(Bloomberg Opinion) – Sam Fazeli, a Bloomberg Opinion reporter dealing with the pharmaceutical industry for Bloomberg Intelligence, answered questions about vaccine safety after a broth of possible allergic reactions to Covid-19 Moderna Inc vaccine . in San Diego to recommend a medical expert to hold back some photos. from the same batch. This follows reports from Norway earlier this month that there was a higher mortality among seniors who received the Covid-19 image developed by Pfzer Inc. and BioNTech SE. The conversation has been edited and collated.
Moderna vaccine news out of California and the results of Pfizer-BioNTech mortality in Norway raised warnings, at least initially, and Moderna shares received a major blow. How worrying are these things?
It is absolutely vital that any side effects and issues related to any vaccine or drug are followed closely. This is especially true in the case of Covid-19 vaccines, considering that the scale and speed of inoculations is far higher than anything in modern medical history. It is also natural that there should be a warning as the vaccines are being distributed. But it is equally important that any issues are dealt with sensitively and sensibly, given the extent to which riding is on the success of the vaccination program. With regard to deaths in Norway, the authorities should have first looked out that the high number of deaths per vaccine subject – about 1 person per 1,000 – was a coincidence. or linked to the use of the vaccine in people with other side effects. health conditions that would not normally be candidates for any vaccine.
A quick comparison with the US suggests something else is going on. Out of 14 million vaccines, the U.S. Centers for Disease Control and Prevention says it has received reports of 44 possible vaccine-related deaths as of Jan. 15, and none have been linked. directly to the picture but occurred shortly after dose. This shows that Norwegian statistics are tired. The situation with the allergic reactions in California is different. We know that these vaccines can cause an allergic reaction. The CDC vaccine safety database contains 63 reports of allergic reactions to Covid-19 vaccines, five of them after a Moderna shot. While that data does not appear to include the most recent events in San Diego yet, it is entirely possible that the collection of opinions was there at the same time. But it is important that the public know that a system is in place that reviews and evaluates these issues, which they must trust. For San Diego, Moderna is working with the CDC, the Food and Drug Administration and California officials to monitor and better understand the situation. While it’s hard to hold back the rest of the Moderna batch, there don’t seem to be any other reactions, and there is nothing to say that the vaccine in general is a threat.
The Moderna and Pfizer vaccines use similar technology. What is their safety data?
As mentioned above, the CDC database, which is updated every Friday, contains all the side effects reported to the group. Anyone can access and analyze the data. Interestingly, cases of Bell’s palsy occur in connection with the Pfizer-BioNTech test, and thrombocytopenia – extremely low platelet levels – which can occur after a strong immune response. To date, 41 cases of “facial paralysis” and three cases of thrombocytopenia have been reported. Again, in the context of 14 million vaccines, these numbers are, so far, very low. Other side effects of both vaccines are those that are usually expected after vaccination: fever, pain and cold.
Are there any risks associated with these new vaccines that may emerge over time?
Any new vaccine may have long – term risks, but most vaccine – related side effects tend to occur within the first two months of vaccination. In general, the risks of vaccines are very low compared to the benefits they provide. Consider polio vaccines for example, which can lead to rare cases of “paralytic poliomyelitis” (or polio-like paralysis caused by the vaccine itself) at rates of around one in every 3 million doses. Compare this to the 1952 polio outbreak in the USA, which resulted in nearly 58,000 infections and 3,000 deaths. And remember, because of large vaccines, polio has not been seen in the U.S. since the 1970s. That said, it is important to note that when dealing with vaccines at such a large scale, there may be events of illness or death that may be related to the vaccine. For example, in 2018, 655,381 people died from heart attacks in the U.S., according to the CDC, or nearly 1,800 per day. Some people are more likely to have a heart attack on or shortly after their vaccination doses with a strong convulsion. The National Cancer Institute estimates that approximately 1.8 million cancer diagnoses will be made in the U.S. in 2020. Assuming the same number in 2021, many people will be diagnosed with cancer shortly after their diagnosis. receive their doses of the Covid-19 vaccine. The key is to look for excessive levels of disease, and this will take time. Going out with confirmations that a dose of Covid-19 vaccine caused this or that case is very wrong.
What about other types of Covid vaccines?
The only other Covid-19 vaccine used in mass vaccination is the one from AstraZeneca-Oxford University, almost entirely in the UK No cases have been reported with that vaccine to date. Its side effects are similar to those of Pfizer-BioNTech and Moderna. There was no indication of an allergic reaction to the Astra vaccine.
How is safety tested first? How confident can we be in the set of bar rulers?
The first step is to get large numbers of people admitted to late stage III tests. Pfizer and BioNTech and Moderna had 44,000 in their US tests. AstraZeneca and Johnson & Johnson are at the same levels as their tests. With half of those people getting the vaccine, more than 70,000 people will have been vaccinated, especially as some former placebo are now vaccinated. These people are largely under a safety microscope, and over time more and more data will be collected. The enhanced vaccine safety database is then maintained by the CDC, which is available to anyone.
What is a real vaccine problem like?
Neurological side effects, such as seizures or Guillain-Barre syndrome, have been observed with vaccines. Healthcare professionals are keen to look out for these if they happen, and developers would look to change something in the process or limit the vaccination to a specific group of people while trying to take risks. reduce. The worst type of side effect is one that you can’t keep a close eye on or explain. So far we have not seen anything like it.
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