The US issued the script to distribute Covid-19 vaccine in early November
The US Centers for Disease Control and Prevention (CDC) mapped out the Covid-19 vaccine approval scenario in November, with two presumptive "Vaccine A" and "Vaccine B" assumptions.
CDC has informed health officials in 50 states and five major cities, New York, Chicago, Philadelphia, Houston and San Antonio, preparing to distribute Covid-19 vaccinations to health workers and at-risk groups. highly infected muscle. The CDC's guidance is the latest indication of the US acceleration in the race to find ways to repel a pandemic.
Three relevant documents were sent out by the CDC on August 27, the same day President Donald Trump made at the Republican National Conference that the Covid-19 vaccine would be released this year.
The CDC outlines a detailed scenario of the distribution of two unidentified potential candidates, namely "Vaccine A" and "Vaccine B", each requiring two doses, spaced several weeks apart. The vaccination program is expected to be implemented in hospitals, clinics, and medical facilities. The Center gives out the necessary specifications, related to the transport, modulation and management.
These features seem to be consistent with the products of the Pfizer and Moderna pharmaceuticals.
Other requirements, including the required storage temperature, the time between injections, and the type of health center that can accommodate storage, also match what the two firms make about their products.
In the hypothetical scenario, the "candidate" from Pfizer is the same as "Vaccine A", which would release about two million doses. Products from Moderna meet the requirements of "Vaccine B", dispensing approximately one million doses.
The storage temperature of Pfizer products is minus 70 degrees Celsius, meaning it cannot be used in most small locations. Moderna's vaccine needs to be frozen at minus 20 degrees Celsius.
At the August 26 discussion of the Advisory Committee on Immunization Practices, Dr. Kathleen Dooling, CDC member, gave the following situations: Vaccine A (assuming vacicne Pfizer) or Vaccine B (presumed to be Moderna vaccine) approved. In the other case, both "candidates" received a nod from the medical agency.
The CDC document says that the injections will be provided free of charge to users. But if they are approved urgently instead of approved by current standards, the manufacturer will not be reimbursed administrative costs.
According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, if the results are positive, the vaccine can be dispensed before the completion of the clinical trial. Public health experts say that government agencies need to urgently prepare for the last big and complex effort to secure the vaccination of hundreds of millions of Americans.
The guide notes medical staff, long-term health care, and national security forces will be given priority. People 65 years of age and older, Native American citizens, of "ethnic minorities", at high risk of disease or severe progression are also given the vaccine first.
"This is a positive plan because it doesn't just focus on people living in the wealthy, high-income suburbs," said Dr. Cedric Dark, at Baylor College of Medicine in Texas.
In the guidance, the CDC also emphasizes: "Limited doses of Covid-19 vaccine may be released in early November". On the same day, Dr. Robert Redfield, CDC director, sent an open letter to the governors, asking them to prepare the distribution site by November 1.
The emergency approval plan has made many fear that the administration of President Donald Trump is urgently trying to distribute vaccines before the 3/11 election.
For a country struggling with the post-Covid-19 challenges, where health resources are fragmented, deficient, the provision of millions of injections is a major challenge, especially when they need to be preserved in standard temperature. Even the CDC guide assumes this scenario is only an assumption, based on the necessary conditions.
In Indonesia, many HIV patients have to take the amount of medication that is given for one month to two months, although this may affect their health.
The Nairobi blockade leads many patients to borrow drugs from relatives, mix or even quit, leading to a very high risk of resistance. Thomas Wouto, an HIV patient, has to borrow his wife's medicine.
Mexico's drug supply has expired. In Brazil, HIV and TB drugs are purchased and distributed by the Ministry of Health. At present, when all resources are concentrated on Covid-19, distribution and treatment are limited. Even when governments and private organizations buy drugs months in advance, global stocks could be depleted prematurely.
More than 80% of the world's supply of antivirals comes from India. Production costs can rise to about $ 225 million a year due to material shortages, labor, transportation and currency fluctuations, according to the United Nations AIDS Organization.
"We depend only on a few key developers and manufacturers. What needs to be done is to diversify the supply of important drugs," said Dr. Meg Doherty, WHO's HIV program director. price.
"The outlook for the Covid-19 vaccine is uncertain and continues to evolve, and it could change as more information becomes available," a CDC spokesman said.
Experts fear this process can hardly happen without any obstacles, due to last-minute competition.
"The timeframe in place seems a bit ambitious. There are only 30 days left until October," said Dr. Cedric Dark.
The clinical trial phase can last for many years if reliable results are desired. Padmini Pillai, an expert in vaccine research and immunology at the Massachusetts Institute of Technology, said that conclusions should only be made early if the product is very effective, the vaccinated person is completely protected from disease.
Significant risks can be exposed in a phase three trial when the vaccine is used in tens of thousands of people. At this time, rare but dangerous side effects will gradually appear. Researchers also need time to test on citizens from multiple countries to assess whether the product works across different ethnic groups or races.
The CDC document notes that public health officials should reconsider lessons learned from the 2009 H1N1 pandemic vaccination campaign. At that time, the amount of vaccine in the first place was not enough to meet national needs. .
Shu Linh (According to NY Times)
Linh Phan (Follow NY Times)