The Trump administration has doubled its orders to Pfizer and Modern this month to 200 million doses. But both vaccines are given as two doses per person, i.e. U.S. The supply alone will cover 200 million of the country’s 250 million adults. Authorizing more vaccines for emergency use can increase those reserves immediately, while also helping to ensure adequate vaccination when inoculation is allowed for adolescents and children.
Johnson and Johnson are preparing to publish the first efficacy data on its shots, which will be given as a single dose in January. AstraZeneca could also release more data early next month from its end-phase trial, officials with the federal government’s Operation Operation Speed Speed recently said. (The company said in a statement that it had “no further improvements regarding the U.S. special trial.”)
AstraZeneca, ranked first in the global vaccine race, has sold more shots worldwide than any other manufacturer. Between agreements with the World Health Organization, Alliedic for Epidemic Preparedness and Innovation and India’s mass-produced serum institute, the British drugmaker has promised to give other countries about 1 billion shots – including U.S. With 300 million euros pledged.
The AstraZeneca vaccine is much cheaper than others and is much easier to store and store in a vessel than a Pfizer-like vaccine, which requires an over-cold freezer or dry ice. He called it the U.S. Makes it an attractive option for low-income countries with easy-to-reach areas, as well as less advanced infrastructure.
Last month, AstraZeneca reported that nearly 1,000 trial volunteers in the UK were accidentally given the first dose of half-strength, but the company’s outlook for the vaccine is soft. Initial data showed the practice to be 90 percent effective, beating the two standard doses by 62 percent. Some vaccine experts believe that low-dose success could be a statistical fluke, as a small fraction of the thousands of people registered in the company’s trials are 3,000; Others say it could clearly suggest a better option.
Emergency Strazeneka still has to thoroughly inspect the lower dosing regiment before applying to the Food and Drug Administration for authorization for emergency use. The agency also requires that drug companies follow up with at least half of the trial volunteers after their last dose.
A company spokesman said “there is nothing to share at this time on US filing plans.”
Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, said the FDA’s minimum criteria for obtaining authorization do not tell the full story of the value of the vaccine.
“Early effectiveness in the first two months is just one of the many aspects that need to be considered,” said Hotz, who is developing a potential coronavirus start with partners in India. “Other vaccines can benefit in terms of protection, sustainability, sustainability. Safety, fitness for children or adolescents, and for that we will need additional vaccines.”
Pfizer and Moderna have only recently begun studying their vaccines in children younger than 12 years, and no manufacturer has begun testing even in young children. Regulators have also demanded more information on pregnant women and risk factors such as heart disease, diabetes and other diseases affecting the immune system. Health experts say a vaccine that can only work moderately overall may be best for key sub-populations, such as pregnant women.
And there are still some vaccines in development that may prove easier to manufacture, transport or operate than Pfizer and Moderna shots.
Both of those authorized vaccines use relatively new messenger RNA technology to instruct cells to make proteins found on viruses, which improve the body’s immune system. J&J and AstraZeneca use a more traditional method, in which small bits of DNA from a coronavirus are edited into a weaker version of another virus called adenovirus. When the adenovirus enters the cells, they read its DNA and produce the protein found in the coronavirus.
One theory about the AstraZeneca dosing dilemma is that the full dose of adenovirus stimulates a very large amount of the immune response – so the body didn’t have time to learn more about the coronavirus that it was defending, Remusen said. “It simply came to our notice then [AstraZeneca] He can begin the assessment of the half-dose method. “
But AstraZeneca data may represent variations for the FDA’s independent vaccine advisory panel, which is getting publicly to discuss each candidate to increase transparency and public confidence. The company said the combined results of the third phase of testing so far show its vaccine is 70 percent effective. But the two dosing regimens tell different stories: 90 percent are basically comparable to an existing vaccine; Not 62 percent.
“You can’t combine data from two different dosing strategies, two different dosing intervals and two different placebo groups,” said Paul Fit Fitness Advisory Committee of the University of Pennsylvania, which sits on the FDA’s expert panel, vaccines and related biological products.
It also presents a sticky situation for the largest national vaccination scheme in history. While two authorized vaccines now have almost identical efficacy and safety profiles and use the same technology, having a more diverse roster of vaccines would be difficult to distribute fairly.
“There are clear ethical issues: if one vaccine is more effective than another, who gets what, right?” Philip Landing, director of the global public health program at Boston College, stressed the importance of clear federal planning if that happens. “Another advantage of transparency and openness is apart from ensuring that the system works well – it can persuade people who are reluctant to get vaccinated.”
