|Application:||COVID-19 Vaccine Testing Chamber||Test Method:||ASTM F1608 Standard|
|Test Standard:||YY/T 0681.10-2011||Vaccine Type:||Aerosol Inhalation Vaccine|
News from China News Network dated from Aug 9,2021
The phase I clinical trial data of the recombinant new crown vaccine (adenovirus vector) for aerosol inhalation developed by the team of Chen Wei, an academician of the Chinese Academy of Engineering and a researcher of the Academy of Military Medical Research of the Academy of Military Sciences, is published in the international authoritative medical journal "The Lancet Infectious Diseases" online published. This is the first published clinical trial result of mucosal immunity of the COVID-19 vaccine in the world.
The results of the study show that the recombinant new crown vaccine for inhalation has good safety, tolerance and immunogenicity. A single dose of the aerosolized vaccine requires only one-fifth of the dose of the intramuscular vaccine and produces a level of cellular immune response comparable to that of intramuscular injection. Aerosol inhalation booster immunization on the 28th day after intramuscular injection of recombinant COVID-19 vaccine can induce the production of high levels of neutralizing antibodies. The clinical trial was launched in Wuhan on September 29, 2020, and was jointly completed by Chen Wei's team and Wuhan University Zhongnan Hospital. Phase II clinical trials are progressing in an orderly manner.
The vaccine for aerosol inhalation is the same in formulation and production process as the recombinant new crown vaccine that has been approved for marketing with conditions. Compared with the cellular immunity and humoral immunity formed by the injectable COVID-19 vaccine, the aerosol inhalation vaccine can induce the human body to produce mucosal immunity, preventing infection and blocking transmission at the first pass of virus invasion. This new kind of COVID-19 Vaccines do not need "injections", but only need to inhale the vaccine into the respiratory tract and lungs through aerosol inhalation equipment, so as to obtain "triple protection" of mucosal immunity, cellular immunity and humoral immunity.
According to reports, the aerosol inhalation vaccine can be vaccinated with only one "inhalation", which is safer and more convenient, and is suitable for the promotion and use of large-scale people.
This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.
A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.
Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.
This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Contact Person: Mr. Martin Zeng