Romano Law Nurse Corner #13 - Status of COVID-19 Vaccines

Serving nearby areas by Palm Beach and West Palm Beach, Florida

Romano Law Nurse Corner #13

Status of COVID-19 Vaccines

 

Recent reports reveal there are currently about 6.9 million worldwide confirmed COVID-19 cases, and  the United States has reported about 1.9 million COVID 19 cases.  Most everyone agrees that our scientific efforts need to be geared towards not only the availability of a treatment to slow the pandemic and lessen the disease’s damage, but also in developing a safe and effective vaccine to protect humans against this terrible virus.  By now, most understand that COVID-19 is not going away.   Scientists across the globe are working tirelessly to understand the virus at a molecular level to help this effort. 

Coronaviruses have a spike type of structure on their surface called an S protein.  This S protein gives it the crown-like appearance for which they are named, “corona”, meaning crown.  This S protein attaches to the surface of human cells and reproduces causing illness.   Scientific efforts to develop a vaccine that targets this protein would prevent it from binding to human cells and reproducing.  However, developing a vaccine to COVID-19 and similar viruses includes several different approaches. 

Live Vaccines

Live vaccines use a weakened or attenuated version of the actual virus.  This type of vaccine causes the immune response without causing the disease because the attenuated version of the virus does not have the ability to actually cause disease.  Currently live vaccines are used to protect against measles, mumps, rubella, smallpox and chickenpox.  This is the most widespread way that we have developed vaccines historically.  Live virus vaccines often need extensive safety testing and can be a problem for people with weakened immune systems.

Inactivated vaccines

Inactivated vaccines use a killed or inactive form of the virus.  This kind of vaccine causes an immune response without infection.  Currently, these types of vaccines are used to prevent the flu, hepatitis A and rabies.  These inactivated vaccines might not produce as strong of a response and protection that is produced by live viruses.  They also usually require multiple doses followed by booster doses for long-term immunity.  Also notable is the fact that producing these vaccines require handling of large amounts of infectious virus.

Genetically engineered vaccines

These use genetically engineered RNA or DNA (genetic material) that contain instructions for the cells to make copies of the S protein.  These copies prompt an immune response to the virus.  No infectious virus needs to be handled, however so far, none of these genetically engineered vaccines have been licensed for human use.

Many believe that developing a vaccine for large scale distribution before the end of 2020 or 2021 would be almost impossible, yet there is some hope.  In recent years, we have seen scientists respond urgently to epidemics of H1N1 influenza, Ebola, Zika.  For H1N1 influenza, a vaccine was developed rapidly because influenza technology was well developed and ultimately incorporated into commercially available seasonal influenza vaccines. 

However, the rapid development of vaccines for SARS, Ebola and Zika slowed dramatically once the epidemics ended, which was before vaccine development was complete.  A part of the reason for this is that once the epidemic and its large scale devastating effects ended, federal funds that had been committed to those particular vaccine development efforts were re-allocated.  This loss of financial support set back many of the vaccine development programs. However, the need for rapid development and the methods of research have steadily improved and continue to be necessary. Clearly, as we live in the new COVID-19 world, a vaccine is essential.

Currently, there are TEN (10) COVID-19 vaccine candidates in clinical evaluation and 114 candidates in preclinical evaluation. The rapid development of these advanced vaccine candidates make use of some of the above-mentioned newly emerging scientific technology platforms (see below for chart).

For example, Moderna’s nucleotide-based vaccines use a synthetic lipid nanoparticle to carry the genetic sequence into the host cells for those cells to express antigens and build immunity. 

In a collaboration between the University of Oxford and AstraZeneca, a chimpanzee adenovirus is engineered to carry DNA for the S protein antigen. Adenoviruses are naturally immunologic which helps the body generate a more significant immunological response.  

The U.S. Federal Government has taken this urgent need for a worldwide vaccine to implement Operation Warp Speed, which is supposed to deliver a COVID-19 vaccine faster than any previous vaccine.  On May 21, 2020 in a press release, Warp Speed announced an investment of 1.2 billion to AstraZeneca for the vaccine (mentioned above) that is currently being developed by researchers at the University of Oxford’s Jenner Institute, noting that the delivery of the first of at least 300 million doses should arrive in October. Other manufacturers are also committed to developing a vaccine. 

However, concerns arise with many researchers, including William Haseltine, a former Harvard University HIV/AIDS researcher who helped launch several prominent biotechnology companies, opining that he doubts this vaccine has any advantage over other approaches

Recently, Maryland based biotech company Novavax expanded its manufacturing capacity for its COVID-19 vaccine candidate by acquiring a manufacturer in the Czech Republic for $167 million.  This should provide an annual capacity of more than 1 billion doses of antigen for their vaccine candidate starting in 2021.  Further, Novavax began enrolling its first human participants in a phase 1 of 2 of a clinical trial.  Preliminary immunogenicity (ability to provoke an immune response) and safety results from the Phase 1 portion of the trial are expected in July 2020.

Last week, U.S. Company Merck joined the COVID-19 battle with its 3 initiatives to help end the pandemic.  Merck bought Vienna based company Themis Bioscience, which is in the midst of developing a vaccine working in collaboration with several non-profits (IAVI AND Ridgeback Bio) on a vaccine and antiviral candidate.

In May, Sorrento Therapeutics, a smaller biotech company announced that it has an antibody drug that has been effective in early testing to block the virus that causes COVID-19.  They are hopeful that this medication might be effective to help treat people as well as help prevent infection.

While there is much research underway for a vaccine for COVID-19.  The need is so great.  So much is unknown about when and if a successful vaccine will be fully developed and ready for use.   Once that vaccine does exist, the next challenge will be seen with distribution, delivery and administration. General access needs to be universal despite any geographic or commercial factors involved.   At this point in time, it is clear that we need COVID-19 vaccines available globally, however that is achieved. 

TableCOVID-19 vaccines in clinical trials

 

Developer

Properties

Development status

mRNA-1273

Moderna and NIAID

mRNA vaccine

Phase 2

BNT162

BioNTech and Pfizer

mRNA vaccine

Phase 1/2

INO-4800

Inovio Pharmaceuticals

DNA vaccine

Phase 1

AZD1222

University of Oxford and AstraZeneca

Adenovirus vaccine

Phase 2b/3

Ad5-nCoV

CanSino Biologics

Adenovirus vaccine

Phase 2

Unnamed

Wuhan Institute of Biological Products and Sinopharm

Inactivated virus

Phase 1/2

Unnamed

Beijing Institute of Biological Products and Sinopharm

Inactivated virus

Phase 1/2

PiCoVacc

Sinovac

Inactivated virus, plus adjuvant

Phase 1/2

Unnamed

Institute of Medical Biology and Chinese Academy of Medical Sciences

Inactivated virus

Phase 1

NVX-CoV2373

Novavax

Protein subunit

Phase 1/2

 

Sources:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31252-6/fulltext

https://www.healthline.com/health-news/heres-exactly-where-were-at-with-vaccines-and-treatments-for-covid-19

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/accelerating-a-safe-and-effective-covid-19-vaccine

https://www.investopedia.com/novavax-and-merck-fuel-covid-19-vaccine-hopes-4845931

https://www.nejm.org/doi/full/10.1056/NEJMp2005630

https://www.sciencemag.org/news/2020/05/doubts-greet-12-billion-bet-united-states-coronavirus-vaccine-october

https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-vaccine/art-20484859

 

We are Susan Ramsey and Amie Goldberg, both practicing attorneys and nurses here at the Romano Law Group.  Here is a little more about each of us:

Susan

Susan Ramsey is both an attorney and an RN. Ms. Ramsey’s professional experience began as a Registered Nurse in the Intensive Care Unit at Yale New Haven Hospital. While pursuing her Bachelor’s Degree, she was a counselor with the New Haven Rape Crisis Program. During her time with the Program, Ms. Ramsey counseled sexual assault survivors and performed seminars for local police departments, universities, and high schools. During her time working as a registered nurse, Ms. Ramsey decided to attend law school. Ms. Ramsey graduated from CUNY Law School, and has practiced law in several different State and Federal Courts.  She is a Florida Heath Care Risk Manager and a member of the Palm Beach County Sober Home Task Force.  Ms. Ramsey actively litigates cases involving catastrophic injuries and wrongful death on behalf of survivors, cases include injuries suffered by victims of professional negligence, product liability and medical negligence.

Amie 

Amie Goldberg is both an attorney and a certified APRN.  After completing a Bachelor of Arts Degree at Whittier College, Ms. Goldberg attended nursing school at Emory University.  Ms. Goldberg’s professional experience started as a Registered Nurse at Egleston Children’s Hospital taking care of children with congenital heart disease. After a few years, she continued working in all areas of the hospital while attending Kennesaw State University on weekends in order to get her Master’s Degree in Nursing with a specialty of Primary Care Nurse Practitioner/Family Nurse Practitioner.  During her time as an APRN, Ms. Goldberg decided to attend law school at St. Thomas University in Miami, Florida.   Since graduating, she has mainly practiced in the areas of personal injury and worker’s compensation, fighting for the rights of injured people. Since joining the Romano Law Group, Ms. Goldberg has been the Director of the Opioid Litigation Project.  Ms. Goldberg also practices in the area of medical malpractice and nursing home negligence, bringing an inside perspective and knowledge to help get justice for our clients. 

 

Stay Safe,

Susan

Amie