Recently, it has been reported from various sources that COVID-19 vaccine in China has started large-scale voluntary emergency vaccination at its own expense, and the vaccination targets even include primary and secondary school students.
On September 5th, three COVID-19 vaccines in China were officially unveiled in China International Fair for Trade in Services in 2020. Two inactivated vaccines are from SINOPHARM’s Beisheng and Wusheng, and the other is SINOVAC’s inactivated vaccine.
Last night, a colleague gave me a spy photos of inactivated COVID-19 vaccine instructions from Wuhan Biological. Dr. Tao combed out six of them for your reference. The quality of spy photos is not too high, but you can see the font clearly.
Aspect 1: The virus strain used is WIV04 strain.
Viral vaccines are particular about the selection of virus strains.
Although they are all the same virus, there may be great differences in characteristics. It’s like we are all Chinese, but Yao Ming is tall, Pan Changjiang is short, and the descendants of Yao Ming are also tall, and the descendants of Pan Changjiang are short. If you want to choose basketball talents, it is wise to choose the descendants of Yao Ming.
The virus strain selected for vaccine production needs to be excellent in vaccine mass production, immune effect and safety. However, the virus is so small that it is impossible to see this difference intuitively, so it needs to be screened among the collected virus strains, which requires a little luck.
This inactivated vaccine of Wuhan Bio uses WIV04 strain, which does not mean that other inactivated vaccines in China must also use this strain (but it is highly probable). WIV04 strain of virus comes from a patient in Jinyintan Hospital, China Academy of Sciences, and its login number is SAMC133237 and MN996528 in GenBank.
Aspect 2: The applicable population is ≥3 years old.
The applicable population is followed by a sentence: "Inoculate after the clinical trial data of minors such as those not recommended by adults come out". The implication is that no one over 3 years old can not be vaccinated, but it is recommended to wait for the data to come out for vaccination.
This kind of writing is unprecedented in any vaccine in the past.
Aspect 3: A single dose contains 200WU of virus antigen.
Previously, I learned that the content mentioned in the clinical trial paper of inactivated vaccine was recorded in ug (microgram), but this is 200WU, and the unit is completely different. I don’t know what the conversion relationship is between the two, and I have read so many vaccine instructions, including U, IU, EU, LgCCID50 and ug, but this is the first time I have seen such a unit as WU.
Because the inactivated vaccine contains complete virus particles, I guess this WU means Wholeviral Unit, that is, whole viral unit. If I am wrong, please tell me the true meaning.
Aspect 4: The instructions list three rare adverse reactions.
I don’t know whether the clinical trials really found three kinds of rare adverse reactions in the instructions, including allergic skin rash, Henoch-Schonlein purpura and anaphylactic shock.
According to my experience, rash is possible to be found, but purpura and shock are extremely rare, and the incidence rate is calculated from 1/100,000 to 1/100,000. At present, the number of participants in clinical trials is far from the order of magnitude of one such incident.
Therefore, I highly suspect that purpura and shock are only speculative publicity, not the real findings of clinical trials. I object to attributing these health damages to adverse reactions of vaccines without causal cases, which will make the public overestimate the safety risks of vaccines.
Aspect 5: The validity period is tentatively set at 36 months.
According to the stability of other inactivated vaccines, it is not a big problem to tentatively set 36 months.
However, before, what did I think about the low antibody value of China COVID-19 vaccine? A hidden worry of China vaccine is introduced in the article. Because the S protein indicated by the virus is unstable, it will gradually change from the initial pre-fusion conformation to the post-fusion conformation. If the storage time is prolonged, there are more and more S proteins in the fusion conformation, which may affect the quality of the antibody produced.
Therefore, we should pay attention to the transformation rate of S protein in vaccine over time.
Aspect 6: The approval number is to be determined, and the emergency use number is Weike Comprehensive Letter [2020] No.40.
Unprecedented, this is the first time that there is no official approval number in China vaccine instructions.
There are two official approval numbers of vaccines. Domestic vaccines are [National Medicine Standard S……] and imported vaccines are [Registration Certificate S …], where S means biological products.
Some vaccines in China are strategically reserved, but there are also official approval numbers. For example, the approval number of Ebola vaccine of Kangxinuo Company is [National Medicine Zhunzi S20170008], and the approval number of influenza pandemic vaccine of Beijing Kexing Company is [National Medicine Zhunzi S20080005].
Dr. Tao didn’t find the document [2020] No.40 of the Health Department Comprehensive Letter. If anyone knows it, please provide it to me by private letter.
Included in the topic #COVID vaccine science