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The leadership of Sinopharm was dismissed, Sinovac stopped production, don't confuse these with the effectiveness and safety of vaccines

author:Emergency doctor Da Liu

In January this year, the Sinovac vaccine was discontinued, and on April 26, Yang Xiaoming, the former chief engineer and chief scientist of China National Medicine, was dismissed as a deputy to the National People's Congress on suspicion of serious violations of discipline and law. Since the inactivated vaccines of Sinovac and Sinopharm are the most used new crown vaccines in China, these two events have inevitably caused many people to worry about the safety of the previous inactivated vaccines, and some vaccine conspiracy theories are also taking advantage of the trend to harvest a wave of traffic.

However, the truth is that whether it is Sinopharm or Sinovac, several inactivated vaccines have published sufficient efficacy and safety data in the past three years or so. In the process of putting the inactivated vaccine into use, there have indeed been people in charge of the company who have said something extremely problematic scientifically, and the effectiveness of the inactivated vaccine is indeed not as good as the mRNA vaccine that was first developed and used in Europe and the United States at that time. However, we should not confuse different issues, let alone be intimidated by conspiracy theories.

Data on inactivated vaccines are published and internationally recognized

Vaccines are the same as any other drug, and their effectiveness and safety are based on data. It's not that today's so-and-so academician said that it would be good, and tomorrow it would be bad if so-and-so expert fell off. Viruses don't mutate like this, let alone vaccines?

Specific to the inactivated vaccines of Sinopharm and Sinovac, researchers have announced the results of phase III clinical trials since 2021. The result here is not that the company leaders with conflicts of interest say that the vaccine is effective, but that the vaccine is effective and safe after multiple mechanisms such as peer review and independent international expert review.

Sinovac and Sinopharm vaccines actually have three vaccines: Sinovac inactivated vaccine, Sinopharm Beijing and Sinopharm Wuhan. Sinovac's Phase III clinical trial in Brazil was first published in January 2021 by local researchers in Brazil. On April 29, 2021, the WHO spent a day evaluating whether the Sinopharm and Sinovac vaccines met the WHO's criteria for emergency authorization for COVID-19 vaccines. In this meeting, both Sinopharm Beijing and Sinovac provided multiple efficacy, safety, and immunogenicity data, including the interim analysis of phase III clinical trials.

The leadership of Sinopharm was dismissed, Sinovac stopped production, don't confuse these with the effectiveness and safety of vaccines

The data from the third phase of Sinopharm cited in the WHO evaluation was later published in the top international medical journal JAMA on May 26, 2021, including the Sinopharm Beijing and Sinopharm Wuhan vaccines:

The leadership of Sinopharm was dismissed, Sinovac stopped production, don't confuse these with the effectiveness and safety of vaccines

In the study, more than 13,000 subjects vaccinated with Sinopharm Beijing and Sinopharm Wuhan were 78.1% and 72.8% effective against symptomatic COVID-19 (original virus strain and alpha virus strain) after receiving the second dose, i.e., completing immunization.

The leadership of Sinopharm was dismissed, Sinovac stopped production, don't confuse these with the effectiveness and safety of vaccines

Such publicly available data is the basis for the WHO to provide emergency use authorization to Sinovac and Sinopharm in May 2021. That is to say, we emphasize that the new crown inactivated vaccine has published data and has been independently certified internationally.

Later, many places, including Brazil, Chile, Argentina, Hong Kong, etc., also published a lot of tracking data of inactivated vaccines in the real world, which further provided evidence that these vaccines were safe and effective

The father of the new crown vaccine said that it has nothing to do with vaccines

The corresponding author of the JAMA paper for the phase III clinical trial of Sinopharm is Yang Xiaoming. The media reported that the time of his fall was April 26, and it is difficult not to sigh, almost exactly 3 years ago (April 29, 2021), the Sinopharm vaccine was reviewed by the WHO.

Nowadays, many articles on the Internet call Yang Xiaoming the "father of the new crown vaccine", which is debatable. Yang is the leadership of Sinopharm, and he must have played an important leadership role in the research and development of Sinopharm's new crown vaccine, but can this be said to be the father of Sinopharm's new crown vaccine? Not necessarily, after all, behind any vaccine is the result of the efforts of many R&D and production personnel. What's more, even if the new crown vaccine is in China, Sinopharm is not the only one.

We do not know the specific reason for Yang's fall, and we believe that the relevant information will be announced in the near future. However, there is no need to link Yang's violation of discipline and law with the effectiveness and safety of the new crown vaccine, especially since the latter has sufficient scientific verification by researchers other than Sinopharm.

No matter how much Yang played a role in the Sinopharm vaccine, for those who have received this vaccine, they only need to remember that an independent international organization such as the WHO has reviewed this vaccine and recognized its safety and effectiveness.

Inactivated vaccines do have shortcomings

Of course, Sinopharm, Sinovac and other inactivated vaccines also have shortcomings - these shortcomings are also based on public research. Their immunogenicity is significantly weaker than the mRNA vaccines that were put into use abroad (mainly in Europe and the United States) during the same period, that is, in the three years of the epidemic, many people have heard of how much antibody titer is after vaccination.

Weak immunogenicity means that the neutralizing antibodies formed after vaccination with inactivated vaccines are much lower than those of mRNA vaccines, and recombinant protein vaccines with highly effective adjuvants are used, resulting in lower effectiveness of inactivated vaccines. Sinovac's Phase III clinical trial in Brazil was 51% effective in the interim analysis, and Sinopharm's Phase III clinical trial was more than 70% as mentioned above, compared to about 95% in the Phase III clinical trial conducted at the same time for the two mRNA vaccines. The results of different clinical trials cannot be easily compared, but we can still see trends.

The lower effectiveness is not only reflected in the lower efficacy numbers observed in the Phase III clinical trial, but also in the subsequent epidemic prevention practice. For example, vaccine effectiveness declines over time, and a lower starting point for effectiveness results in a shorter duration of protection for inactivated vaccines. Similarly, there are the challenges of mutant strains. The emergence of the Omicron mutant strain at the end of 2021 with strong immune escape has had a serious impact on the effectiveness of all new crown vaccines, but the inactivated vaccines, which are not effective enough, are undoubtedly in the worst situation.

The poor situation of vaccine effectiveness will eventually affect the situation of those who have been vaccinated. This has also played out in the real world, Hong Kong suffered the first wave of Omicron epidemic at the end of 2021 and early 22, according to the analysis of local scientists, the elderly vaccinated with 1 or 2 doses of Sinovac inactivated vaccine, the effectiveness of preventing severe disease and death, is significantly lower than the same vaccination of 1 or 2 doses of mRNA vaccine:

The leadership of Sinopharm was dismissed, Sinovac stopped production, don't confuse these with the effectiveness and safety of vaccines

Later, the booster shots in Chinese mainland switched to the use of non-inactivated vaccines, in fact, because of the shortcomings of the above-mentioned inactivated vaccines with low immunogenicity and weaker effectiveness. But we also need to emphasize that these weaknesses do not mean that inactivated vaccines are ineffective or unsafe. During the first wave of the Omicron epidemic in Hong Kong, the new crown mortality rate set a world record, and the main reason was not that Hong Kong used inactivated vaccines, but because Hong Kong's population is seriously aging, and many of the elderly at the highest risk of the new crown have not been vaccinated with a single shot.

The leadership of Sinopharm was dismissed, Sinovac stopped production, don't confuse these with the effectiveness and safety of vaccines

Some of the claims about inactivated vaccines are misleading

Another thing that needs to be faced is that there were indeed some unscientific claims and debatable practices when the inactivated vaccines were rolled out.

Compared with many new crown vaccines developed in Europe and the United States, the speed of data release for inactivated vaccines is obviously slower. The emergency use authorization of the two mRNA vaccines from European and American regulators was after the release of interim data from the phase III clinical trial, while the emergency use authorization of the inactivated vaccine was before the data was published. Among them, the data release of Sinopharm is weaker than Sinovac.

The aforementioned Sinopharm Beijing was reviewed by the WHO on April 29, and the results of the phase III trial of this vaccine were only made public at that time. However, the documents at the time clearly stated that more than 65 million people had been vaccinated with emergency use authorization:

The leadership of Sinopharm was dismissed, Sinovac stopped production, don't confuse these with the effectiveness and safety of vaccines

It is worth thinking about whether the data should be approved first and approved last, or whether the approval should be approved first and the data last. At the very least, the WHO's emergency use designation, regardless of which country produces the vaccine, is the data first, the certification last, and should be referenced.

As for the statements made by some company leaders in interviews with the media about the emergency authorization to inoculate millions of people without infection, without a single case of obvious adverse reactions, and 100% effective, these statements that are not in line with science and even seriously misleading can only be said to be a regrettable footnote in a period of history.

The leadership of Sinopharm was dismissed, Sinovac stopped production, don't confuse these with the effectiveness and safety of vaccines

Of course, this kind of remark cannot be used as evidence that the vaccine is safe and effective, but in the same way, the suspension of production and the violation of discipline and law by leaders do not mean that the vaccine is unsafe. Because the effectiveness and safety of vaccines are a scientific issue, not a public opinion issue, let alone a personnel issue, we must eventually return to science and rely on data to speak.

Finally, during the epidemic, I wrote a lot of popular science about the new crown vaccine, including the inactivated vaccines mainly used in China at that time, some of which disappeared for various reasons, and some of which are still there:

Is it reliable to say that the new crown vaccine has a 97% protection rate and no obvious side effects?

Is it unsafe because the vaccine is new? How do you know that the vaccine has no long-term safety risks?

The data of the Sinopharm vaccine is finally made public, and the WHO evaluation document is explained in detail

What questions does the latest domestic inactivated vaccine data from overseas answer?

Yes, more vaccine safety tracking data should be published, but vaccination is not related to leukemia

There is no evidence that the vaccine causes leukemia, but we know too little about the safety of the vaccine!

The results of Sinovac's clinical trial for minors were announced

A certain science popularization leader who has become a JWSL once attacked me for washing the floor of the XX vaccine because of my article, and some people accused me of not being optimistic about the XX vaccine and worshipping X. I laughed at these allegations to the contrary. Because I know that science is constantly advancing, and any research conclusions may be falsified in the future, I can't guarantee that every sentence will be wrong, but as long as I respect the data, speak with facts, and be fair and comfortable in people's hearts.

Looking back at most of these texts from two or three years ago, compared to that time, the world has long since changed, but in terms of overall scientific and fairness, I can still take out these articles generously and feel that they are not bad. More importantly, I have not misled anyone, let alone deceived anyone.

From Y Bo's Science Park A small science garden for biological dogs

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