Covid-19 Vaccines

The latest Covid-19 vaccinations and treatment candidates – Part 2

Since the first case of SARS-Cov-2 was identified in Wuhan, China as the cause of a respiratory outbreak, our journey to discover a treatment began. Although the origin of SARS-CoV-2 resulting in the Covid-19 virus remains unclear, the pursuit to produce vaccination and other treatment alternatives is rapidly underway.

As our understanding of the novel Covid-19 virus advances, so has our knowledge of vaccinations. Typically transmitting person to person through respiratory droplets, this virus is known to cause symptoms of fever, cough, and shortness of breath. The resulting clinical outcomes can range from as mild as asymptomatic to as severe as fatal.

Vaccination and Treatment Options

Our understanding of Covid-19 vaccinations and treatment outcomes is quite limited at this time. Although only a few vaccines have been approved by the FDA by Pfizer and Moderna, there are several other promising candidates on the horizon. From innovative DNA-based and intranasal vaccines to antibody and other drug treatments, the majority are either in their preclinical or early clinical stages of testing.

Let’s take a closer look at some of the latest Covid-19 vaccine and treatment prospects in terms of safety, efficacy, administration, and more.

1.  INOVIO Pharmaceuticals — INO-4800

Inovio Pharmaceuticals has worked diligently in developing and testing a vaccine candidate known as INO-4800 in a Phase 1 clinical trial.

What is this vaccine?

INO-4800 is a DNA-based vaccine that can be delivered directly into the cells of the body using an innovative proprietary device. This smart device is a safe and effective way of delivering the vaccine to produce a rapid immune response.

A DNA-based vaccine is one that adds a distinct antigen DNA-coding sequence onto an immunized species’ cells. This type of vaccine can stimulate both the humoral and cellular branches of the adaptive immune system. INO-4800 is expected to stimulate B lymphocytes in the humoral immunity to produce antibodies — one of the most effective defences against invading viruses.

How effective is this vaccine?

INOVIO scientists are some of the leading coronavirus experts. Although there is limited information on their preclinical testing of INO-4800, they have gained authority through their research of another coronavirus vaccine. This DNA-based vaccine known as INO-4700 is used to fight MERS-CoV.

After completion of a Phase 1 trial of their MERS-CoV vaccine, they found it to be well-tolerated by test subjects. INO-4700 generated an astounding 95% efficacy in generating elevated levels of antibody responses. Their success in Phase 1 has prepared them to initiate a Phase 2 vaccine trial in the upcoming months.

This data, along with that of INO-4800 will provide further insight into the efficacy and safety of coronavirus vaccinations.

How is this vaccine stored?

Similar to Altimmune’s AdCOVID vaccine, INO-4800 has long-lasting stability which does not require frozen storage and transportation.

2.  Altimmune — AdCOVID

Altimmune has developed a single-dose intranasal Covid-19 vaccine known as adCOVID. They are currently in their preclinical phase of testing; however, they plan to put this vaccine into Phase 1 trials in the upcoming months.

What’s an intranasal vaccine?

An intranasal flu vaccine is administered via nasal spray. This simple vaccine delivery is well-tolerated in most patients as it does not require any invasive needles.

The purpose of targeting the local mucosal immunity with an intranasal vaccination is vital to both blocks the site of infection and transmission at its origin.

How effective is this vaccine?

AdCOVID has been successful throughout the current animal studies which demonstrate a healthy activation of the three major components of the immune system. With only a single dose, it’s shown to accomplish the following:

  • Serum neutralizing activity: demonstrating high levels of serum neutralizing activity by day 28 is shown to be even more effective than the minimum recommended by the FDA.
  • Mucosal immunity: this vaccine has shown a significant increase in mucosal immunoglobulin (IgA) which helps to stop both the infection itself and the spread of infection at the origin.
  • T cell immunity: the vaccine is also a potent stimulator of antigen-specific killer T cells by day 10. T cells were active primarily in the lungs of the mice that were tested.

How is this vaccine stored?

This vaccine is superior to any other in terms of its stability or shelf life. Unlike other vaccine candidates, AdCOVID is stable for years when refrigerated. It can also withstand up to 1-2 months at room temperatures.

This is an important component when it comes to distribution logistics. AdCOVID can easily be transported into rural locations for community clinics and pharmacies where ultra-low freezers are not available.

3.  Amgen and Adaptive Biotechnologies

In an early-stage collaboration between Amgen Incorporated and Adaptive Biotechnologies Corporation, they have developed a promising antibody treatment for Covid-19.

What’s an antibody treatment?

Antibody treatment is an immunotherapy technique used to treat certain viruses like Covid-19.

Antibodies are proteins made by humans to recognize viruses and other foreign invaders. When a virus enters the body, these antibodies will quickly identify and bind to it, blocking its entry into our cells. This is a vital process towards preventing disease transmission as well as preventing it from progressing further.

Antibodies are all specific to their virus — and because Covid-19 is unfamiliar to all of us we don’t have these proteins readily available to eliminate the virus. Similar to vaccination, an antibody treatment can stop the rapid spread of disease in a population by treating it at the source.

How does this treatment work?

Through rapid screening of B cell receptors from previously recovered cases of Covid-19, Adaptive Biotechnology can identify thousands of naturally occurring antibodies in their patients. Amgen will then select and develop antibodies that specifically bind and deactivate the SARS-CoV-2 virus.

Eventually, the newly synthesized antibodies will be administered into Covid-19 positive cases to effectively eliminate the virus.

How is an antibody treatment administered?

Amgen and Adaptive Biotechnologies have developed a monoclonal antibody therapy to treat Covid-19. This form of antibody treatment is achieved by giving the patient an infusion directly into the bloodstream.

Laboratory-synthesized antibodies are not long-lasting. They require multiple infusions for protective effects.

Next steps for this antibody treatment

Currently, the monoclonal antibodies are being tested for cancer and as a ‘triple antibody therapy’ to treat Ebola — both of which are helping to further the research in Covid-19 treatments.

Scientists estimate there will be more than one generation of antibodies to enter the Covid-19 scene. Also, Amgen is currently testing ‘Otezla’ as an oral psoriasis drug. This therapy is used to treat respiratory distress in severe cases of Covid-19 patients. 

4.  CytoDyn — Leronlimab

CytoDyn Incorporated is another preclinical biotechnology company similar to that of Amgen and Adaptive Biotechnologies. CyoDyn is based in Vancouver, British Columbia and is currently testing its experimental drug in two kinds of Covid-19 patients.

What is this treatment?

Through much of their research, they found the ‘cytokine storm’ to play a role in the development of acute respiratory distress syndrome (ARDS) in Covid-19 cases. More specifically, ARDS was a result of the rapid accumulation of neutrophils within the pulmonary and alveolar space which initiates the cytokine storm immune response.

Leronlimab (PRO 140) is being proposed as a treatment candidate for mild-to-moderate symptoms of respiratory complications. The primary role of Leronlimab is to prevent the cytokine storm response entirely. This is accomplished by inhibiting neutrophil migration to the site of inflammation.

Although not currently approved for any indication, CytoDyn has been studying the experimental application for people with HIV and specific forms of metastatic breast cancer.

How effective is this treatment?

The laboratory data provided by CytoDyn revealed that patients who were treated with Leronlimab for Covid-19 showed the following:

  • Increased CD8 T-lymphocyte percentages by day 3
  • Normalized CD4 to CD8 ratios
  • Reduced cytokine production

By the 1 week mark, data suggests a steady trend towards the restoration of proper immune functioning which is critical to achieving symptom management and early recovery.

What are the next steps for this treatment?

Currently, CytoDyn has administered Leronlimab to 15 severely ill patients at 4 different hospitals under an ‘emergency investigational new drug’ (EIND) granted by the FDA. The company plans to conduct a Phase 2 randomized clinical trial for patients with mild-to-moderate cases as well as a Phase 2b/3 trial on severe cases.

5.  Gilead Sciences — Veklury

Gilead Sciences Incorporated is a long-term biopharmaceutical company based in California. They’ve developed a Covid-19 treatment known as Veklury (remdesivir) that’s currently approved for emergency use only. Veklury still requires further clinical analysis to receive FDA approval.

What is this treatment?

Veklury is a nucleotide analog containing a nucleic acid analogue, a sugar, and a phosphate group with 1-3 phosphates.

Veklury stimulates antiviral activity for a broad spectrum of viruses including Ebola, SARS, MERS, and most importantly SARS-CoV-2. This antiviral activity is seen both in vitro and in vivo in animal models.

How effective is this treatment?

Gilead Sciences has reported promising results for their two clinical trials previously conducted. In their randomized, controlled trial, Covid-19 patients taking Veklury demonstrated a median recovery time of 11 days compared to 15 days in those taking the placebo.

Since their two drug trials, Gilead Sciences has received emergency use authorization from the FDA in May of 2019 to implement their treatment into certain hospitals across the U.S. It’s now authorized for temporary use as a Covid-19 treatment in 50 countries across the globe.