Can the HPV vaccine be used to prevent cervical cancer with a single shot? Hundreds of billions of vaccine leaders flash crash, experts: the effect is not easy to say

Source of this article: Times Finance Author: Li Aohua

On January 27, 2022, medical staff at the Puxi Community Health Service Center in Haizhou District, Lianyungang, Jiangsu Province, vaccinated female college students with the nine-valent HPV vaccine. Image source: Visual China

As a result of an official document from the World Health Organization (WHO), on April 14, Zhifei Bio (300122. SZ), Wantai Bio (603392. SH) share price both flash crashed.

According to the official website, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) met from 4 to 7 April to consider the efficacy of the hpvide vaccine single-dose vaccination regimen. SAGE's review concluded that the protection of a single dose of HPV vaccine provides solid protection, comparable to that of 2 or 3 doses.

According to SAGE's recommendations, women aged 9 to 20 years can receive 1 or 2 doses of the regimen; women over 21 years of age should receive 2 doses at 6 months apart; and immunocompromised people, including people living with HIV, should receive 3 doses, at least 2 doses.

At present, there are 5 HPV vaccines approved by the State Food and Drug Administration, namely the divalent HPV vaccine of GlaxoSmithKline (GSK), the merck quadrivalent and nine-valent HPV vaccines represented by Zhifei Biologics, and the Wantai Biologics, Watson Biologics (300142. SZ) two self-developed bivalent HPV vaccines. The above-mentioned HPV vaccines that have been approved for marketing require 2 or 3 injections.

After the news flowed out, the stock prices of Zhifei Biology and Wantai Biology crashed. Zhifei Biology once fell by more than 18% intraday, and finally closed at 116 yuan / share, down 14.19%, and the total market value evaporated by more than 30 billion yuan. Wantai Biology also fell to a halt in the intraday, and finally closed at 257.59 yuan / share, down 9.46%, with a total market value of 156.4 billion yuan.

Zhifei Biological related people replied to Times Finance that the company has noticed the above news, but how much the news will affect the company needs further study.

Wantai Bio issued an announcement in response that the company's products are vaccine products approved and registered by the State Food and Drug Administration under a large number of clinical studies and data demonstrations. At present, the company's approved 2-valent HPV vaccine in China is 3 doses (women aged 9-14 years can receive 2 doses). Under the current national drug regulatory policy, if the secondary change of vaccination is carried out, a series of clinical, data support and registration change procedures need to be performed, which will take a certain amount of time, and there will be no significant impact on the company's operating performance in the short term.

According to WHO, cervical cancer is the fourth most common type of cancer in women worldwide, with more than 95% of cervical cancers caused by sexually transmitted HPV, 90% of which live in low- and middle-income countries.

Globally, hpV vaccination has been slow. As of 2020, the global coverage rate of 2 doses of HPV vaccine is only 13%, well below the 90% target.

WHO Director-General Nothemba (Nono) Simelela commented: "I firmly believe that it is possible to eliminate cervical cancer. In 2020 we launched an initiative to eliminate cervical cancer, and the single-dose recommendation has the potential to help us achieve our goal of getting 90% of girls vaccinated against HPV by age 15 by 2030. ”

Nothemba (Nono) Simelela said single-dose vaccines are less expensive, take up fewer resources and are easier to manage. The single-dose regimen is more conducive to re-vaccination for different age groups, eliminates the follow-up management problems associated with multiple vaccinations, and can save financial and human resources and invest in other health projects.

Vaccine expert Tao Lina told Times Finance: "Some studies do show that the protection effect of a single dose of HPV vaccine is good. ”

However, he also stressed that from the perspective of the general principle of vaccine action, 1 dose of vaccination has not been strengthened, and whether this immune effect can be sustained is not yet conclusive.

"In principle, for non-live vaccines, 2 doses are appropriate, and very few vaccines only need 1 dose. Live vaccines are better because they mimic natural infections, so there are also cases of 1 dose of vaccination, such as live hepatitis A vaccine, BCG vaccine (although the effect is not good), rubella vaccine and so on. However, live vaccines require 2 doses, such as measles vaccine and mumps vaccine, chickenpox vaccine, Japanese encephalitis live vaccine, rotavigic vaccine generally need 3 doses. Taurina said.

Although the stock prices of Zhifei Bio and Wantai Bio have plummeted, some institutions still expressed their continued optimism and believe that the news will not have much impact on the company's performance in the short term.

Huaxi Securities pointed out that the current HPV vaccine clinical trials developed by HPV vaccine companies are all full immunization procedures, and a single dose lacks clinical data support. The WHO's conclusion that this is not relevant may be based on considerations for the global shortage of HPV vaccines, but there is no doubt that vaccination must be fully immunized to be most effective. And in the terminal vaccination, you must first pay the full amount of the whole immunization dose before you can queue up to make an appointment for HPV vaccine.

Debon Securities believes that the fundamental reason why the WHO considers the clinical effect of a single dose of HPV vaccine is that HPV vaccines are still in a state of short production capacity in the world, and after understanding this background, the trend of domestic HPV vaccine exports can be verified again.

According to the estimation of the number of batches issued by the Central Inspection Institute, Southwest Securities approved 12 batches of Merck 4-valent HPV vaccines represented by Zhifei Bio in the first quarter of 2022, with an estimated batch issuance volume of 2.3 million to 2.5 million; 9-valent HPV vaccines were approved and issued 10 batches, with an estimated batch issuance volume of 4.2 million to 4.5 million units, and the overall sales volume of hpvavier vaccines of the company is expected to increase by 70% to 90% year-on-year.

"I don't think it's likely to implement a 1-dose regimen in 3 to 5 years. For many people who have only received 1 dose of the vaccine for various reasons, this news can be a comforting effect. Taurina told Times Finance.