Development notes on COVID-19 prevention vaccines and treatments

 

I. Vaccines development progress

II. Treatment development status

III.  Estimated time to release vaccines and treatments

IV. What to do before vaccines or cure comes out

Since CoVID - 19 first occurred in Wuhan, Hubei Province, China on December 1, 2019, As of April 28, 2020,
3 million people worldwide have been infected.

 In the meantime, countries around the world have been trying to develop preventive vaccines and treatments.

 

 Source : Future & Science, Merck

 

I. Vaccines Development Progress

 

 Along with the recent news that the candidates for treatment have failed in clinical trials, the world is attracting interest in vaccines.

In the case of vaccines, a few countries have been busy for vaccine development, and the most
popular ones are the American Moderna Therapeutics.

Moderna skipped the animal experiment and started clinical trials in humans in early March.
 
In this clinical trial, 45 healthy volunteers are checked for safety and immune effects.

If the clinical results show no serious side effects, hundreds of healthy volunteers will be recruited to conduct Phase II clinical trials.

Another vaccine developer in the United States is Innovio. Innovio plans to complete clinical trials 
by autumn and make one million doses by the end of the year for emergency use.

In China, clinical trials were also active, with five cases entering clinical trials,  the fastest of which is Cansino.

Cansino Biologics recently entered the world's first phase 2 clinical trial. This is only one month since the start of Phase I clinical trials.

It is said that it usually takes 10 years to develop a vaccine. The Ebola virus vaccine, the fastest ever, also took five years.

Following the United States and China, Britain and Germany have also started to develop vaccines.

"We are going to be the world's first COVID-19 
vaccine developing country by pouring everything," said British health minister Matt Hancock.

550 healthy adults aged 18-55 participate in the clinical trial of COVID-19 vaccine, which Oxford  started on April 23. It is the largest clinical trial ever conducted.

German Bioentech also got clinical approval for four vaccine candidates on the 22nd.

Then, when clinical trials in China revealed that Abigan worked, it began to rise again.

In addition, a Chinese research paper on Abigan was published in the British Medical Journal,
Nature.

At this time, when the Japanese Abe Prime Minister promoted Abigan, a domestic product,
to the United States, Abigan rose rapidly.

However, Japanese health authorities also concluded that the Abigan had no effect on 
patients with seasonal influenza A or B virus based on the Phase 3 clinical trial.

In addition, there was a controversy that the paper published in Nature also lacked evidence such as no clinical content.

In the meantime, when the papers that were published in Nature were deleted again in China, 
they raised doubts about the incompleteness of the papers.

On the other hand, Kaletra, an AIDS treatment, is being used in several places, and based on 
experience treated , it is expected to enter a  full-scale clinical trial.

However, clinical results revealed that even the expected Calletra had no effect.

Subsequently, hydroxy chloroquine, a drug for  malaria, is thought to have a side effect of co-administration with hygitromycin and is disappointed.

Lastly, Ramdesivir was a drug with a lot of potential around the world.

The patient was discharged after 2 weeks due to better progress after administration of ramdesivir.

Then the Ebola virus treatment Ramdesivir starts clinical trials in the hopes and expectations  of the world.
After waiting, there were some controversies, but  the results were not satisfactory.

In the Chinese clinic, 158 were given ramdesivir and 79 were given a placebo (fake medicine).
However, the Chinese clinical trial was discontinued due to difficulties in recruiting clinical participants  due to a decrease in patients.

As a result, the National Institutes of Health released updated guidelines for Corona 19 treatments on April 21 (local time).

The National Institutes of Health (NIH) has announced that there are no treatments to recommend  corona19 treatment, including Remedyvir.

 

 

II. Treatments development status

There were clinical trials for about 4 types of therapeutic candidates.

So far, no satisfactory results have been obtained.

There were a total of four drugs that were mentioned as candidates for the treatment of  COVID - 19.

These include the new influenza drugs Abigan, the Ebola virus treatment Ramdesivir, the AIDS treatment Caletra,  and the malaria treatment hydroxy chloroquine.

Among them, Abigan, although developed as an anti influenza treatment, was not effective against the H1N1 flu and was not effective against the Abola virus.

Then, when clinical trials in China revealed that Abigan worked, it began to rise again.
In addition, a Chinese research paper on Abigan was published in the British Medical Journal, Nature.

At this time, when the Japanese Abe Prime 
Minister promoted Abigan, a domestic product, to the United States, Abigan rose rapidly. However, Japanese health authorities also concluded that the Abigan had no effect on patients with seasonal influenza A or B virus based on the Phase 3 clinical trial.

In addition, there was a controversy that the paper published in Nature also lacked evidence such as no clinical content.
In the meantime, when the papers that were published in Nature were deleted again in China, they raised doubts about the incompleteness of the papers.

On the other hand, Kaletra, an AIDS treatment, is being used in several places, and based on experience treated , it  is expected to enter a  full-scale clinical trial.

However, clinical results revealed that even the expected Calletra had no effect.

Subsequently, hydroxy chloroquine, a drug for malaria, is thought to have a side effect of co-administration with  hygitromycin and is disappointed.

Lastly, Ramdesivir was a drug with a lot of potential around the world.

The patient was discharged after 2 weeks due to better progress after administration of ramdesivir.

Then the Ebola virus treatment Ramdesivir starts clinical trials in the hopes and expectations of the world.

After waiting, there were some controversies, but the results were not satisfactory.
In the Chinese clinic, 158 were given ramdesivir and 79 were given a placebo (fake medicine).

However, the Chinese clinical trial was discontinued due to difficulties in recruiting clinical participants due to  a decrease in patients.

As a result, the National Institutes of Health released updated guidelines for Corona 19 treatments on April 21
(local time).

The National Institutes of Health (NIH) has announced that there are no treatments to recommend corona19 treatment, including Remedyvir.

 

 

III. Estimated time to release vaccines and treatments

 
■ Vaccines

So, when will vaccines and therapeutics be commercialized?

In the case of vaccines, Modena in the US is currently in Phase I clinical trials and The results  will come out as early as July or August.

According to researchers, phase II clinical trials begin in the fall and can be completed as early as June 2021 and  late at the end of 2020.

Modena is expected to be more resilient as it receives $ 483 million from the US Biomedical Advanced Research  & Development Authority(BARDA).

This is Innobio Pharmaceuticals, which entered the clinical trial phase of Corona 19 vaccine for the second time  in the United States.

Innobio said on April 7 that it was approved for the clinical trial plan for the DNA vaccine candidate INO-400.

In China, clinical trials for vaccine development are being actively conducted.

In China, the recombinant corona 19 virus vaccine made from adenovirus vectors has been launched.

In this clinical trial, 108 people aged 18 to 60 years in the Wuhan area were vaccinated before entering quarantine  for 14 days.

In addition, Britain, the host country of vaccines, and Germany, Europe's leading country, also competed in vaccine  development.

However, it is not easy to predict the expected date of vaccine development.

 

 

■ Treatments

 
The candidates for treatment did not achieve satisfactory results in the clinical trial. However, the drugs that still have to be examined for further use after extensive clinical trials are ramdesivir and hydroxy chloroquine.

Remedyvir cured a serious patient with a very poor prognosis.

In a clinical trial at the University of Chicago in Phase 2, 125 patients who received ramdesivir in a
 clinical trial reported rapid recovery from high fever and respiratory symptoms, and almost all patients  were discharged in less than a week. At this time, 113 patients were said to be severe.

However, in a clinical trial in China, it was found that ramdesivir had no effect as the mortality rate  of patients who received ramdesivir was higher than that of the control group.

In these two distinctly different tests, we can predict the following possibilities:


1. The efficacy of Ramdesivir depends on the severity of the patient's illness (mild or severe).

2. Most of the patients at the University of Chicago are severe and the clinical trials in China may
have been primarily mild.

Although the results of the two tests are different, it is difficult to make an accurate comparison, but 
only in clinical conditions, the accuracy of Chinese  clinical trials that measured the effects of ramdesivir through comparison with a control group is high.

The weakness of the University of Chicago clinical trial is that there is no comparison group.

Therefore, it may be that patients who were discharged after being cured in less than a week 
could have been discharged at the time without administration of ramdesivir.

Although the clinical trial in China was not a complete clinical trial due to the difficulty in recruiting participants, it was sufficient to confirm that the results of the study did not have the effect of  Ramdesivir.

 As of this writing, another study has been published. It is only six days after the report on April 24 
that the clinical trial of Ramdesivir was unsuccessful in China.

Fauci, director of the National Institute of Allergic Diseases, USA, said on April 29 (local time) that COVID-19 therapeutic candidate Ramdesivir had a positive effect in clinical trials.

It was reported that 1090 patients participated in the trial and the patient recovery time improved 
from 15 days to 11 days. He also said it proves that drugs can block the virus.

In this regard, local media reported that the U.S. FDA is considering a plan to approve  Ramdesivir for emergency use.

On the other hand, there was a French clinical result that hydroxy chloroquine had a good effect when used in combination with azithromycin.

The research team of Didier Raoult, a professor at the Marseille Infectious Disease Research Institute in France, influenced President Trump of the United States to issue FDA approval for hydroxychloroquine.

Professor Raoul's team administered hydroxy chloroquine and the antibiotic azithromycin to 
36 patients with corona virus, and on the 5th day, the virus test confirmed 100% negative results.

However, contrary research results came from China. Researchers from the Public Health Clinical Center at Fudan University in China have found that  hydroxy chloroquine was not effective in patients with
 COVID-19.

Professor Lu's team divided 30 of the COVID-19 patients in half, and 15 were given hydroxy chloroquine. Rest and oxygen were used for the remaining 15 people,  and interferon and calletra were used if necessary.

As a result of measuring the virus after 7 days, the administration group was 86.7% (13/15 persons) and the comparison group was 93.3% (14/15 persons).

In addition, there are also clinical results that require caution due to side-effects related to heart disease when using hydroxychloroquine and iztromycin.

However, many people say that hydroxy chloroquine has been cured in a few days after administration, and there are surprisingly many countries that have already used this drug for interim use for  patients with poor prognosis. So this drug needs more clinical trials from more people.

If made from scratch, it will take more than 10  years. However, development time can be significantly shortened if existing drugs, such as lamdesivir and hydroxy chloroquine, are safe and effective to use even after clinical trials in COVID- 19.

 Therefore, the outcome of additional clinical trials in the future will determine how soon the treatment will be released.

In addition to chloroquine, there are many alternative treatments such as Caletra, an AIDS 
treatment, Abigan, an influenza treatment, Avidol, an influenza treatment, Rebetol, a hepatitis treatment, and Sovaldi, a treatment for hepatitis C.

Among these, drugs that show the safety and effectiveness of COVID-19 first after going through as many clinical trials as possible will be therapeutic agents.

As of now, Ramdesivir is not as satisfied as expected, but there is a high probability of becoming the
 first cure.

IV. What to do before a vaccine or cure comes out

Wear a valid mask and wash your hands often.

Cover your arms with coughing or sneezing.

A thorough diagnosis of the suspected patient or the person who was in the same place as the 
confirmed patient should be screened and the quarantine treatment should be performed.

In the case of an infected person in a densely vulnerable group, especially a base disease vulnerable to a virus or a facility with a disability, the group should be cohortly isolated and the entire group should be diagnosed as infected.

The social distance management campaign (keep the distance over 2m) is thoroughly managed to
 prevent infection.

What we need to do to respond to the horrible infectious COVID-19 is very easy and trivial. However, there is no special treatment or preventive vaccine, so it should be done as it is the best way to minimize infection damage. Thank you for your reading.

 

Mansur