Finally it is china- Sinopharm vaccine-first phase 3 trial | October 2020

Chinese vaccine - Sinopharm- Phase III trial

The Wuhan Institute of Biological Products, affiliated with Sinopharm becomes the first vaccine candidate to show beneficial safety and immunogenicity in phase I/II  clinical trials. China National Pharmaceutical Group Sinopharm (Sinopharm) is to begin a phase III trial in UAE and it is the first Chinese vaccine candidate that conducts the overseas clinical trial.

During the Phase I trial, 180 volunteers have been vaccinated and recently in phase II trial, 1000 employees of Sinopharm have been vaccinated and it showed safe and effective with adverse effects far lower than other vaccine candidates, a statement given by Sinopharm's officials. Sinopharm's Beijing Institute of Biological Products claims that they have the capacity to 20 million doses of the vaccine a year, while the company's institute in Wuhan will be capable of producing 100 million doses annually.

13 Experimental vaccines have entered human clinical trials and more than 120 others are in the earlier stage of development. 3 vaccine makers are set to race up as they are to enter later clinical trials. They are U.S-Moderna, China-Sinovac Biotech, UK’s Oxford-AstraZeneca. Among the vaccine candidates, china has six vaccine developmental projects that are undergoing human trials.

Top Candidate’s for COVID-19 Vaccine

1.         Oxford- AstraZeneca vaccine (PhaseII/III)

This collaborative  Vaccine project between  AstraZeneca and the University of Oxford, the AZD122 vaccine based on chimpanzee adenovirus called ChAdOx1 is to begin phase II/III testing in the UK and brazil. AstraZeneca has already begun for mass production of vaccines and plans to produce 2 billion doses by September.

2.         Moderna vaccine (phaseII)

This US-based firm is developing a messenger RNA based vaccine, its mRNA-1273 vaccine is set to begin testing on 30,000 people by July and this firm expects that the vaccine would be available by early 2021.

3.         Pfizer-BNTECH vaccine (PhaseII)

Pfizer has partnered with German firm BNTECH, 4 formats of mRNA based vaccine candidates are being tested in the U.S and Germany. Pfizer believes that their vaccine could be ready by the end of October 2020.

4.         Sinovac Biotech vaccine (Phase II)

This Chinese based firm is testing an inactivated vaccine called Coronavac and is preparing for phase III trials in China and Brazil. Based on Phase I/II data, it is safe and elicits an immune response in human trials.

What are the stages in the development of  a Vaccine

Preclinical stage: Invitro/Invivo studies

Invitro- A vaccine to be tested on cell lines.

InVivo- Vaccines will be tested on animals such as mice/monkeys and check for the immune response.

Phase I trial:  Experimental Vaccine will be given to humans and the subject ranges between 20-80 to test the safety and dosage of the vaccine. whether it stimulates the immune system.

Phase II trials- A large of people will be involved in testing and they will be differentiated into groups such as children and elderly people. This stage will be dealing with vaccine safety, immunogenicity, proposed doses, schedule of immunization, and delivery methodology.

Phase III trial- In this stage, the Vaccine will be given to 1000s of people for testing the safety and efficacy. After this, the concerned institution/organization will Submit application to the regulatory authority for approval.

Generic drugs | Remdesivir | CDCSO | DCGI | Medical masks | Cipremi | Covifor | Cipla | Hetero | Fabiflu | Glenmark

Medical Masks are Everlasting

Historians  believe that during the plague attack in Europe, Doctors started to wear masks that were made of leathers to prevent from bad air. These were preserved at Deutsches Historisches Museum in Berlin. Later on, microbiologists who were working on bacteria started to wear face masks in order to prevent microbes and dust particles.

It was in the year 1910, pneumonic plague strikes in Manchuria (a place in china), medical professionals adopted to wear face masks to prevent from this airborne disease. Later on, normal people and medical professionals adapted to wear face masks in order to prevent infection.

Types of masks and respirators

	Face mask ( Cloth or paper masks)	Surgical mask	N95 respirator	Surgical  N95 respirator
Purpose	Prevents  large particles expelled by the wearer from reaching the environment.	To be used as a physical barrier to protect from large droplets of blood or body fluids.	Reduces exposure to very small airborne particles or contaminants. May not protect against sprays and direct liquid splashes.	To be used as physical barriers from large droplets of blood or body fluids as well as small particles.
Filtration efficiency	Not applicable	Bacterial filtration efficiency above 95%	Minimum 95% against  particulate aerosols.	Minimum  95% against  particulate aerosols.
Fluid resistance	Absent	Yes	Not applicable	Yes

Generic version of Remdesivir

What are Generic Drugs?

Generic drugs are a type of medications that are copies of branded drugs which have the same dose, route of administration, quality, and performance.

Cipla and Hetero from India got approval to manufacture the generic version of Remdesivir for the treatment of COVID-19. Central Drug Control Standard Organisation (CDCSO) office of DCGI had granted permission to market Gilead science anti-viral drug Remdesivir in India for "restricted emergency use" on hospitalized COVID-19 patients.

Cipla launches generic version Remdesivir under the brand name ‘Cipremi’. The generic version will be available under the brand name ‘Covifor’(Hetero).  This ‘Covifor’ will be manufactured at hetero in Hyderabad.

Covifor (Remdesivir) will be available in 100mg vial (injectable) that will be administered intravenously under the supervision of healthcare practitioners. This drug will be available for use in hospitals. The supply will begin in a week. The price of the drug ranges between Rs.5000-6000 per 100mg vial. Cipla has not yet disclosed the pricing.

Based on a preliminary study conducted by Cipla,  results from ACTT-1(Adaptive COVID-19 Treatment  Trial) which had randomized clinical trials conducted with Remdesivir in 1063 patients, most of them were on oxygen support across U.S, Europe, and Asia. The mortality rate in the study was found to be 7.1% among given Remdesivir and 11.9% given through placebo.

Other pharma companies such as Zydus Cadila, Mylan, DRL and BDR pharma have submitted an application to DCGI to manufacture and market Remdesivir in India.

Many of us may be aware that Glenamark pharmaceuticals launched antiviral drug Favipiravir, under the brand name ‘FabiFlu’. This drug could be used for treating mild to moderate COVID-19 patients. This drug is available as a 200 mg tablet at a maximum retail price (MRP) of Rs 3,500 for a strip of 34 tablets. Each tablet costs Rs.103 and added that it is the first oral medication that is been approved in India for the treatment of COVID-19.

Story of Corona viruses | Pandemic | COVID-19 | Infection | MERS | SARS-Cov | Diseases

Story of Coronavirus

Everyone might be aware of COVID-19. But only a few may know the different strains of coronaviruses.  In the late 1930s, Coronaviruses were discovered in chicken that was infected by infectious bronchitis virus (IBV) but later in the 1960s only human Coronaviruses were discovered. The first strain was termed as B814 (number of the nasal washing) from a study conducted at Common Cold Unit of the British Medical Research Council by Kendall, Malcom Byone, and David Tyrrell. They found out that the virus could not be cultivated by a standard testing procedure. Eventually, Dorothy Hamre and John Procknow at The University of Chicago isolated a novel virus 229E, when both were inoculated, it caused cold in the volunteers, and the virus was inactivated by ether.

Common 4 human coronaviruses that have a mild infection

• 229E (alpha coronavirus)
• NL63 (alpha coronavirus)
• OC43 (beta coronavirus)
• HKU1 (beta coronavirus)

The other 3 types of coronavirus that causes severe infection:

1. MERS-CoV (Middle East Respiratory Syndrome, or MERS), is caused by the beta coronavirus group. The first case was reported in June 2012 in Saudi Arabia. The mode of infection is found to be from camels but some  scientists believe that it may be from bats. A larger outbreak occurred in South Korea (2015)  and in Saudi Arabia(2018). There is no specific vaccine or treatment for this disease.
   
2.  Severe acute respiratory syndrome coronavirus(SARS-CoV), is a type of coronavirus that infects bats. It also infects humans and certain mammals. It is a member of beta coronavirus. Two strains have been found for the outbreak during 2002-04. Bats are the main host for many of the strains of SARS-Cov. In 2016, WHO has found out that the future epidemic may occur after the ebola outbreak.
3. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a  strain of SARS-Cov that causes COVID-19. The origin of this virus is believed to be from Wuhan, China. In January 2020, human to human transmission was confirmed. This disease has been declared a  pandemic by WHO.
   

541–542	Plague of Justinian
1346–1350	The Black Death
1899–1923	Sixth cholera pandemic
1918–1920	Spanish flu (H1N1)
1957–1958	Asian flu (H2N2)
1968–1969	Hong Kong flu
2009–2010	Swine flu (H1N1)
2019	COVID-19

2

 Fig: List of  Pandemic Diseases

                            

 

 When humans stop loving nature, Nature starts to love humans