On August 23, Pfizer / biontech’s new crown vaccine was officially approved by FDA (people over 16 years old). This is a little earlier than the approval expected in September, which proves that the FDA is indeed full mobilization and full speed promotion this time.
Some people may wonder what vaccines have not been on the market for a long time and are still being approved. Previously, Pfizer / biontech vaccine was listed according to the approval of emergency use authorization at the end of 2020. Emergency use authorization is a special drug audit channel under the public health crisis. The specific standards will be formulated by FDA according to the situation of the crisis. For example, for the new crown vaccine, a very important standard is that at least half of the people in the phase III clinical trial will be tracked for 2 months after the completion of vaccination. This is why we say that the emergency use of the authorized new crown vaccine has two months of phase III clinical trial safety data.
The 2-month follow-up of emergency use authorization is not arbitrary, but because according to previous safety studies of all vaccines, it is found that adverse reactions basically occur within 2 months after vaccination. This is why we say that although it is a new vaccine and is used urgently, the safety of the vaccine is fully guaranteed.
The approval on August 23 was the formal approval of Pfizer vaccine as a conventional drug. Because the vaccine is a biological product, that is, a macromolecular drug manufactured through complex biological reactions, which is very different from small molecular chemicals such as aspirin, the marketing application of the vaccine is called bla (biological lisence application). The Pfizer / biontech vaccine application was approved, that is, their BLA application was approved by FDA.
BLA is no longer the scope of emergency use authorization, but the audit channel of conventional drugs. Its standard is for all biological agents to be listed, including all vaccines. The adoption of BLA for Pfizer’s /BioNTech vaccine means that its effectiveness, safety and production test data have reached the standard of the vaccine’s normal listing, and it has the same status as the MMR vaccine, poliovirus vaccine, hepatitis B vaccine, HPV vaccine and so on.
The data volume of BLA is different from that of previous emergency authorization. When Pfizer / biontech applied for emergency use authorization, all documents added up to more than 110000 pages, and now the BLA application has reached 340000 pages. We are most concerned about the effectiveness and safety data. The biggest difference in this regard is that the BLA application uses the 6-month tracking data of the phase III clinical trial. In other words, it is 4 months longer than the time tracked in the previous emergency use authorization. It should be noted that in terms of safety, no new problems have been found in the six-month tracking time. It can be seen that the safety of the vaccine is guaranteed – even according to the safety standards of the traditional vaccine on the market, it is still no problem.
What changes will it bring after the official listing? Pfizer / biontech has vaccinated more than 100 million people in the United States, and it is also one of the most widely used vaccines in the world. It doesn’t make much sense for many people to come to the title of “emergency use authorization”. However, the approval of BLA will still have some practical implications.
First, what is most expected but may not appear in the end is that some people who hesitate to accept a officially approved vaccine will choose to accept it. Indeed, some people would say “this is an emergency authorization, this is experimental” when explaining why they are unwilling to receive the new crown vaccine. Theoretically, if this is the reason, the current BLA approval will solve this problem. However, I personally doubt the proportion of such people or whether they can be persuaded. To put it bluntly, for some people, “there always will be something”.
Second, the formal approval will help implement the compulsory vaccination policy for enterprises, schools and other institutions. With the rampant Delta, more and more American enterprises began to force employees to vaccinate with the new crown vaccine. Although the Ministry of justice and many legal scholars have pointed out that it is no problem to require compulsory vaccination even for the emergency use of authorized vaccines, after all, this is a controversial topic. The official approval means that the new crown vaccine is no longer different from other vaccines. Since schools can require students to be vaccinated with MMR and hospitals can require employees to be vaccinated with influenza vaccine, it will not be a problem to force students to be vaccinated with new crown vaccine now. Therefore, it can be expected that more compulsory vaccination requirements will appear in the United States recently. The U.S. Department of defense also said after the news approved by the FDA that it would formulate a policy of compulsory military vaccination.
Third, Pfizer / biontech will be able to market the vaccine. According to the law, emergency use of authorized drugs cannot be marketed. Therefore, although advertisements for various drugs often appear on TV, it is impossible to have a special advertisement for a new crown vaccine – the health department can make a general recommendation to encourage the vaccination of the new crown vaccine. However, unlike commercial advertisements, it can not involve specific products or even say that vaccination can prevent the new crown (because once it is said, it has the nature of medical advertisement). With the approval of BLA, Pfizer / biontech can commercially promote its new crown vaccine like any listed drug.
Pfizer / biontech vaccine also has a trade name – comirnaty, which will be seen more in marketing. In fact, I’m curious. Most drug advertisements are extremely boring – you can see from all kinds of difficult and inexplicable drug trade names. One or two, the gap between them and the high-grade marketing of Budweiser beer in the super bowl can be measured by light years. The new crown vaccine is a product attracting much attention. I don’t know if it can be a little advanced in the ability of advertising business. Of course, whether more marketing can drive more people to vaccinate is a more important issue.
Fourth, from the perspective of vaccine use, drugs under emergency use authorization cannot be used beyond the label. The Pfizer / biotech vaccine approved in the emergency use authorization is two injections, so anyone can only get two injections. The doctor can’t say that according to my medical judgment, you can’t get two injections, so you need to add one. The previous additional needles for immunosuppressed people were implemented only after the FDA revised the emergency use authorization.
With the approval of BLA, Pfizer / biontech vaccine is a common drug. Doctors can make off label recommendations based on their own medical judgment. In other words, although there are two injections on the drug label, the doctor can recommend the patient to have a third injection. Since the United States has just announced its intention to start implementing enhanced needles for the general population on September 20, the third needle has become a matter of concern for the general public. It is worth paying attention to whether someone will try to obtain the third needle by off label drugs.
It should be noted that the BLA approved the use of Pfizer / biontech vaccine for people over the age of 16, and the emergency use authorization is still in the state of 12-15 years old, so the vaccine has become a common drug for people over the age of 16. Formal listing applications aged 12-15 need to be done separately. According to the main time limiting factor – 6-month safety data, it still needs to wait for some time. Clinical trials for children under 12 are also ongoing and will not be affected by today’s BLA approval. Moderna’s BLA application has been submitted and is expected to be approved in a few weeks. Johnson & Johnson’s emergency use authorization is about 3 months later than the two mRNA vaccines. The data tracked for half a year has not been released. It is estimated that once enough data are collected and no accidents occur, it will also apply for the same.
At the end of 2019, people first met COVID-19. In March 2020, the first new crown vaccine came into clinical trials. By the end of 2020, several new crown vaccines showed good efficacy. Until now, the first new crown vaccine was fully approved. In this limited time, billions of vaccines were produced worldwide. Although the epidemic is still very serious, the rapid development of science and technology has prepared the best weapon for us to fight against the new crown, whether we can use these equipment well in the end depends on people’s own behavior.