North Atlanta Primary Care

COVID-19 Update Article

Coronavirus Update #13

Posted on June 02, 2020 by Physicians and Staff at NAPC

COVID-19 Vaccine Development

It has been over 2 weeks since NAPC has communicated what is new in Coronavirus treatments and care. Georgia has expanded COVID-19 testing and NAPC has educated our patients about the differences between serologic and diagnostic testing for SARS-CoV-2. We have shared with you the necessity of social distancing, home hygiene, self-isolation and quarantine, COVID care plans, and best use of virtual telemedicine visits. We have succeeded in maintaining all of our medical clinics open and continued to provide essential care to ALL of our NAPC patients. We continue to keep our staff and our patients’ safe as we deliver high quality care to you. NAPC is proud to be the leader in providing award winning ambulatory primary care to our communities. We remain the GOLD standard for healthcare in Georgia.

Today we will discuss the development of a coronavirus vaccine. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said that we are likely 12-18 months away from a vaccine. In general most vaccines take 10-20 years to develop. However, ten coronavirus vaccines are already in human trials. Over 100 vaccines are in preclinical stage and many will proceed to human trials in the near future. This should give us all great hope that the US will lead the world in controlling COVID-19 in the very near future.

What is a vaccine?

A vaccine helps prevent a disease or reduce the risk of infection. It works with your body’s natural defense system to build immunity. According to the CDC a vaccine contains ingredients that imitate an infection in your body. It could be a weakened or dead virus or bacterial, or parts of the genetic code in a virus or bacteria. Though vaccines can cause side effects, they do not make you sick with the illness you are vaccinating against. But they do cause your body to produce immune cells called macrophages, T-lymphocytes, and B-lymphocytes to fight off the disease.

After getting a vaccine, it takes your body time to build up protection. If you are exposed to the actual virus or bacteria in the future, your body remembers how to fight it. Some vaccines are good for life while others may require a booster shot. Vaccines for influenza are updated annually as the flu has many subtypes and changes that require fine tuning.

What are the steps for developing a vaccine?

As the world continues to feel the impact of COVID-19, the biopharmaceutical industry is working 24/7 to identify and develop safe and effective vaccines. It usually takes 10-20 years to develop a successful vaccine, so why so long? Vaccines go through a multistage research process that includes several rounds of testing. The stages are meant to ensure that the vaccine works and is safe.

Step 1: Identify and Sequence the Virus.

On January 10, 2020, Chinese health officials released the full genetic sequence of the novel coronavirus that can cause COVID-19. Researchers around the world started immediately to work on a vaccine. Compared to previous pathogens this alone is a remarkable accomplishment, and will dramatically shorten the time to achieve a goal of having a reliable, safe and effective product.

Step 2: Determine the Target.

Vaccines work by imitating an infection to teach the immune system how to recognize, remember and target microbial invaders, like viruses and bacteria, without actually causing an infection. The process to determine how to best deliver a vaccine is complex as different approaches may work better for different pathogens. Historically, some vaccines, such as the measles vaccine, have used live but weakened versions of a pathogen, while others have used viral material that has been chemically inactivated or killed, which is the method used by the polio vaccine.

Newer vaccines, such as the vaccine for hepatitis B, contain only a small part of a pathogen—usually a specific protein that the body can learn to recognize, known as an “antigen.” Given the pressing need for a safe and effective vaccine for the novel coronavirus, along with the volume of information that remains unknown about the disease, a wide range of approaches to vaccine development are being tested by biopharmaceutical researchers throughout the world to greatly improve the odds that one or more of these approaches will be successful.

Step 3: Conduct Preclinical Trials.

The potential vaccine is first tested in cell cultures then in animals. These tests help researchers determine if a vaccine creates an immune response. Researchers may even vaccinate animals and then try to infect them with the disease. This is a challenge trial and can yield data that may shorten development of a vaccine dramatically. However, many vaccines do not make it past this stage because they do not illicit an immune response. As of May 22, 2020 over 107 vaccine candidates have entered preclinical testing.

Step 4: Conduct Clinical Trials.

If the vaccine makes it through the preclinical stage, the manufacturer will submit an application for an Investigational New Drug (IND) to the FDA. The application includes information on the vaccine’s testing and manufacturing, and how the manufacturer intends to test the vaccine going forward. If the FDA approves the application, the drug moves to three phases of clinical testing on humans.

  • Phase I clinical trial: The vaccine is tested on 20 to 100 healthy adults to see how it works. This phase usually takes several months. About 70% of drugs move to the next phase.
  • Phase II clinical trial: The vaccine is tested on a larger group of subjects — up to several hundred people. Some of these people may be at risk of getting the disease. The vaccine’s safety, immune response, proper dose, dose schedule, and method of delivery are evaluated. This phase can take several months to 2 years. About 33% of drugs that make it to phase II trials move to the next phase.
  • Phase III clinical trial: The vaccine is tested on 300 to 3,000 people or more to determine how safe the vaccine is amongst a large group of people. This phase can take 1 to 4 years. About 25% to 30% of drugs that make it to phase III trials move to the next stage.

Step 5: Obtain Regulatory Approval.

If phase III trial is successful, the manufacturer will submit a Biologics License Application to the FDA. The FDA evaluates the clinical trial data for the vaccine to see if it is safe and effective in preventing infection. They also inspect the facility where the vaccine is made and make the decision to approve it.

Step 6: Manufacturing and Distribution.

While the vaccine is going through clinical studies, biopharmaceutical researchers are also developing the manufacturing methods that will be used if the new vaccine is successful. For some types of vaccines used in large populations, these methods then undergo massive scale up to enable the manufacture of what can be many millions of doses. This is an enormous undertaking, as the transition from laboratory to manufacturing facility is incredibly complex and must ensure consistency in the vaccine composition and safety and efficacy profiles. As developing the manufacturing strategy can be a multi-year process, biopharmaceutical companies are already seeking to expand their manufacturing capacity. Companies are also initiating manufacturing capabilities at risk, well before a COVID-19 vaccine receives regulatory approval, to speed the production process when a vaccine is ready.

Safely delivering a vaccine to patients around the world is an equally challenging undertaking, especially in less developed regions, as vaccines often require special handling, such as temperature control, during distribution. Biopharmaceutical companies are working closely with local governments and NGO partners to lay the groundwork for potential distribution at global scale.

What COVID vaccines are currently in development?

Institutions

Country

Type of Vaccine

Status

Beijing Inst. of Bio-technology

China

Non-replicating
Viral vector

Phases 1 and II

Moderna and NIH

USA

mRNA

Phases I and II

Inovio Pharma

USA

mDNA

Phase I

Beijing Inst. And Sinopharm

China

Inactivated virus

Phases I and II

Wuhan Inst. And Sinopharm

China

Inactivated virus

Phases I and II

Sinovac

China

Inactivated virus

Phases I and II

Univ. of Oxford and AstraZeneca

UK

Non-replicating viral vector

Phases I and II

BioNTech and Pfizer

USA/Europe

mRNA

Phases I and II

Inst. Of Medical Biology and Chinese Academy of Medical Sciences

China

Inactivated virus

Phase I

Novavax

USA

Protein subunit

Phases I and II

 

 

What can you do to be prepared for upcoming therapeutics and vaccines?

  • Remain vigilant in your work, home and social environment.
  • Continue to practice social distancing, wear a face mask, and wash your hands.
  • Educate your family and friends about infection control and COVID.
  • Plan on receiving a 2020/2021 Influenza vaccine when it is available in September.
  • Talk with your doctor about receiving the pneumonia vaccine if you are above 65.
  • Talk with your friends and family about why vaccines are important in protecting society. Vaccine education is tremendously important today.
  • Keep your medical appointments. Stay on your medications.
  • If you are experiencing stress, anxiety or depression, please let your doctor help.
  • If you are developing COVID symptoms, self-isolate and call your doctor for testing.
  • Make a COVID care plan with your doctor.

In Summary:

The biotechnology industry is moving at record speed in developing vaccines with new technology. The entire world is in this battle together as too many individuals have suffered greatly. The news media is distracted frequently about how best to present a nightly news show and commentary. The work of The National Institute of Allergy and Infectious Diseases (NIAID), the US Dept. of Defense, the Coalition for Epidemic Preparedness Innovations and the Bill and Melinda Gates Foundation are all cooperating in making strides to achieve a coronavirus vaccine by years end. With the expertise of biopharmaceutical firms worldwide America will succeed in this critical endeavor.

Thank you for your trust in allowing NAPC to provide healthcare during this period of uncertainty and national emergency. Your healthcare is our number one priority. NAPC has grown and succeeded over 30 years and continues to lead in providing the best quality healthcare for our communities. We have faced numerous challenges and NAPC is committed to providing all our patients the best experience as we move forward and conquer coronavirus.  Please stay safe and stay home.

#NAPCSTRONG.

Respectfully,

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