The government plans to roll out "antibody cocktail therapy" that can be used for mildly ill patients with the new coronavirus nationwide, and administration in accommodation facilities has begun in Tokyo and Fukuoka prefectures.
Some say that administration at home should be allowed, but the country continues to be cautious as symptoms such as anaphylaxis have been reported overseas.
Antibody cocktail therapy was approved in Japan in July for patients with mild to moderate disease of the new coronavirus.
The government plans to actively utilize it, such as by promoting distribution to medical institutions, mainly in areas subject to the state of emergency.
Initially, it was intended for people who were hospitalized, but due to the number of people who could not be hospitalized, from mid-August, administration at accommodation facilities and temporary medical facilities was also permitted conditionally. rice field.
On the other hand, according to the American pharmaceutical company that developed it, symptoms with suspected side effects such as fever, headache, anaphylaxis, dyspnea, and decreased oxygen saturation have been reported in those who received the drug.
Due to the limited clinical data, the possibility of other symptoms cannot be ruled out.
Some home doctors have said that administration at home should be allowed, but the Ministry of Health, Labor and Welfare continues to be cautious, saying that doctors need to monitor the progress.
Experts “Carefully assess and create a system that can be widely used”
Professor Kazuhiro Tateda of Toho University, who is a member of the government subcommittee on measures against the new coronavirus and is also involved in supervising the booklet created by Chugai to introduce the effects of drugs and the risk of side effects, said, "In Japan. The availability of antibody cocktail therapy is an important step. How to use it effectively becomes very important. "
On the other hand, "It is necessary to carefully determine whether or not there are side effects peculiar to Japanese people. First, carefully check on a scale of hundreds or thousands of cases, and then change to a system that can be widely used. Isn't it required? "
There are also reports of dyspnea overseas
According to the American pharmaceutical company Regeneron, which developed antibody cocktail therapy, clinical trials conducted overseas have confirmed that the risk of hospitalization and death is reduced by approximately 70%.
On the other hand, of the 4206 patients who received the drug in the clinical trial, 10 patients, or 0.2%, had symptoms such as fever, dyspnea, decreased oxygen saturation, chills, arrhythmia, chest pain, weakness, headache, and hives. ..
A severe allergic reaction called anaphylaxis has also been reported in those who received it.
At least one of these was the need to administer a drug to relieve the symptoms.
It's unclear whether these symptoms are side effects or those caused by the new coronavirus, and both have recovered, but pharmaceutical companies require that they be observed for at least an hour after administration.
In addition, since these symptoms have been reported within 24 hours after receiving the drug, the Ministry of Health, Labor and Welfare is requesting that a system be in place for sufficient health observation during that period.
On the other hand, regarding the effect on mutant viruses, the medical treatment guide prepared by the Ministry of Health, Labor and Welfare considers that the effectiveness may not be expected, and we will consider whether it is appropriate to administer it based on the latest information.
The national usage policy is
In antibody cocktail therapy, the action of the new coronavirus is suppressed by administering a mixture of two types of antibodies.
Last November, it received an emergency use permit from the US FDA = Food and Drug Administration, and was also used to treat former US President Trump.
In Japan, Chugai, which has signed a license agreement with a related company, applied for approval, and the Ministry of Health, Labor and Welfare approved it on July 19.
The target is mild to moderately ill patients, elderly people aged 65 and over, and those at risk of aggravation such as underlying illness, and it is the first therapeutic drug that can be used for mildly ill patients in Japan.
On the other hand, in overseas clinical trials, it was reported that some people had dyspnea within 24 hours after administration, and the Ministry of Health, Labor and Welfare initially approved the use only for inpatients because it requires observation by a doctor.
However, due to the rapid spread of infection, the number of patients who cannot be hospitalized has increased. It was approved to be administered at the "hospitalization waiting station".
According to the Ministry of Health, Labor and Welfare, administration has already begun at some lodging facilities in Tokyo and Fukuoka prefectures.
In addition, Osaka Prefecture has set up a medical institution that allows short-term hospitalization, administers it to patients, confirms that their condition is stable, and then begins an initiative to transport it to accommodation facilities on the 20th.
The supply method is also changing.
Initially, the country purchased everything in the country, saying that supply was limited due to rising global demand, and then supplied only the patients applied for by medical institutions.
However, since there is no data to support the efficacy when administration is started on or after the 8th day after the onset, prompt administration is required, so it is currently prioritized mainly in areas where priority measures such as state of emergency and prevention of spread have been issued. We also provide.
The government has explained that it has secured a sufficient amount, but has not disclosed the specific amount or the contents of the contract.