September 24, 2021

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Johnson & Johnson COVID-19 vaccine: GBS risks and booster shots

Johnson & Johnson COVID-19 vaccine: GBS risks and booster shots

Johnson & Johnson COVID-19 vaccine: GBS risks and booster shots for immune-deficient people

 

 

 

Johnson & Johnson COVID-19 vaccine: GBS risks and booster shots .  The ACIP meeting of the CDC on July 22 has two main themes: Johnson & Johnson’s GBS and whether people with immunodeficiency need booster injections, pay attention to people with immunodeficiency, not the general population. Provides a lot of useful information.

 

 

 


1. Johnson & Johnson’s GBS problem


Guillain-Barré Syndrome: A rare neurological disease. The pathogenic principle is that the immune system attacks the nerves, causing muscle weakness. In severe cases, it may lead to paralysis. In principle, it is an autoimmune disease. The specific cause of the disease is not clear. 3000-6000 cases occur in the United States each year, mainly caused by respiratory or intestinal infections. Most people can recover, but a small number of people will be left with lifelong nerve damage. The risk is higher in men over 50 and in men.


As of June 30, 100 cases of GBS after Johnson & Johnson vaccination have been reported in the VAERS system, 95 of which are serious in nature and require hospitalization, and 1 case died. It should be noted that this is a rough statistic that occurred after vaccination, and verification of all cases has not been completed.


The average age was 57 years old, and 61 of the 100 cases were men. 84 cases occurred within 21 days after vaccination and 98 cases occurred within 42 days after vaccination. Ten of the 95 severe hospitalized cases required intubation, and one death was a 57-year-old male who had a history of various underlying diseases including heart failure and stroke.


A total of 12 million doses of Johnson & Johnson vaccination corresponding to 100 cases of GBS. The background incidence of GBS is roughly in the range of 1-2 cases per 100,000 people according to age groups. According to the data of Johnson & Johnson vaccine, all age groups have exceeded the background value, and 40-64 years old are about 6-7 times the background value.


In contrast, Pfizer and Moderna have 190 and 162 GBS in VEARS, respectively, but the vaccination rate is much higher than that of Johnson & Johnson, and the incidence rate is close to the background value.


In the active tracking system VSD, the incidence of GBS of Johnson & Johnson is also higher than that of mRNA vaccines, but the overall dose of Johnson & Johnson’s vaccination is too small to confirm the risk, and it needs to continue tracking


At the same time, as of June 27, EMA has received 227 GBS cases after AstraZeneca vaccination, corresponding to more than 51 million doses of vaccination.


Now both the FDA and EMA have included GBS in the risks of Johnson & Johnson and AstraZeneca vaccines.

 

 

 


2. Johnson & Johnson vaccine benefits still far outweigh the risks


Johnson & Johnson’s protection against symptomatic COVID-19 is 66% in clinical trials, and protection against hospitalization is 93%. It should be noted that these are the research results made when multiple mutant strains have appeared, and they are still instructive for now.

Johnson & Johnson COVID-19 vaccine:  GBS risks and booster shots

 


At present, more than 12 million doses of Johnson & Johnson vaccine have been vaccinated, and there are two serious adverse reactions. TTS has reported 38 cases and GBS has 98 cases. The highest risk of TTS is 8.8 cases per million in women aged 30-39, and the highest risk is 15.6 cases per million in men aged 50-64 with GBS.


For women aged 30-39, for every 1 million doses of Johnson & Johnson vaccine, there will be 6-7 cases of GBS, 8-10 cases of TTS, but more than 10,000 cases of COVID-19, 900 hospitalizations, 140 ICU cases, and 20 deaths .


For men aged 50-64, for every 1 million doses of Johnson & Johnson vaccine, there are 14-17 cases of GBS, 1-2 cases of TTS, but more than 10,000 cases of COVID-19, 1,800 hospitalizations, 480 ICU cases, and 140 deaths.


For mRNA vaccines, the current serious adverse reaction is myocarditis. According to statistics as of June 30, the highest risk is in men aged 18-29. There are 24.3 cases per million doses of vaccination, but it can reduce 9600 infections and 300 cases. Hospitalized, 60 cases in ICU, 3 cases died.


It should be noted that these benefits are still underestimated, such as not considering reducing the sequelae of COVID-19. So even with GBS and TTS, the benefits of Johnson & Johnson vaccine far outweigh the risks. The same is true for myocarditis with mRNA vaccines.


Therefore, the CDC strongly supports the continued use of Johnson & Johnson vaccine and encourages everyone to receive the COVID-19 vaccine.

 

 

 


3. The problem of booster needles for people with immunodeficiency


2.7% of American adults belong to the immunodeficiency population, including cancer patients, people who have received organ transplants, innate immunodeficiency, HIV patients, and people who use immunosuppressive drugs.


A piece of data that is particularly noteworthy is that people with immunodeficiency have many breakthrough infections. 44% of hospitalized cases of breakthrough infection in the United States are in this population, and 40% in Israel.


A number of studies have also shown that the same two doses of mRNA vaccine are administered, and the vaccine effectiveness of immunodeficiency populations is lower than that of the general population. Some studies have also shown that 33%-50% of patients with severe immunodeficiency who have not produced antibodies before can produce antibodies if they are vaccinated with the third dose of mRNA vaccine.


The above evidence shows that people with immunodeficiency are indeed at greater risk, even if they are vaccinated, and then booster shots may be helpful.


However, there are still many problems that need to be solved in order to implement the enhancement needle.


First of all, which of the immunodeficiency population needs special attention, the organ transplantation should definitely belong to it, but the individual differences in the use of immunosuppressive drugs are very large, at this time, it may be very dependent on the judgment of the direct medical team.


Secondly, the relationship between antibody titers and protection has not been fully established, especially for people with immunodeficiency. For example, in organ transplant experiments, the antibody titers after the third injection are not high. In this case, it is difficult to follow the enhancement needle. Induce an antibody response to confirm whether there is sufficient protection. And once it is promoted, there are still inconsistent results of existing commercial antibody tests, which are not suitable for confirming the immune response.


Finally, the FDA currently approves two doses and one dose. If you want to change it, you need to be approved by changing the EUA or the official BLA, and the latter can add one more injection through the off label mechanism.


The ACIP meeting pointed out that it is necessary to continue to collect information, study the problem of enhanced injection and mixed injection, and identify which immunosuppressed people need the third injection. But to allow the third stitch to wait for the BLA. At the same time, ACIP also reiterated that people with immunodeficiency should continue to do a good job of personal protection, and family members should be vaccinated.


These suggestions are very reasonable, and the final decision-that is to continue to wait, is not a problem, but I personally think that it is too conservative and not the most reasonable way to push the main reason to wait for the BLA when making the decision. The fastest BLA now is Pfizer, which is also based on the Phase III clinical data of the general population, and the last is two injections. The problem of the immunodeficiency population is indeed related to the BLA, and the approval is indeed related. After the BLA, it is a fully marketed drug. The third injection can be counted as the off label. But now people with immunodeficiency are under-protected and need to find appropriate help from science. At this time, saying that we wait for the BLA first is equivalent to kicking the ball and kicking the problem to the FDA.


In fact, it was also mentioned in the conference whether monoclonal antibodies are used for passive immunization to work. Regeneron applied for preventive use in April. This aspect can actually be more radical.

 

 

 


4. In the face of repeated epidemics, the best way is still to increase the vaccination rate


On July 17, Delta accounted for 80% of the new cases in the United States. The daily increase is now back to the level of 60,000, and many of these come from the states with the lowest vaccination rates.


As of July 21, 68.4% of American adults over the age of 18 had at least one shot, and 59.6% had been fully vaccinated. The growth of the inoculation rate is still very slow, which is very regrettable and very dangerous.


The conclusions of some recent studies are a bit big, causing unnecessary anxiety.


One is the protective effect of Johnson & Johnson vaccine on Delta. A research team in New York used serum for 80-90 days after vaccination and found that the neutralizing ability against Delta was 5 times lower than that of the original virus. According to the modeling in the Nature medicine paper , Some people have fallen to the point where they cannot protect against symptomatic infections. The researchers suggested that the Johnson & Johnson vaccine has low effectiveness on Delta, and it needs to be strengthened. This research was reported by the New York Times, which also attracted a lot of attention.


First of all, this is in conflict with the serum neutralization experiment of volunteers in the Johnson & Johnson clinical trial. Why is it different? It needs more careful evaluation and should not rush to a conclusion with an experiment.


Secondly, and more importantly, based on the true effectiveness observed in Phase III clinical trials, Johnson & Johnson is also effective for immune escape, which is generally considered the most serious beta, and it is also a shot.


Now many in vitro serum neutralization experiments take the decrease of neutralizing antibodies over time as the basis for the decrease in effectiveness. This kind of research is very one-sided. It should not be used to replace actual effectiveness observations, nor should such experiments be used to infer the need for enhanced needles. We can go back and look at the level of evidence in evidence-based medicine. The randomized double-blind phase III clinical trial is definitely higher than the in vitro experiment. After all, the serum neutralization experiment is an in vitro experiment, which has its meaning, but it cannot be used. To overturn the results of Phase III clinical trials with higher levels of evidence.


In addition, Israel now says that Pfizer’s effectiveness has dropped to 39%. The specific research methods and detailed data have not yet been announced. This is based on the study from June 20 to July 17, which is about one month later than the previous 64%. Even if the antibody declines, generally except for the sharp decline in the first two months, the decline will be moderated later. Therefore, the effectiveness of Israel is reduced by 30% every other month. I find it difficult to understand. Especially in Europe and the United States, Delta-induced infections are still concentrated in people who have not been vaccinated. Therefore, it is better to wait and see the conclusion of Israel.


These hasty conclusions can easily cause anxiety, which is a pity, but it is indeed a special period, and this situation is hard to avoid. In the past, many scientific researches were discussed and analyzed in small circles in the scientific research community. Many times there was more time to discuss scientifically. If the conclusions are larger, there will be a chance for peer debate and correction. It won’t cause the whole society to pay attention to it all at once. Now there are advantages and disadvantages. The advantage is that it can provide more timely information. The disadvantages are just mentioned. Sometimes, some hasty and questionable titles are disseminated as scientific conclusions, causing unnecessary misunderstanding and anxiety.


In the whole process, it is a bit regrettable that there are too few original researches on the true effectiveness and safety of vaccines in the United States. For the effectiveness of Delta, we quoted from the United Kingdom, for beta, we quoted from Qatar, and the United States did it here, mostly in serum neutralization experiments. This situation is caused by problems in the U.S. medical system. Others have very good and detailed electronic medical files for timely analysis. The United States is problematic in this regard. After more than 300 million doses of mRNA vaccines, the CDC’s vaccine effectiveness was tested by more than 4,000 people. The breakthrough infection data has not been sequenced on the genome. These are ridiculously backward. Johnson & Johnson has now received 12 million doses in the United States and switched to Israel or the United Kingdom. Let alone 12 million doses, there are effective tracking data for 1 million doses. Even if the Chilean real-world study published on NEJM a week or two ago confirmed the effectiveness of Coxing, it was recorded by more than 12 million people.


In addition to security issues, the VAERS and VSD in the United States cannot be considered ineffective. But an obvious problem now is that other countries and regions need to find problems first, so that the two systems can see if the United States has the same problems based on these problems. The thrombus was first found in AstraZeneca in Europe, and myocarditis was first found in Israel. I thought that GBS was finally found by VAERS, but now from time it may also be found after AstraZeneca in Europe came out. CDC is very transparent in security, but still lags behind in research.


Due to such shortcomings in the US medical system, even though the US has used a lot of vaccines, most of our scientific evidence still relies on data from Britain, Israel and other countries. But even so, this does not affect the adequacy of evidence for the vaccine. In the face of repeated epidemics, the best measure is still to be vaccinated in time.

 

(source:internet, reference only)


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