zf2001 zf2001 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. zf2001vaccine descriptiontargetsars-cov-2vaccine typeprotein subunitclinical datatrade nameszifivaxroutes ofadministrationintramuscularatc codenonelegal statuslegal status full list of zifivax authorizations identifiersdrugbankdb15893 part of a series on thecovid-19 pandemicscientifically accurate atomic model of the external structure of sars-cov-2. each "ball" is an atom. covid-19 (disease) sars-cov-2 (virus) cases deaths timeline 2019 2020 january responses february responses march responses april responses may responses june responses july responses august responses september responses october responses november responses december 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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 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 full authorization emergency authorization allowed for travel