODAY analysis of data from 17 states.  They found that the average age of a new person reported to have coronavirus has fallen significantly since March.

Although younger adults are less likely to develop severe infections of COVID-19, some do develop serious and even life-threatening complications.

Read more:  https://www.usatoday.com/in-depth/news/2020/07/07/younger-people-driving-new-cases-covid-19-putting-elderly-risk-cases-deaths/3285566001/?fbclid=IwAR17Db8MyyCviXun8o557bC1QKt2dpa53ewkUYX8TiFDMjL_MU7H6FqU5O8