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Pfizer-BioNTech’s covid-19 vaccine will arrive this Monday morning at hospitals and other inoculation sites in the United States, ready to be injected into millions of people from the most vulnerable sectors, a senior official announced this Saturday.
(Also read: 13,000 deaths and 700,000 infections: the worst day of the pandemic)
The doses will begin to leave this Sunday from the Pfizer factory in Kalamazoo, Michigan (north), stored in boxes with dry ice capable of being kept at -70 degrees Celsius (-94 degrees Fahrenheit), the temperature needed to maintain it.
Under the agreement between Pfizer and the US government, within the Operation Speed of light to obtain therapies against covid in record time and that has dedicated more than 10 billion dollars to the anticovid vaccine, the pharmaceutical company will provide 100 million doses of its vaccine until March free of cost to Americans.
General Gus Perna, who oversees the massive logistics operation as part of the government’s anti-pandemic strategy, likened the moment to D-Day, the turning point of World War II.
“I am absolutely 100% sure that we are going to safely distribute this precious product, this vaccine necessary to defeat the enemy covid,” he told reporters.
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The news comes when the pandemic hits the country with more force. The United States is the most mourning country in the world, with nearly 300,000 deaths from covid-19 and almost 16 million infections.
In the last two weeks, the United States has exceeded 2,000 daily deaths related to the new coronavirus several times, figures similar to the worst peaks of the first days of the pandemic.
Perna said hundreds of sites, including hospitals and other distribution centers, will receive the vaccines between Monday and Wednesday, which would cover the first phase of vaccination, with about three million people immunized.
The country’s health authorities recommended that health workers and nursing home residents have priorityBut the decisions will be left to the state governments.
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We are going to safely distribute this precious product, this vaccine necessary to defeat the enemy covid
The distribution plan
Perna assured that the first vaccines will reach some of the around 600 vaccination points established by the states on Monday morning and since then a “constant distribution cadence” of vaccines will be maintained to reach 40 million doses at the end of this month.
“Right now (the vaccines) are being packaged and will start coming out tomorrow morning (Is Sunday) from manufacturing facilities “added the uniformed man.
Attention this Saturday was on the Pfizer factories in Michigan and Wisconsin, where the first trucks were seen to transport the ultra-cold freezers.
Hospitals in all 50 states have already prepared the freezing chests where they will store part of the 2.9 million doses It is expected that they will be distributed in the first week and that they will go first to inmates and workers in nursing homes.
The FDA authorized the use of the drug for people over 12 years old who have tested positive for covid-19 and are at risk of developing a severe case of the disease.
The complex process was outlined on Friday night in broad strokes in a message from the President, Donald Trump, to the nation and requires collaboration between Pfizer -which has created ultra-cold boxes with GPS tracking technology and temperature control-, the large US logistics operators Fedex and UPS, the Armed Forces, state health officials and finally hospitals and pharmacies that will administer the injections.
The logistical challenge is even greater considering that after three weeks a second injection should be given to ensure immunity that has been recorded in clinical trials.
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However, it is expected that this first batch of vaccines will not be sufficient for all states, which have the authority to distribute within the priority groups created by the Centers for Disease Control (CDC), although it is expected that the next week the candidate of the modern pharmaceutical company will be incorporated into the set of authorized immunizations.
States such as New York hope to vaccinate all their residents and employees in nursing homes for the rest of the year, to proceed immediately afterwards to inject medical and emergency personnel who are on the front lines of the fight against this pandemic that has left almost 300,000 dead in this country, more than in any other nation in the world.
In parallel, the medical centers and pharmacies that will participate in the vaccination campaign have started a race to be well supplied with dry ice, syringes, alcohol, dressings and even medicines to respond to possible anaphylactic attacks such as those registered in the first vaccination days in the United Kingdom.
“We are ensuring that we maintain the cold chain at all times and that CDC management guidelines are followed. In the past we have been able to maintain that cold chain in rural areas or complicated places like Africa and we believe it will work without major complications, “said Dr. Peter Marks, head of the committee that approved the vaccine.
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The director of the Food and Drug Administration (FDA, for its acronym in English), Stephen Hahn, said they work “as fast as we can, but the main priority is to maintain the integrity of the scientific process.”
Hahn acknowledged that there may be doubts and concerns about the vaccine, but assured that The entire approval process has been done in a transparent and rigorous manner.
Next week the FDA will review Moderna’s application for authorization of the vaccine. If that pharmaceutical company joins the distribution operation, the quantities of doses available to face the pandemic and the ease of transporting them will increase significantly.
Next week the FDA will review Moderna’s application for authorization of the vaccine.
The first approved vaccine
The United States became the sixth country, after Saudi Arabia, Bahrain, Canada, Mexico and the United Kingdom, to give the green light to the Pfizer / BioNTech vaccine on Friday night.
It was a triumphant moment for the American giant and its German partner BioNTech, who started work on their product, based on the experimental technology of mRNA (messenger ribonucleic acid), only 11 months ago.
Although the approval of the vaccine was already awaited, it came amid controversy. US media reported that President Donald Trump called the head of the US Food and Drug Administration (FDA) to threaten to fire him if he did not give the vaccine emergency approval on Friday.
(Also read: United Kingdom recommends not vaccinating against covid-19 to severe allergies)
This Saturday, the commissioner of the FDA, Stephen Hahn, denied this information before journalists: “The statements in the press that they threatened to fire me if we did not do it before a certain date are inaccurate.”
In a clinical trial with 44,000 volunteers, the vaccine proved to be 95% effective in preventing covid-19, and there is no evidence of serious side effects. But after two cases of serious allergies reported in the UK this week, the FDA advised against the vaccine to patients who have already had “severe allergic reactions” to its components or similar vaccines.
If any patient receives the first dose and has a severe allergic reaction, it is advised not to take the second dose.
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The FDA has not made a final decision on whether pregnant women or the immunocompromised should receive the injections., inviting people in these conditions to make the decision with their doctors.
“There weren’t enough pregnant women in the trials, or women who got pregnant in the trials to really know, and make any statement about it,” said FDA scientist Peter Marks.
Marks also expressed your support for Pfizer’s plan to allow people who participated in the clinical trial to find out whether they received the vaccine or the placebo.
Under this proposal, if they received the placebo they can request the vaccine when it is their demographic turn.
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Some scientists have objected to this plan because if trial participants find out what substance was given to them, they could change their behavior and this would corrupt the trial data. But for Marks, it is necessary to “balance the amount of blind data we receive with the need to protect people from a pandemic that is taking thousands of lives daily.”
AFP and EFE
