biology

ZF2001

ZF2001 is a biology topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand ZF2001 rather than just read about it. In short: ZF2001, trade-named Zifivax or ZF-UZ-VAC-2001, is an adjuvanted protein subunit COVID-19 vaccine developed by Anhui Zhifei Longcom in collaboration with the Institute of Microbiology at the Chinese Academy of Sciences. The vaccine candidate is in Phase III trials with 29,000 participants in China, Ecuador, Malaysia, Pakistan, and Uzbekistan.

Key takeaways

ZF2001 belongs to biology; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect ZF2001 to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of ZF2001 from memory before moving on to harder problems.

Reference excerpt

ZF2001, trade-named Zifivax or ZF-UZ-VAC-2001, is an adjuvanted protein subunit COVID-19 vaccine developed by Anhui Zhifei Longcom in collaboration with the Institute of Microbiology at the Chinese Academy of Sciences. The vaccine candidate is in Phase III trials with 29,000 participants in China, Ecuador, Malaysia, Pakistan, and Uzbekistan. ZF2001 employs technology similar to other protein-based vaccines in Phase III trials from Novavax, Vector Institute, and Medicago. ZF2001 was first approved for use in Uzbekistan and later China. Production capacity is expected to be one billion doses a year in China and 200 million in Uzbekistan. By July, 100 million doses had been administered in China and Uzbekistan.

Medical uses It is administered in three doses over a period of two months.

Efficacy In August 2021, preliminary data from a phase III study with 28,500 participants indicated an overall efficacy of 82% against disease of any severity. Efficacy was 93% against the Alpha variant and 78% against the Delta variant. In July 2021, lab studies showed ZF2001 retained neutralizing effects against B.1.429 (Epsilon), B.1.351(Beta), P.1(Gamma), B.1.525(Eta), B.1.617.1(Kappa), the neutralizing titers decreased ranging from 1.1 fold to 2.1 fold, but the neutralizing efficacy were still good.

Manufacturing According to industry experts, production for this kind of vaccine is stable and reliable, and easier to achieve large-scale industrial production at home and overseas. However it was noted it can be very inconvenient for people to come back for a second and third dose. Subunit vaccines are delivered alongside adjuvants and booster doses may be required. The company's vaccine manufacturing facility was put into use in September. In February 2021, management said the company had an annual production capacity of 1 billion doses. In July 2021, an agreement was reached to produce the vaccine in Uzbekistan starting with 10 million doses a month and eventually 200 million doses a year.

History

Clinical trials

Phase I and II trials and results In June 2020, Longcom began a double-blind, randomized, placebo parallel controlled Phase I trial with 50 participants aged 18–59 in Chongqing divided into low-dose, high-dose, and placebo groups. In July, Longcom began a randomized, double-blind, placebo-controlled Phase II trial with 900 participants aged 18–59 in Changsha, Hunan divided into low-dose, high-dose, and placebo groups. In August, an additional Phase II trial was launched with 50 participants aged 60 and above. In Phase II results published in The Lancet, on the two-dose schedule, seroconversion rates of neutralizing antibodies after the second dose were 76% (114 of 150 participants) in a 25 μg group and 72% (108 of 150) in a 50 μg group. On the three-dose schedule, seroconversion rate of neutralizing antibodies after the third dose were 97% (143 of 148 participants) in the 25 μg group and 93% (138 of 148) in the 50 μg group. 7 to 14 days after the administration of the third dose, the GMTs of neutralizing antibodies reached levels that were significantly higher than observed in human convalescent serum of recovering COVID-19 patients, especially in the 25 μg group.

Phase III trials In December 2020, Longcom began enrollment of a Phase III randomized, double-blind, placebo-controlled clinical trial for 29,000 participants, including 750 participants between 18-59 and 250 participants 60 and older in China and 21,000 participants between 18-59 and 7,000 participants 60 and older outside China. In December 2020, Malaysia's MyEG announced it would conduct Phase III trials. If the trials were successful, MyEG would be the sole distributor of ZF2001 in Malaysia for 3 years. In December 2020, Uzbekistan began a year-long Phase III trial of ZF2001 with 5,000 volunteers between 18 and 59. In December 2020, Ecuador's Minister of Health, Juan Carlos Zevallos announced Phase III trials would involve between 5,000 and 8,000 volunteers. In February 2021, Pakistan's Drug Regulatory Authority (DRAP) approved Phase III trials with approximately 10,000 participants to be conducted at UHS Lahore, National Defense Hospital, and Agha Khan Hospital. The vaccine is also being trialed in Indonesia.

Children and adolescents trial In July 2021, Longcom began a randomized, blinded, placebo-controlled phase I with 75 participants aged 3–17. In November 2021, Longcom began a phase II with 400 participants aged 3–17.

Authorizations

On 1 March 2021, Uzbekistan granted approval for ZF2001 (under tradename ZF-UZ-VAC 2001) after having taken part in the Phase III trials. In March, Uzbekistan received 1 million doses and started vaccinations in April. By June, a total of 6.5 million doses had been delivered. In March 2021, China approved of ZF2001 for emergency use after being approved by Uzbekistan earlier in the month. In June 2021, Malaysia's MyEG signed a letter of intent to purchase 10 million doses of the vaccine. On 7 September, the National Agency of Drug and Food Control of Indonesia (BPOM) published the emergency use authorization for Zifivax. On 10 January 2022, the National Agency of Drug and Food Control of Indonesia (BPOM) published the emergency use authorization for Zifivax as Booster for Sinovac.

Research As described in Cell, the CoV spike receptor-binding domain (RBD) is an attractive vaccine target for coronaviruses but is constrained by limited immunogenicity, however a dimeric form of MERS-CoV RBD offers greater protection. The RBD-dimer significantly increases neutralizing antibodies compared to a conventional monomeric form and protected mice against MERS-CoV infection. CoV RBD-dimer have been produced at high yields in pilot scale production. Rather than injecting a whole virus, subunit vaccines contains virus particles specially selected to stimulate an immune response. Because the fragments cannot cause disease, subunit vaccines are considered very safe. Subunit vaccines in widespread use include the Hepatitis B vaccine and Pertussis vaccine. However, as only a few viral components are included in the vaccine which does not display the full complexity of the virus, their efficacy may be limited.

References

External links

Illustrations

Worked examples

Example 1 — a first encounter with ZF2001

Start with the simplest possible case. Write down what ZF2001 claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In biology, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to ZF2001 before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about ZF2001 ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of ZF2001

In research: ZF2001 appears in biology research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses ZF2001 in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: ZF2001 is common in secondary-school and first-year university syllabi. It links to neighbouring topics Chinese COVID-19 vaccines, Drugs not assigned an ATC code, Products introduced in 2020, so understanding it makes those chapters shorter.
In everyday life: Look for ZF2001 outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study ZF2001 in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what ZF2001 means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain ZF2001 out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is ZF2001 in simple terms?

Why does ZF2001 matter?

Because it connects several biology ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study ZF2001?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on ZF2001.