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"Now the epidemic has risen dramatically, very quickly, beyond the expectations of ordinary people, even public health experts
.
" Zeng Guang, former chief scientist of the epidemiology of disease control and control, mentioned
it at a public meeting a few days ago.
Zeng Guang analyzed that the reasons for this are many
.
In addition to the particularly high transmission rate of BF.
7 and BA5.
1, the main epidemic strains and the favorable climate in winter, "it also exposed that the third dose of the population took too long, and the antibody level (not enough).
.
.
"
.
.
"
Obviously, the immune barrier of Chinese society in the face of the new crown virus needs to be further strengthened
.
The introduction of the fourth dose plan can be regarded as an "emergency shot"
.
And after this wave of the epidemic, the new crown virus will continue to exist in
society.
Obviously, vaccination of the new crown vaccine will also become the norm every year, and after the fourth dose, there will be more shots
.
For a long time this year, especially from June to August, many people in the industry once believed that "the new crown vaccine market has become saturated"
.
Today, there is a renewed revival
of demand in this area.
-01-
-01-Several domestic vaccines announced that their trial data were "no worse than Pfizer mRNA vaccines"
Several domestic vaccines announced that their trial data were "no worse than Pfizer mRNA vaccines"The mRNA vaccine developed by the German company BioNTech is currently recognized as one of the best new crown vaccines in the
world.
In many countries and regions around the world, it is better known as the "Pfizer mRNA vaccine", and has been vaccinated by a large number of people
.
China's Fosun Pharma began to cooperate with BioNTech in March 2020, almost at the same time and in the same way
as Pfizer.
However, until now, the Fubitai vaccine cooperated by Fosun and BioNTech has only been vaccinated
in Hong Kong, Macao and Taiwan.
The timing of Chinese mainland likely approval remains a mystery
.
More than a month ago, during a visit to China, the German chancellor announced that Germans living in Chinese mainland would soon be able to be vaccinated with Fubitai and said that he had discussed with the Chinese side "the prospect of full approval of the vaccine in China"
.
Still, that seems too far away
.
So much so that when many cities recently entered the peak period of the new crown, many people went to Macau to fight Fubitai
.
At the same time, two Chinese vaccine companies have recently released data from head-to-head trials of their new crown vaccines and Pfizer mRNA vaccines, claiming that the effect is no worse
than the latter.
than the latter.
On December 14, 2022, Rico Biotech, which has been established for 11 years and was listed on the Hong Kong Stock Exchange in March this year, announced that in a head-to-head trial with Pfizer's mRNA vaccine, its new crown vaccine ReCOV showed "immunogenicity and non-inferiority"
.
In other words, the company announced that its coronavirus vaccine is no worse
than the Pfizer mRNA vaccine as a booster shot.
Liu Yong, the founder of this domestic vaccine company, holds a doctorate in pathogenic biology from Peking Union Medical College and completed postdoctoral research
at the Chinese CDC.
Previously, another domestic vaccine company, Shenzhou Cell, also did head-to-head clinical trials
with Pfizer mRNA vaccines.
Its head-to-head trial results showed that the company's two new crown vaccines were as effective or more effective
than the Pfizer mRNA vaccine.
However, the two companies' vaccines have slightly different trial designs
.
Rico's head-to-head trial belongs to II
Phase sequential intensive clinical trials in which participants are people
who have received two doses of inactivated vaccine.
The vast majority of China's basic population is an inactivated vaccine, and the trial was designed with the apparent goal of increasing the vaccine's competitiveness in the domestic booster market – more than 10 domestically produced vaccines have been approved
in Chinese mainland today.
who have received two doses of inactivated vaccine.
The trial, conducted in the Philippines, enrolled a total of 600 subjects and received Rico's ReCOV vaccine or Pfizer mRNA vaccine as a booster shot
.
The results showed that the levels of true virus neutralizing antibodies induced by ReCOV sequential reinforcement against Omicron variants BA.
5 and BA.
2 and prototype strains were significantly better than those in the mRNA vaccine group (the difference was statistically significant).
For the BA.
5 variant, the positive conversion rate (SCR) of ReCOV group, mRNA vaccine group and antibody was 92.
1% and 88.
4%, and the GMT of neutralizing antibody was 4387.
4 and 3100.
6, respectively, at 14 days of vaccination, which were significantly higher in the ReCOV group than in the mRNA vaccine group
.
The head-to-head trial of the new crown vaccine in China Cell includes people
who have received 2-3 doses of inactivated vaccine or Pfizer mRNA vaccine.
The interim
analysis of the Phase 3 trial has been published.
who have received 2-3 doses of inactivated vaccine or Pfizer mRNA vaccine.
The interim
analysis of the Phase 3 trial has been published.
According to the data released by Shenzhou Cell, its recently approved divalent seedlings for emergency use are developed
for the original strain and beta strain.
However, its neutralizing antibody titer against the BA.
1 strain was 1.
13 times that of the Pfizer mRNA vaccine, and its neutralizing antibody titer against the BA.
5 strain was 1.
02 times
higher.
In addition, another new crown vaccine that has not yet been approved by Shenzhou Cell is the quadrivalent vaccine, which targets the original strain, beta, delta and Omicron
.
In the face of Omicron BA.
1 and BA.
5, the antibody titers were 1.
58 times and 1.
35 times
that of Pfizer mRNA vaccines, respectively.
-02-
-02-All new adjuvants are used, and the storage conditions are relatively relaxed
All new adjuvants are used, and the storage conditions are relatively relaxedThe three vaccines mentioned above (including one approved and two unapproved) are all recombinant protein vaccines with more relaxed
storage conditions than mRNA vaccines.
vaccines.
According to Rico, its new crown vaccine can be stored at room temperature for at least 6 months and at least 24 months at 2-8 degrees, which is equivalent
to the storage requirements of traditional inactivated vaccines.
This is also the storage temperature
announced by Shenzhou Cells.
In contrast, mRNA vaccines such as Fubitai usually need to be stored in an environment of minus 60-80 degrees, and can only be stored for 1 month
in a 2-8 degree environment after thawing.
to storage requirements for conventional inactivated vaccines.
All three vaccines received good trial data, all associated
with the use of novel adjuvants.
with the use of novel adjuvants.
Shenzhou Cell previously announced that its approved new crown vaccine uses a new oil-in-water adjuvant
that significantly enhances the immunity of Th1 cells more than traditional aluminum adjuvants.
Rico Biotech said that its new crown vaccine uses its self-developed new adjuvant BFA03, which is benchmarked against GSK's adjuvant As03
.
"As an adjuvant of the GSK influenza A virus vaccine, AS03 has been used by hundreds of millions of people around the world, and it covers people of all ages and has a very good safety profile
.
Moreover, this adjuvant can quickly induce high titers of neutralizing antibodies, and the formulation is very stable and easy to mass produce
.
The relevant person in charge of the company said
.
At present, the bivalent seedlings of Shenzhou cells have been approved
.
Rico Biotech recently said that it is submitting a rolling product listing application
to the regulatory authorities.
In the special context of the rapid spread of the epidemic in recent days, this vaccine may have a relatively quick chance
of being approved.
-03-
-03-What's next?
What's next?Recently, with the rapid progress of the epidemic, the news of the approval of new vaccines has also come frequently
.
On September 4, CanSino's inhaled recombinant coronavirus vaccine was put into emergency use
as a booster shot.
On October 25, Shanghai announced that it was included in the option
of a third dose.
At the same time, the fourth vaccination program opened in Urumqi also included
it.
In early December, as the outbreak spread rapidly in Beijing and other places, four companies simultaneously announced that their coronavirus vaccines were included in emergency use
in China.
These include the 2-valent seedlings of Shenzhou cells mentioned above, as well as two recombinant protein vaccines developed by Clover Biologics and Chengdu Wesker/Sichuan University Huaxi, and Wantai Biologics' nasal spray virus vector vaccine
.
The introduction of the fourth dose of the vaccine program has re-expanded the industry's expectations for the field of new crown
vaccines.
According to the requirements of the program, at this stage, the fourth dose of vaccination targets include people at high risk of infection, elderly people over 60 years old, people with more serious underlying diseases and
immunocompromised.
vaccines.
Nowadays, there are also general residents who are willing to
get a fourth dose considering the long time since the first dose.
Chen Yuan (pseudonym), a 50-year-old citizen of Chongqing, was last vaccinated (for the third dose) on July 5, 2021, a year and a half ago
.
On November 11, 2022, the state issued the "On Further Optimizing the Prevention and Control Measures of the New Crown Pneumonia Epidemic
Notice on scientific and accurate prevention and control work", that is, twenty new regulations
on epidemic prevention.
Hearing the news, she predicted that the risk of infection would increase, and immediately went to the pharmacy to buy more than 900 yuan of various drugs, and wanted to immediately get a booster shot
.
The next day, Chen Yuan searched the Internet for a vaccine designated hospital near her home and called to ask if she could get a fourth dose
.
But the hospital clearly replied no, "the doctors have not yet given the fourth injection"
.
Chen Yuan said she was "so sad.
"
She said that there are many people like herself, who have been vaccinated for more than a year, and want to arrange a fourth dose
.
Obviously, the group of the fourth dose will be further expanded
.
In the past few days, several cities such as Haikou in Hainan and Shangrao in Jiangxi have opened the fourth dose plan for people over 18 years old, "willing to receive everything"
.
.
In the past few days, several cities such as Haikou in Hainan and Shangrao in Jiangxi have opened the fourth dose plan for people over 18 years old, "willing to receive everything"
.
Since the new crown virus will continue to mutate, the new crown vaccine may be vaccinated once a year like the flu vaccine in
the future.
For Chinese vaccine companies, this is both a challenge and an opportunity
.
In the second half of the new crown vaccine, perhaps we will further see the maturity of China's vaccine industry technology and the increasingly complete industrial system
.
