Recently, Pfizer's vaccine team in China reported layoffs. Its 13 valent pneumococcal polysaccharide conjugate vaccine (PCV13 vaccine, trade name: Pei'er 13, Prevenar 13), which is currently being sold domestically, will be represented by Science Park Trading, a subsidiary of Shanghai Pharmaceuticals.
Currently, Pei'er 13 is the only vaccine product sold by Pfizer in China. Previously, the Prevenar family ranked first in global vaccine product revenue and was once the only vaccine product among the top ten drugs in global revenue, until it was surpassed by Merck's HPV vaccine Gardasil/Gardasil 9 in 2020.
However, the performance of this star product in China is not very good. In other words, the handover of Pei'er 13 to the Science Park Trading Agency this time is not only due to the background of Pfizer's cost reduction and efficiency increase, as well as the opening of layoffs in multiple regions, but also due to the commercial environment of domestic vaccines and the unique characteristics of this vaccine itself.
Our country implements a "batch issuance" system for vaccines, which means that the Chinese People's Procuratorate needs to conduct mandatory inspections on each batch of vaccine products that leave the factory or are imported before they can be put on the market or imported for sale. Starting from April 2021, the Chinese People's Procuratorate will no longer disclose the batch issuance quantity of each batch of vaccine products, only the approved batches. Therefore, the sales situation can be inferred based on the batch issuance quantity announced by the enterprise itself and the approved batches of all products.
Pei'er 13 was approved in China in November 2016 and has since monopolized the domestic market for about 3 years. From 2017 to 2019, 8 batches, 18 batches, 22 batches, and 27 batches of products were approved respectively. Until January 2020, Watson Biotech's similar product Woanxin was approved, becoming the first domestically produced and second globally produced PCV13 vaccine. Subsequently, in September 2021, Kangtai Biotech's Weimin Feibao was also approved for listing and participated in the food distribution market.
In its first year of listing, Woanxin's squeeze on the market share of Pei'er 13 is evident. In 2020, Pei'er 13 and Woanxin were approved for 6.4235 million and 4.4651 million doses respectively. Although the number of 13 batches issued by Pei'er has increased by more than 30% year-on-year, its proportion has plummeted from 100% a year ago to less than 60%.
Q4 2023 is the data as of the time of publication, not the complete data for that quarter. Data source: Dingxiangyuan Insight database, mapping: Chen Yang, Pei'er 13, and Woanxin have almost competed for a period of time, and their own batches are also increasing. In 2021, they reached 59 batches, almost doubling from the previous year. However, it does not stem from natural market growth. A domestic vaccine industry practitioner speculated to Interface News that this may be due to the fact that Pei'er 13 faced re registration in the past, and Pfizer's re registration submission was relatively late. They may be concerned that the re registration may not be smooth and affect market supply, so there were many batches that year.
This also explains the reason for the cliff like decline in the number of batches of Pei'er 13 in 2022. Throughout 2022, Pei'er 13 only received one batch of products in the first quarter, and it was not until 2023 that a new batch was approved, but the quantity was also lower than the two domestic products.
In other words, the gap in 2022 means that Pfizer needs to digest the previously surge in approved inventory. But this is not easy, and the most obvious thing is that its opponent also has Kangtai's Weimin Feibao. At the end of 2021, Zhang Lingyan joined Pfizer as the General Manager of the Vaccine Business Unit. Prior to this, she served as the National Senior Director of the Vaccine Business Unit at MSD. At the same time, Pfizer's domestic vaccine business reported pilot "outsourcing" news, entrusting vaccine sales and promotion in peripheral cities to third-party pharmaceutical sales outsourcing companies, indicating the pressure on Pfizer's vaccines. However, the news was not confirmed by Pfizer at the time.
In the future, personnel changes in the Pfizer vaccine team will also occur frequently. Starting from June this year, Yang Bei took over from Zhang Lingyan, a veteran who grew up within Pfizer. In September, the Vaccine Business Unit adjusted its structure again, with North China, South China, and market platforms under its leadership, led by Hao Yikai, Shi Yinli, and Jin Xinqing.
In fact, the reason why Pei'er 13 is not easy to sell is not only because it has lost its exclusive advantage, but also because it has shortcomings in terms of age of application.
Prevenar13 was approved in the United States in February 2010, for the first time for infants and children aged 6 weeks to 5 years (before their 6th birthday, the same below). However, when Prevenar13 was approved in China, it was suitable for infants and young children aged 6 weeks to 15 months, and it was not until April this year that it was extended to 5 years old.
Before the approval of Pei'er 13, the domestically imported vaccine was Pei'er 7, which is a 7-valent pneumococcal polysaccharide conjugate vaccine. By 2015, the import license for Pei'er 7 had expired, and Pfizer faced the dilemma of having no products to sell. According to industry media reports from the Health Bureau, there is a saying in the industry that in order to catch up with the listing progress, Pfizer did not meet the indications for under 5 years old like the 7-valent vaccine, but adopted a rapid listing strategy, only reaching the age of 15 months.
The aforementioned vaccine industry practitioners further explained to Interface News that the more age groups of indications, i.e. the larger the sample size, the higher the cost, the longer the enrollment time, and the higher the risk of clinical trial failure. To cover up to 5 years old, it generally requires multiple age groups including 6 weeks to 6 months old, 7 months to 11 months old, 12 months to 23 months old, and 24 months to 5 years old. If the experiment is successful, all age groups need to be successful.
From the perspective of vaccination procedures, the standard vaccination procedure for Pei'er 13 is 1 dose of basic immunization at 2, 4, and 6 months old, with the first dose available at 6 weeks old and 1 dose of booster immunization at 12-15 months old. Among them, most provinces require basic immunization to be completed within 7 months of age (<210 days), while basic immunization in Beijing, Guangdong and other places can be relaxed to be completed within 11 months of age, and vaccination beyond the age limit is not possible.
In contrast, both Woanxin and Weiminfeibao are suitable for the age range of 6 weeks to 5 years old when they were launched, which means that domestic products are more suitable for a wider age range and can be vaccinated after 7 months of age.
PCV13 vaccination program. From clinical experience, there are many vaccines that infants and young children need and can receive from birth. A parent told Interface News that before the domestic vaccine was approved, they wanted to take their child to get vaccinated with Pei'er 13, but the child was over 6 months old and therefore unable to get vaccinated. The reason is that there are too many vaccines (that need to be vaccinated) that cannot be arranged. If a child has a fever or illness, it will be delayed again and again.
In fact, invasive pneumococcal infection poses the greatest risk to children under 1 year old, and following the process of vaccination at 2 months of age provides the best protection for children. Vaccine expert Tao Lina also told Interface News that although there are many vaccines that children need and can receive, multiple vaccines can be administered simultaneously in different parts of the body.
"It's just that you feel it's not possible to get vaccinated at the same time, but your body doesn't feel anything is wrong," Tao Lina said. There are indeed parents in clinical practice who are worried that their children won't be able to receive multiple vaccines, which requires vaccination doctors to provide scientific advice from a preventive and protective perspective. On the one hand, the PCV13 vaccine belongs to self funded vaccines, which do not have assessment indicators for doctors and lack motivation themselves; On the other hand, there is also a tendency for vaccination doctors to avoid responsibility and fear taking responsibility for adverse reactions. Therefore, in clinical practice, it may affect the vaccination of infants and young children before the age of 6 months. This may also be the reason why Pei'er 13 is difficult to sell.