Pak-Vac - Over 90% Effective Single Dose Vaccine

PAKVAC-CANSINOBIO IS A SINGLE DOSE VACCINE

In the human body, vaccines develop immunity. These are the immunity boosters to a certain disease that is either pandemic or an outbreak of a dangerous disease in a population. So the immunization in childhood/adulthood; vaccines play a key role to protect against diseases. 

Convidecia i.e. locally known as CansSinoBIO or PakVac (Ad5-nCoV) is the genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein. This is a single-dose vaccine that is based upon Viral Vector Vaccine Technology.

Shortly, the Viral Vector Vaccine Technology refers to the technique which involves the incorporation of Viral content into a Vector that carries the Viral content in the body.

Convidecia is approved for some countries in Asia, Europe, and Latin America. Production capacity for Ad5-NCov should reach 500 million doses in 2021. Manufacturing will take place in China with filling and finishing of the vaccine additionally also taking place in Malaysia, Mexico and Pakistan.

In May, Pakistan began filling and finishing 3 million doses a month at the National Institute of Health, which would be branded as PakVac for domestic distribution

Pak-Vac is Approved By:

Convidecia is a viral vector vaccine similar to AstraZeneca's AZD1222. While the efficacy rates were lower than the Pfizer–BioNTech and Moderna vaccines (WHO emergency Use Listed Vaccines)

·        On 25 June 2020, China approved the vaccine for limited use by the military. In February 2021, China approved the vaccine for general use.

·        In February 2021, Mexico approved the vaccine for emergency use.

·        In February 2021, Pakistan approved the vaccine for emergency use.

·        In March, Hungary approved the vaccine for emergency use.

·        In March, Moldova authorized use of the vaccine.

·        In April, Chile Obtained Emergency Use Authorization.

·        On 15 June 2021, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued conditional registration for emergency use of the vaccine.

Clinical Trials:

The new Ad5 nCoV vectored COVID-19 vaccine evaluated in the phase 1 trial is the first to be tested in humans. Afterward, In September 2020, Phase III Trials had been started which has been concluded.

The phase III clinical trial of Ad5-nCoV has vaccinated more than 40,000 volunteers in 78 clinical trial sites across five countries over three continents, Pakistan, Mexico, Russia, Chile, and Argentina.

EFFICACY OF PAK-VAC

14 Days Testing indicated 68.83% effectiveness in preventing all symptomatic COVID-19 disease and 95.47% effective in preventing severe COVID-19 disease

28 Days Testing indicated 65.28% effective in preventing all symptomatic COVID-19 disease and 90.07% effective in preventing severe COVID-19 disease

Pak-Vac Clinical Trials Description & Goals:

Design Model: The phase III clinical trial of Convidecia is a global multicenter, randomized, double-blind, placebo-controlled, adaptive design.

·    Launched in September 2020, the phase III clinical trial of Convidecia to evaluate the efficacy, safety, and immunogenicity of Convidecia in adults 18 years of age and older.

·   All participants receive a single dose of either Convidecia or a placebo vaccine on Day 0 and are monitored for vaccine candidate efficacy and incidence of Severe Adverse Events for a duration of 52 weeks.

·   The primary objective is to calculate the efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) symptomatic COVID-19 disease, nonetheless of severity, occurring 28 days to 52 weeks after vaccination.

·   COVID-19 rates in the Convidecia group will be compared with COVID-19 rates in the control group (who has not been given any dose). The primary safety objective is to evaluate the incidence of Severe Adverse Events and medically attended adverse events within 52 weeks after vaccination in all participants.

Nowadays, Convidecia i.e. PakVac is under the fourth phase of clinical trials. The process of vaccination is underway. PakVac is approved as safe & effective for emergency use vaccine.

Source: CanSinoBIO, US National Library of Medicine