According to foreign media reports, on January 21, local time, the French Health Administration (HAS) approved the use of Pfizer's new crown oral drug Paxlovid( Paxlovid), which is recommended to be used as an early treatment drug for new crown patients who do not need oxygen and are at risk of severe illness. Up to now, the United Kingdom, the United States, Canada, Australia and other countries have approved the use of the new crown oral drug.
It is reported that the oral drug paxlovid (Paxlovid) produced by Pfizer has a significant effect in preventing hospitalization and reducing mortality of high-risk patients, and can be used to treat mild to moderate new crown pneumonia. Pfizer's clinical trial results showed that patients who took medication within three days of developing symptoms had an 89 percent lower risk of hospitalization or death. It is reported that the drug can effectively interfere with the replication ability of the virus, and patients only need to take the drug at home and take a course of treatment (generally 5 days).
Infographic. Pfizer's new coronavirus oral drug Paxlovid.
However, paxlovir, while less side-effect, interacts with a range of medications that treat blood pressure, cholesterol and many widely used medications, meaning that patients who want to take paxclovir must pause taking other medications.
In addition, many countries have approved another COVID-19 oral drug developed by Merck, Molnupiravir. It is reported that the drug can reduce the hospitalization or mortality of high-risk patients by about 30%, but the side effects are larger. The study said that compared to Paxlovre, the drug was less safe.
Distributed by population, 160,000 courses of drugs "cup of water"
For Paxlove, Dr. Eric Topol, executive vice president of the Scripps Research Center in San Diego, said this is the most significant breakthrough in the fight against the virus since the outbreak of the global COVID-19 outbreak. "It's very rare that this drug has reduced the number of hospitalizations and deaths due to COVID-19 by almost 90 percent, and there have been no safety issues," he said. ”
At the same time, he also said that the supply of this drug is now very limited, and only 160,000 courses of paxclovir are provided in the United States, which is a drop in the bucket compared with the tens of millions of confirmed cases in the United States.
The U.S. Department of Health and Human Services said it would distribute Paxlove and Monumpiravir according to the population of each state. But for severely affected states, the doses allocated are far from sufficient. New York State Department of Health Director Bassett said the 20,000 doses of paxclovir distributed to New York State were far from adequate to cope with the surge in COVID-19 cases.
Desi Curtis, chief pharmacy executive of the UCSF Health Service, said UCSF Is the only one of UC's five campuses, including Los Angeles and San Diego, to receive the paxclovir drug. "But we only got 40 courses of medication and ran out in less than 10 days," she says. The next batch of drugs will not arrive until the end of January. ”
She added that once Paxlope ran out, they had to switch to monopilabvir. In the past two weeks, the U.S. Department of Health and Human Services has distributed a total of about 400,000 courses of monubiravir to states, while Paxlopvir has been allocated only a quarter of it.
Infographic. New Yorkers in the United States pass by the NEW CROWN test car.
Sterling Ranson, president of the American Association of Family Physicians, who lives in coastal Virginia, said the nearest retail pharmacy to his home can sell oral COVID-19 drugs. The nearest temporary store is an hour's drive from his home. "This is a barrier for COVID-19 patients who are older, can't drive or can't afford to travel," he said. ”
Joseph Barrokas, an infectious disease specialist at the University of Colorado School of Medicine, also expressed concern, saying, "This approach is unfair to vulnerable people." Hopefully, the federal government will find a way to ensure that vulnerable people also have access to this oral drug to treat COVID-19. ”
The purchase process is complicated, and doctors are worried about increasing the risk of infection
In addition to the small supply, the average patient needs to go through a complicated procedure to obtain these two ORAL drugs. Foreign media said that if patients want to buy these two new crown oral drugs, they need to go to the hospital or test site for multiple examinations within five days and obtain a prescription.
The emergency use authorization letters for both drugs state that the right to prescribe is limited to doctors and staff with relevant qualifications. This means that infected patients need to go to the testing point first, go to the hospital to get a prescription from the doctor, and finally go to the pharmacy to buy drugs. Anna Zeko, Alaska's chief medical officer, said: "Even if everything goes well, patients need to be in and out of at least three places to get their medicines. ”
She expressed concern, saying the requirements would make infected patients enter and leave public places more often and could increase the risk of infection for others. In addition to this, there are also experts who say that the tedious process of obtaining drugs can cause patients to miss the optimal period of treatment. It is reported that the earlier the new crown oral drug is used, the more effective it is, and the effect is not good later.
The U.S. Drug Organization says the way to alleviate the problem is to give pharmacists the right to prescribe oral COVID-19 drugs. However, according to the U.S. Food and Drug Administration (FDA), only doctors, physician assistants, and nurses with advanced practicing licenses have the right to prescribe ORAL DRUGS for COVID-19.
However, pharmacists say the decision ignores the work they have done for COVID-19 patients. Kurt Proctor, senior vice president of strategic initiatives at the National Association of Pharmacists, said: "Pharmacists are experts in drug use and they know exactly how to use the drug. They are instructing doctors on how to use the drug, because there are many doctors who do not understand the drug and do not know how to prescribe it. ”
In response, the FDA responded: "This decision is based on several factors, including assessing the side effects of the drug and evaluating the interactions between the drugs. In addition, the hospital also needs to assess the patient's physical condition can not use the drug, if the patient does not evaluate the use of the drug, may cause the patient's physical function decline or even death. ”
It is reported that studies have shown that monubiravir may have greater side effects, so it is not recommended for pregnant women or children. Paxclovir, while less side-effect, interacts with a range of medications that treat blood pressure, cholesterol and many widely used medications, meaning that patients who want to take paxclovir must suspend other medications.
U.S. government orders doubled, and the company authorized imitation
U.S. President Joe Biden has reportedly announced that he has doubled his order for Paxlove, from 10 million to 20 million, and will be delivered in the coming months. According to foreign media, these 20 million courses of COVID-19 oral drugs can eventually reduce the hospitalization of at least one million people. However, because the United States did not pre-order these drugs in large quantities as they did when the vaccine was launched, it faced the problem of tight supply and long production time, and foreign media expected that most drugs would not be delivered on time within a few months.
Infographic
The price of the drug is also an important issue. It is reported that the average selling price of paxclovir is $529 (about 3378 yuan) per course of treatment, and the average price of monubiravir is about $709 per course of treatment. Not a small number for low-income countries.
The World Health Organization (WHO) reportedly said it is working to give low-income countries access to ORAL COVID-19 medication for $10 per course of treatment. Last October, monopilavavir producer Merck reached a treatment licensing agreement with the United Nations that would waive patents in 105 low- and middle-income countries around the world to allow them to produce generic drugs. Pfizer's official website also revealed that the company has reached a voluntary licensing agreement with the United Nations-backed public health organization "Drug Patent Pool" (MPP).
On January 20 this year, MPP announced agreements with 27 companies to produce and supply monupiravir to 105 low- and middle-income countries around the world, including five pharmaceutical companies from China.
It is reported that on January 4, an Indian pharmaceutical company announced the launch of a generic drug of monupiravir, priced at 35 rupees per capsule, and the total cost of a course of treatment is 1400 rupees (about $18.77). However, the head of the Indian Medical Research Council later said that due to the serious safety hazards of monubiravir, there was no final decision on whether to recommend the drug.
Red Star News reporter Fan Xu Intern reporter Li Jinrui
Edited by Zhang Xun
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