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Zf2001

The meaning of «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.[1][2] The vaccine candidate is in Phase III trials with 29,000 participants in China, Ecuador, Malaysia, Pakistan, and Uzbekistan.[3][4]

ZF2001 employs technology similar to other protein-based vaccines in Phase III trials from Novavax, Vector Institute, and Medicago.[5]

ZF2001 was first approved for use in Uzbekistan and later China.[6][7] Production capacity is expected to be one billion doses a year in China[8] and 200 million in Uzbekistan.[9] By July, 100 million doses had been administered in China and Uzbekistan.[10]

It is administered in 3 doses over a period of 2 months.[8]

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.[11][12]

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.[13]

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.[8] Subunit vaccines are delivered alongside adjuvants and booster doses may be required.[14]

The company's vaccine manufacturing facility was put into use in September.[15] In February 2021, management said the company had an annual production capacity of 1 billion doses.[8]

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.[9]

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.[16]

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.[17] In August, an additional Phase II trial was launched with 50 participants aged 60 and above.[18][1]

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.[19]

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