After the COVID-19 epidemic afflicted mankind for seven months, there is finally a COVID-19 vaccine on this earth.

From Russia, namedSatellite 5 (Sputnik V)The Russian Ministry of Health has approved.

Putin personally announced the news yesterday, adding that one of his daughters had been vaccinated with the vaccine and had a slight fever, but he felt good overall and had antibodies in his body.

However, Putin was happy, and the outside world was completely confused when he saw the news:

Will you approve it after you finish the clinical trial?!

Prior to approval, only76人Participated in the clinical trial in two waves.

According to the standards of the National Institute of Allergy and Infectious Diseases, a phase I clinical trial of less than 100 people is generally considered.

According to the textbook standard of Pharmacology of the people's Health Publishing House, 100,200 people should participate in the phase II clinical trial.

From this point of view, Russia is almost jumping dragon posture, at least skipped the third phase of the clinical trial, or even did not do a good job in the second phase, only conducted a phase of clinical trial, directly approved.

Yes, they approve it before they do clinical trials.

Now, Russia and the whole world are confused, and even the two top journals in the scientific community, Nature and Science, are complaining:

In a report in the Washington Post, government officials in charge of Russian vaccination funds said that Russia would continue to conduct phase III clinical trials.

In other words, it is approved and used first, and whether it is safe or not, the fighting nation is so brave.

But even more frightening, the official said, Russia has received applications for more than 1 billion doses of vaccine from more than 20 countries and is preparing to produce more than 500 million doses a year in five countries.

Russia is not only pushing its own limits, but also preparing to play the game of the brave with 1 billion people around the world.

This vaccine, called satellite, is not really launching a satellite, is it?

Russian self-developed adenovirus vaccine

The vaccine, developed by the Gamal National Research Center for Epidemiology and Microbiology, was registered by the Russian Ministry of Health on August 11 and became the first registered novel coronavirus vaccine on the market.

For them, the vaccine is equivalent to creating a "satellite moment" for the entire global vaccine research community.

Just as 63 years ago, in 1957, the Soviet Union launched its first man-made satellite, Sputnik-I, to strengthen space research around the world.

So this time, the meaning is the same, so it is named "Sputnik V".

Like the previously reported vaccine in phase 3 clinical trials, this vaccine belongs to the "adenovirus vector vaccine".

The structural information encoding S protein (also known as spike protein) was embedded into the adenovirus vector. The vector itself is a virus with no reproductive gene, just a porter transporting S protein.

But unlike other vector vaccines, they will passTwice inoculationThe way to use itTwo vector vaccines.

The first inoculation is the AD26 vector, the second inoculation is the AD5 vector, both are commonly used adenovirus vectors, the second inoculation to play a strengthening role.

The interval between the two vaccinations was 21 days.

Before starting clinical trials, the vaccine goes through various stages of "preclinical efficacy" and "safety trials", including trials on different types of experimental animals, including two species of primates, according to the R & D center's website.

In early August, the vaccine had completed a phase 2 clinical trial. The registration documents for the vaccine are now available on the official website of the Russian Ministry of Health:

But surprisingly, the registration document was issued on Aug. 11, and the phase III clinical trial began on Aug. 12 in several Middle Eastern countries, including Russia, the United Arab Emirates and Saudi Arabia, and Latin American countries such as Brazil and Mexico.

This order is reversed.

How do you do clinical trials in Russia?

In the information on vaccine trials that have been made public, 38 volunteers were selected in each of the two trials experienced by Sputnik V.

The volunteers need to meet some routine conditions, such as no contact with COVID-19 patients within 14 days, their own health, no major basic diseases and other acute diseases.

The selected volunteers will be vaccinated with two different components of adenovirus:

Component 1:rAd26 vaccine, a recombinant vector vaccine based on human adenovirus type 26, contains SARS-CoV-2 S protein gene.

Component 2:rAd5 vaccine, a recombinant vector vaccine based on human adenovirus type 5, contains SARS-CoV-2 S protein gene.

The specific experiment is divided into two stages:

The first stage

The first group, nine volunteers, will be given a full therapeutic dose.Component 1A single dose of immunization was given intramuscularly.

The second group, the other nine volunteers, will be given a full therapeutic dose.Component 2A single dose of immunization was given intramuscularly.

After vaccination, safety will be monitored for 5 consecutive days. Based on the results of the safety assessment, the researchers decided whether to conduct the second phase of the study on the fifth day.

The second phase will include the remaining 20 volunteers who will be vaccinated according to the upgrade plan: component 1 on the first day and component 2 on the 21st day.

Clinical observation was carried out on the 7th, 14th, 28th and 42nd day after injection, and the safety of the vaccine was confirmed by telephone playback on the 90th and 180th day.

In fact, according to the public experimental plan, the second phase of experimental vaccination will begin on June 17 and end on August 15 at the earliest.

So strictly speaking, there is no definite experimental conclusion about the safety of Sputnik V at present.

This is why the outside world questioned after President Putin announced the news.

"Crazy Russians"

There are not only scientists from Europe and the United States, but also professionals within Russia who question this "man-made satellite" of Russia.

The focus of everyone's criticism is that the vaccine has not been fully tested for safety and effectiveness at all.

The World Health Organization, which tracks COVID-19 's vaccine development, lists Sputnik V as the first of only three major clinical trials.

In general, phase I clinical trials of vaccines are small (usually involving only a few dozen people) and only assess the safety of candidates receiving the vaccine.

Phase II trials may involve hundreds of people to further study the safety, clinical dose and immune response of the vaccine-triggered immune response. The results of phase II can generally be used as a reference for the effectiveness of the vaccine, but it is still not certain that it is safe and effective.

Finally, there is a phase III clinical trial, which involves thousands of people and assesses whether the vaccine can be used clinically.

So what stage is Sputnik V at?

Today, phase III clinical trials of the vaccine have only begun, according to the official website.

Svetlana Zavidova, head of the Russian Association of Clinical Research organizations, yesterday called on the Ministry of Health to postpone the registration of the vaccine until appropriate efficacy trials are completed.

She said accelerated registration is unlikely to give Russia the lead in the vaccine race, but only puts Russian citizens at unnecessary risk.

The doubts of foreign media and European and American experts are even more acute.

Ars Technica reported that from the very little information released by Sputnik V, the first phase of the vaccine began less than two months ago, recruiting 38 volunteers each, a group of "crazy Russians."Not to mention the third phase of the experiment, the second phase of the experiment may not even be completed.。

In addition to security, the effectiveness of Sputnik V is also called into question.

The adenovirus vector used by Sputnik V, a virus that is harmless to humans, may have been carried by about 80% of the population in some areas, and it is doubtful whether the vaccine can cause an effective immune response when injected into the body.

Peter Hotez, a vaccine scientist at Baylor School of Medicine in Houston, Texas, believes that Russia may skip the verification of the safety and effectiveness of the vaccine, which worries the vaccine research community that if there are any hidden dangers and errors in the Russian vaccine, it could damage the world.

Francois Balu, a geneticist at the School of Vaccines at the University of London, said bluntly: "it was a reckless and stupid decision." Mass vaccination with vaccines that have not been properly tested is immoral. "

Russia's "work fast" vaccine progress is obviously not in line with the general rules, so where are the vaccines in other parts of the world and countries?

China takes the lead in formal vaccine research and development

Although Russia has taken a big step forward, the good news is that the vast majority of countries on earth are still following the scientific, step-by-step testing of vaccines.

According to the latest information published on World Health Organization (WHO) 's official website as of Aug. 10, 28 vaccines worldwide have entered clinical trials, and another 139 are under study but have not yet entered clinical trials.

Of the six vaccines that are already in phase III clinical trials, three are from China, one is Sino-foreign cooperation, and one has been contracted for production with Chinese companies.

The six vaccines are:

1. The vaccine jointly conducted by pharmaceutical giant AstraZeneca PLC and Oxford University entered phase III clinical trials early last month. Kangtai Biology, a Chinese company, announced on August 6th that it had signed a contract with AstraZeneca PLC to promote the clinical development, production and commercialization of this vaccine in the Chinese market.

2. The vaccine developed by Sinovac Biotech in Beijing has begun phase III clinical trials in Indonesia and Brazil, and will also be conducted in Bangladesh next month.

3. The vaccine of Wuhan Institute of Biological products of Sinopharmaceutical Group has also entered the phase III clinical trial.

4. The vaccine jointly developed by the Beijing Institute of Biological products of the National Pharmaceutical Group and the Institute for virus Disease Prevention and Control of the Chinese Center for Disease Control and Prevention completed the first two clinical trials and launched the third phase of clinical trials at the end of June.

And just last week, their COVID-19 vaccine production workshop also passed the national inspection, and already has the production conditions.

5. The vaccine developed by US company Modena and the National Institute of Allergy and Infectious Diseases began phase III trials in July, and Modena has reached an agreement with the US government for 1.525 billion US dollars to purchase 100 million doses of COVID-19 vaccine after approval.

6. The vaccine jointly developed by German biotech company BioNTech, Shanghai Shanghai Fosun Pharmaceutical and Pfizer Inc has also entered the third phase of the trial, and the trial results may be obtained by October.

These most promising first-tier vaccines, with the exception of the fifth Modena above, are related to Chinese companies.