Will Vaccine Bottle Shortages Affect Vaccine Production? Annual Output of 8 Billion: Can the “Bottleneck” Be Overcome?

It has been reported recently that even if covid-19 vaccine does come on the market in the near future, it will not be possible to produce one vaccine per person, even if there is enough of it, because there is a serious shortage of glass vials needed for global storage of the vaccine.On May 17, the China vaccine industry association issued a statement in response, saying that China’s annual production of vaccine bottles can reach at least 8 billion, which can meet the needs of covid-19 vaccine production, and the “bottleneck” can be broken.

Official website of China vaccine industry association

According to the China vaccine industry association, based on the vaccine bottle industry observation and industry data, after communication and demonstration with several benchmark enterprises, it is believed that China has the industrial basis for the production of high-quality vaccine bottles. According to incomplete statistics, the annual output can reach at least 8 billion bottles, which can meet the production needs of covid-19 vaccine.

According to the introduction, the special requirements of the vaccine for the selection of borosilicate glass material, mainly controlled injection bottles (commonly known as syringes) and prefilled sealed syringes.Currently, there are more than 60 packaging manufacturers in China, among which ningbo zhengli and shuangfeng greensheim are the major manufacturers of vaccine injection bottles, and shandong weigao, ningbo zhengli, shandong pharmaceutical, BD and other manufacturers of pre-filling and sealing syringes.

According to the China vaccine industry association, based on the production capacity of the above-mentioned enterprises, according to preliminary estimates, the annual output of vaccine bottles in China could reach at least 8 billion.According to the global progress of covid-19 vaccine development, vaccine bottle manufacturers currently have sufficient preparation time and production capacity base. As long as covid-19 vaccine development is successful and the form and specifications of the packaged products are determined, vaccine bottle manufacturers can quickly release production capacity and meet the market demand in an orderly manner.

It is worth noting that the selection of vaccine packaging materials is a very rigorous process.From the audit of qualified packaging material suppliers to the study of compatibility between drugs and packaging material, it involves the investigation of the comprehensive capacity of packaging material manufacturers.The stability test of the selected packaging material of the vaccine requires a long period of validation, which usually takes about 2-3 years, depending on the expiry date of the drug.Such high standards ensure the safety and reliability of the vaccine packaging materials.

At present, a number of vaccine bottle manufacturing enterprises in China have contacted with the vaccine r&d units of xunguan to understand the production requirements of vaccine bottles in advance, reserve the raw materials, and arrange production according to the vaccine r&d schedule to ensure the production needs of vaccines.

Why Is COVID-19 Vaccine Development Slow?

The covid-19 epidemic has spread around the world, infecting more than 4 million people and killing more than 300,000, posing a new threat to human health as a new member of the infectious family.The novel coronavirus vaccine is still in the market, which makes people wonder why the development of novel coronavirus vaccine is so slow.

In fact, the novel coronavirus vaccine was developed at a speed beyond imagination.As we all know, vaccine development is a time-consuming, high-risk and high-investment task, which generally involves three steps: pre-clinical research, human clinical trials, and formal promotion and application.

Under normal circumstances, traditional vaccine development can be as short as three to five years, or as long as more than 10 years, depending on the type of virus and the path of technology used.It is expected to take 12 to 18 months for the covid-19 vaccine to be on the market. Compared with traditional vaccines, its development time has been greatly shortened.A vaccine expert told China news service: “we can understand the public’s desire for the vaccine, but we should face up to the objective laws of vaccine development.”

Developing a vaccine will not be easy.In the case of the SARS(severe acute respiratory syndrome) outbreak in 2003, it took researchers 20 months to develop a vaccine that could be tested on humans, but the epidemic was already under control and large-scale clinical trials could not be carried out.This has led to the fact that, 17 years after the SARS outbreak, no vaccine has yet been produced to prevent the SARS virus.A similar situation occurred in MERS (Middle East respiratory syndrome) outbreak in 2013. Until now, researchers have not developed a vaccine or a specific drug for MERS.

Since the outbreak of covid-19, China has developed covid-19 vaccine according to five technical routes: inactivated vaccine, genetic engineering subunit vaccine, recombinant novel coronavirus vaccine (adenovirus vector), attenuated influenza virus vector vaccine and nucleic acid vaccine. At least more than 15 enterprises and research institutions have carried out research on vaccine development.At present, there is a recombinant adenovirus vector vaccine and four inactivated vaccines, which have been successively approved by the state food and drug administration. Phase I and phase ii combined clinical trials were carried out, and a total of 2,575 volunteers were vaccinated.

Globally, as of May 11, 110 covid-19 vaccines in development have been documented on the who website, of which eight have entered clinical trials.Four are from China, three are from the United States and one is from the United Kingdom.Among them, the novel coronavirus vaccine developed by Chen wei, an academician of the Chinese academy of engineering and a researcher of the academy of military sciences, started phase ii clinical trial on April 12, becoming the world’s earliest novel coronavirus vaccine to enter phase ii clinical trial.

On May 15, zeng yixin, deputy director of China’s national health commission, said at a press conference held by the state council information office that China’s covid-19 vaccine research and development is progressing smoothly, and some projects are expected to complete phase ii clinical trials by July.

“The second phase will be followed by the third phase.The second phase is mainly to test the protective effect and initial safety of the vaccine. The third phase requires a larger sample size and higher requirements.”Wang guiqiang, director of the department of infectious diseases at Peking University’s first hospital.

In addition to the long development process, the safety and efficacy of the covid-19 vaccine is also an important reason for the delay in its release.

Currently, there is no commercially available vaccine against coronavirus in the world, and the lack of experience and risk assessment makes covid-19 a challenge for researchers.Zhang xinmin, director of the biological center of the ministry of science and technology, previously stressed that the safety of vaccines, as a special product for healthy people, is the first priority.“Vaccine development must follow scientific rules and strict regulations, and researchers must be given a certain amount of time.”

The first step in developing a new vaccine is to extract a strain of the virus, which has been done at a staggering pace in several research centers in China, according to the report.But this is only the beginning of vaccine development, which will include culturing strains, modifying the virus, attenuating it, animal testing and human clinical trials.

Wang peiyu, deputy dean of the school of public health at Peking University, said that in order to stimulate the production of antibodies, the vaccine must be consistent with the virus in many aspects, but “very virus-like” vaccines into the human body, whether it will cause side effects and how safe it is to be clear.Therefore, to test the safety and efficacy of vaccines, clinical trials are particularly time-consuming.

So when will the covid-19 vaccine actually hit the market?

Gao fu, director of the Chinese center for disease control and prevention, said China may have a vaccine available in September that can be used in emergencies and could develop a vaccine for healthy people by early next year.

Several research and development teams in the United States and Europe are also aiming for emergency authorization this fall, with the vaccine likely to be available in September.

It will be more than three months from now until September, when scientists will have to find enough samples to complete phase ii and iii trials to confirm their safety.Lu shan, former President of the international vaccine society and a professor at the university of Massachusetts medical school in the United States, said that the preparation of vaccines faces many practical problems, such as the traditional phase iii clinical trials that need to target the target population, the huge investment in vaccine research and development, and the complicated discussion process among experts and institutions.When you get a vaccine depends on the balance of four forces: science, technology, regulatory agencies, and social need.

Vaccine experts also stressed that the quality of vaccines remains the top priority, and that avoiding “unresponsive immunity” is the key to vaccine development.In this case, the availability of a covid-19 vaccine will have to wait.

2,575 Volunteers Vaccinated with Novel Coronavirus Vaccine: No Significant Adverse Reactions Reported

At present, one recombinant adenovirus vector vaccine and four inactivated vaccine projects have been successively approved by the state food and drug administration to carry out clinical trials, and no major adverse reactions have been reported so far.If all goes well, phase ii trials will be completed in July.

According to zeng yixin, a recombinant adenovirus vector vaccine and four inactivated vaccines are currently undergoing phase I and phase ii clinical trials in China.So far, a total of 2,575 volunteers have been vaccinated in phase I and phase ii clinical trials.

As of May 13, a total of 2,575 volunteers had been vaccinated in the five vaccination programs, it said.A total of 539 volunteers have been vaccinated in phase I clinical trials, and some have obtained preliminary data on safety and protective antibody production.The phase ii clinical trial has inoculated a total of 2036 volunteers, and is in the process of completing all second or third shots, as well as monitoring and evaluating their safety and efficacy.

Zeng said vaccine research and development in other technical routes is also progressing smoothly and orderly.“It is expected that another project will be approved to enter the clinical trial stage by the state food and drug administration from June.”Since the outbreak of covid-19, the joint prevention and control mechanism of the state council has established a research team led by the ministry of science and technology.The scientific research team set up a special vaccine class, which was responsible for organizing, coordinating and serving various units to promote vaccine research and development.So far, things are going well.

Previously, it was reported that as of May 11, 110 covid-19 vaccines under development had been registered on the who website, of which eight have entered clinical trials.Among them, the adenovirus vector vaccine of the academy of military sciences and the academy of military medicine has carried out phase ii clinical trials.Sinopharm group China biological wuhan institute of biological products and Beijing kexingzhong biological products technology co., ltd. jointly developed the inactivated vaccine with the relevant scientific research institutions, and obtained the combined clinical trial license of phase I and phase ii.The new coronavirus inactivated vaccine developed by the Beijing institute of biological products of China was approved for clinical trial by the state food and drug administration, and the clinical trial was also launched.

In response to

Expanding the scope of nucleic acid testing in wuhan is an important guarantee for the prevention and control of the epidemic

The city of wuhan, hubei province, will carry out nucleic acid tests on its citizens in an orderly manner to determine the number of asymptomatic infections.Zeng yixin, deputy director of the national health commission, said the move is an important guarantee for the prevention and control of covid-19 on a regular basis.

Zeng said the main purpose of the move is to further clarify the scope of the epidemic.Expanding the scope of testing is an important measure to implement the “four early detection” measures, and also an important guarantee for coordinating the resumption of work, production and school, and the prevention and control of the epidemic on a regular basis.

He said that on the basis of a comprehensive scientific assessment of the risk and detection capacity of the epidemic, expanding the scope of nucleic acid testing will not only be conducive to accurate prevention and control, protect people’s health, but also contribute to the rational flow of people and promote the full restoration of social, economic and living order.

To clarify

“Deny who access to the wuhan laboratory” is not true

China attaches great importance to its cooperation with the world health organization (who), li mingzhu, inspector general of the international cooperation department of the national health commission (NHC), said at a press conference of the who on Monday.

Mingzhu said that on January 20, 2011, China hosted a who team to visit wuhan, hubei province. The team visited medical and health institutions, including laboratories, and had in-depth exchanges with experts in hubei.February 16 to 24, received China – the world health organization expert group, to Beijing, sichuan, guangdong and hubei wuhan, comprehensive and in-depth research epidemic situation, prevention and control measures, medical treatment, scientific research, etc., they also to China and all countries in the world epidemic prevention and control are very valuable and constructive Suggestions are put forward.

“Who has never made a request to visit a particular laboratory, so it is not true to say that the who is denied access to the wuhan laboratory.”Li said that since the outbreak of the epidemic, China has been sharing information about the epidemic with the who and the international community in an open, transparent and responsible manner.

Can Viruses Spread Through Clothes?

Since May 7, 15 new local confirmed cases have been reported in shulan city, jilin province.On May 10, a new local confirmed case was reported in shenyang, liaoning province. The case took a high-speed train from jilin city to shenyang on May 5.Since May 9, six new cases have been confirmed in wuhan, hubei province, all from the same community.

What do you think of these new indigenous cases?How should the prevention and control of the epidemic be carried out on a regular basis?“News 1 + 1” bai yansong joins wu zunyou, chief epidemiologist of China center for disease control and prevention, for your interpretation.

Covid-19 is much more complex than SARS

Sporadic reports of cases were expected

Wu zunyou: this kind of situation is expected. When we first did news 1 + 1 on January 30, I told you that the tail would be quite long, and now it has been confirmed that the tail will be quite long.When we see sporadic case reports every day, especially from people who have tested positive, we know that sporadic cases will occur.

When there were zero cases in the SARS epidemic in 2003, there were no new reported cases. Many people kept the history or experience of the SARS epidemic in mind. When there were “zero” cases in covid-19, we also hoped that we could do the same.

Covid-19 is far more complex than SARS, and our understanding of it is still very limited. It is much more complex and difficult than SARS in terms of its transmission mode, prevention and control difficulties and clinical manifestations, which has further improved our understanding of it.

The first confirmed case of a laundryman in jilin shulan is not necessarily the source

Wu zunyou: after the outbreak of the epidemic, the epidemiological investigation is trying to find the source. It is really difficult to find the source.Yesterday, the Chinese center for disease control and prevention also sent professionals to shulan to assist in the investigation. As far as the current situation is concerned, it is still difficult to judge whether the patient diagnosed for the first time is the original patient or not.

The female comrade is a washerwoman, is a kind of speculation, she may be the source of the outbreak of a clustering, but also there is another possibility, is also a real source has not yet found, may be the main source for the spread of this, all of these need more epidemiological investigations, or biological methods are needed to analyze speculation.

Incubation period of another possibility, that is, some patients may be the incubation period is longer than the laundryman, he may infect the laundryman, and the laundryman incubation period is short, may be two or three days to disease, and the sources of real patients may after infection, seven or eight genius, the incubation period is contagious.If it’s like this, it’s very difficult to tell who passed it to whom.

Is the confirmed patient of jilin shulan related to the imported patient from Russia?

Zunyou wu: need to do right now, is to this group of viruses gathered in STD patients and from Russia’s entry into the virus gene sequence analysis of patients, their homologous, if very consistent homology, the presumption can is related with the Russian immigration cases, specific happened relationship, it is not good.

Jilin shulan confirmed laundry workers infected by clothes, is it possible?

Wu zun friends: a few days ago, there was a research report, the concentrations of the virus is about the air, the researchers of hospital patients and doctors to replace isolation ward air pollution areas, and clean the air sampling, found in medical staff to replace isolation clothing space, the air instead of higher levels of virus, that is to say, if the staff inside the room, his clothing may touch the virus, take off in the process of air have higher levels of the virus.So does this suggest something similar in the cluster cases of shulan?These also provide a new way for us to analyze.

Bai yansong: there is a folk belief that the case in shulan has now been identified as a laundryman from the public security bureau. From April 8 to 30, the public security bureau involved picking up people (from Russia). Is it possible that the laundryman was infected in the process of making and picking up the clothes of the public security bureau?

Wu zunyou: it’s possible. 

Confirmed cases from jilin to shenyang suggest:

Take protective measures when using a closed vehicle

Wu zunyou: when we travel, we are likely to encounter infected patients, or patients in the incubation period. It also reminds us that we should stick to the protective measures in the closed traffic environment.For such a case, there will be many infected people along the way. It is also very difficult for us to fully investigate close contacts. There may be missing close contacts.

Regular epidemic prevention does not mean the epidemic is over

Routine precautions must be taken

Wu zunyou: people may have a different understanding of normalization. Many people understand that normalization is the end of the epidemic.Is it possible to go back to the way we were before the covid-19 outbreak?Not really.The so-called norm, is in the case of us to take protective measures, can return to normal life, work, basically in normal circumstances, or in accordance with the requirements of the prevention and control guidelines, in the place where people gather, in the airtight place, will keep on taking protective measures, especially when we are in the process of travel, must pay attention to protection.

The first confirmed case in wuhan’s east west lake community

Come on from march to may why so long?

Bai yansong: wuhan announced a confirmed case of community infection the day before yesterday.But this case, had the symptom in March, afterwards the symptom disappeared, until now attack diagnose, how to analyze the hair history that he has lasted nearly more than two months?

Wu zunyou: we also noticed this patient. In fact, there are more than one such case in wuhan. Some may have a course of 30 days, 40 days or even 50 days.For the recovery of covid-19 patients, it mainly depends on the patient’s immunity and resistance. If the patient has a strong immunity, he can get rid of the virology in a short time. If the patient’s resistance is weak, he cannot get rid of the virus, so the virus may stay in the body for a long time.

This suggests that when people are old and have low immunity, the course of the disease may be long and may be repeated, which is a difference between covid-19 and SARS and other diseases.An analysis of the disease spectrum in different age groups shows that the younger people, especially children, have a higher proportion of asymptomatic infections, while the younger people have milder symptoms, all of which point to the presentation of symptoms and the speed of recovery, both of which are related to immunity.

Wuhan 6 new cases from the same community to give us what reminder?

Wu zunyou: as long as there is no real “zero clearance” in the community, or there is a positive test in the community (there is a risk).Has quite part of test positive, symptoms of asymptomatic infections is very light, he can’t feel, that these are infectious, he infected patients, infected people may appear symptoms, also could not symptoms, whether or not appear symptoms, he still has the risk of transmission to others, the community or to be vigilant, to strengthen prevention.

Nucleic acid testing is mainly carried out in key areas and populations

Everybody doesn’t have to do it

Net friend: the 5 new confirmed cases in wuhan yesterday all came from the changqing street community. Does that mean we need to screen asymptomatic infected people?Is nucleic acid testing needed to screen the entire population for asymptomatic infections?

Wu zunyou: mass screening nucleic acid test is not everyone to do?Actually also unnecessary, basically be in key area, key crowd.As this netizen said just now, such communities still need to conduct large-scale screening. In those communities without cases, it is not necessary to conduct screening for everyone, but to conduct large-scale screening for key positions, key groups and people in key communities.

Confirmed cases of extra-long illness in wuhan suggest the cunning of the covid-19 virus

The way it coexists with humans is impossible to fathom

Wu zunyou: our understanding of the covid-19 virus is still very limited, and this limitation makes it impossible for us to determine, or determine, how it will co-exist with humans in the future.For now, it’s not going to go away as quickly as SARS did, and it’s not clear how long it’s going to co-exist with humans, or whether it’s going to co-exist with us in an epidemic form.On the other hand, the clinical manifestations of covid-19 are also very special. The case of the man in his 80s you mentioned just now also shows its clinical manifestations are very special. All of these are the continuous improvement of our understanding of the covid-19 virus.

Sporadic cases will no longer cause epidemics of a certain scale

Wu zunyou: I don’t think there will be a small peak.After more than three months of efforts to successfully control covid-19, we have achieved, or at least gained, a lot of experience that will prevent the emergence of sporadic cases from causing a pandemic of a certain scale.Because of our surveillance system, as long as cases are detected, checked and tracked in a timely manner, the epidemic can be put out very quickly and there should be no small epidemic peak.

Net friend: weather more and more hot a lot of people mask wear not to do?

Wu zunyou: the issue of masks is really a very complicated and scientific one. In open areas, in families, you can not wear masks.Masks should be worn in public places, especially in confined environments, even when it is hot, and there is no evidence yet that the spread of covid-19 does not occur when the weather is hot.For such data, the weather is not so hot that we can’t wear masks at present. We still need to overcome some difficulties and persist in wearing masks. We can’t remove masks completely before we have definite evidence.

Will the inaccuracy of temperature measuring gun affect the prevention and control effect?

Wu zunyou: we are not the only one who relies on temperature measurement. We also have symptom monitoring. Some patients have fever, some do not have fever at the beginning, and some have cough and fatigue.

Patients with covid-19 are contagious when they do not exhibit clinical symptoms

Protective measures should not be abandoned when people gather

Wu zunyou: what I want to remind you is that covid-19 is highly contagious, especially when the patient has not yet developed clinical symptoms. The virus detoxification rule of the infected person can be contagious one or two days before the patient has clinical symptoms.For all of you, the fight against covid-19 is still going to have to be sustained, and you’re still going to have to wear masks in places where people are gathered, and you’re not going to give up. 

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