The first Covid vaccines were triumphs. What if the next are only OK?
The country's first two coronavirus vaccines have exceeded the expectations of scientists and health officials, with around 95 percent effectiveness and no major safety concerns.
But there aren't enough doses to get around - and if the next vaccines in the pipeline are all good instead of great, they could be a heavy sell to a skeptical public.
Vaccine makers AstraZeneca and Johnson & Johnson stand ready to release safety and efficacy data from late-stage studies as early as January, according to federal health officials. However, there are already signs that AstraZeneca's shot could lag well behind Moderna and Pfizer's existing vaccines. Early data released in November showed that the AstraZeneca vaccine was only 62 percent effective at the intended dose.
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Scientists and public health experts fear that faced with an option that is vastly different from others, consumers could turn down a less effective vaccine - even if it is the only one available to them. Surveys show that nearly 40 percent of adults in the US are reluctant to take a Covid-19 vaccine. Anything adding to that hesitation could jeopardize the country's ability to achieve herd immunity and end the pandemic.
"Nobody will want [the AstraZeneca] vaccine compared to the Pfizer and Moderna vaccines," said Angela Rasmussen, a virologist at the Georgetown Center for Global Health Science and Security, if its effectiveness stays at 62 percent in the final trial data.
However, Rasmussen and other health experts say the next wave of vaccines doesn't have to meet the 95 percent effectiveness mark set by Moderna and Pfizer to be valuable. They argue that real factors such as ease of shipping, storage, or public attraction of one dose instead of two can make a moderately potent vaccine worthwhile.
"We are facing a pandemic and perfect cannot be the enemy of good," said Leana Wen, a former Baltimore health commissioner and emergency doctor. “Yes, we want everyone to have something that is most effective. But when it comes to getting the most effective or nothing at all, we should choose the one that offers some level of protection. "
And the global assumptions of mass vaccination in 2021 - including the Trump administration's promise that every American can get a vaccine by the summer - are heavily dependent on a second and even third wave of vaccines hit the world market.
The Trump administration doubled its orders from Pfizer and Moderna to 200 million cans each that month. However, both vaccines are given in two doses per person, meaning US supplies only cover 200 million of the country's 250 million adults. The approval of additional vaccines in case of emergency could increase this supply immediately and also help ensure an adequate vaccine if vaccination is allowed for adolescents and children.
Johnson & Johnson is preparing to publish the first efficacy data for its single-dose shot in January. AstraZeneca could also release more data from its late-stage trials as early as next month, officials from Operation Warp Speed recently told the federal government. (The company said in a statement that it had "no further updates to the US-specific study.")
AstraZeneca is a pioneer in the global vaccine race and has sold more shots worldwide than any other manufacturer. Between agreements with the World Health Organization, the Coalition for Epidemic Preparation and Innovation, and the Serum Institute, a mass producer in India, the British drug maker has promised other countries nearly 1 billion shots - not including the 300 million it promised the US.
AstraZeneca's vaccine is far cheaper than others and much easier to ship and store than vaccines like Pfizer's, which require ultra-cold freezers or dry ice. This makes it an attractive option for hard-to-reach areas in the US, as well as for lower-income countries and less advanced infrastructure.
However, the outlook for the company's vaccine is bleak after AstraZeneca reported last month that nearly 3,000 volunteers in the UK were accidentally given a first half-strength dose. The regimen was found to be 90 percent effective in early data, outperforming the 62 percent effectiveness of two standard doses. Some vaccine experts believe the success of the lower dose could be a statistical coincidence, since 3,000 people are a small fraction of the tens of thousands of people who participate in the company's studies. others say it might indicate a much better option.
AstraZeneca would need to fully test the lower dosing regimen before applying for emergency approval from the Food and Drug Administration. The agency also requires pharmaceutical companies to follow at least half of the subjects for two months after their last dose.
A company spokesman said "there is currently nothing to report on US filing plans".
However, the FDA's minimum criteria for applying for approval do not provide any indication of the worth of a vaccine, said Peter Hotez, virologist and dean of the National School of Tropical Medicine at Baylor College of Medicine.
"Initial effectiveness in the first two months is just one of several things to consider," said Hotez, who is also developing a potential coronavirus shot with partners in India. "Other vaccines may offer advantages in terms of durability of protection, tolerance and safety, suitability for children or adolescents, and for that we need additional vaccines."
Pfizer and Moderna have only recently started testing their vaccines in children as young as 12 years old, and neither manufacturer has started testing in children who are younger. Regulators also asked for more data on pregnant women and certain risk factors like heart disease, diabetes, and other diseases that could affect the immune system. Health experts say a vaccine that may be modest overall is best for key subpopulations like pregnant women.
Some of the vaccines that are still under development may be easier to manufacture, transport, or administer than the Pfizer and Moderna vaccines.
Both approved vaccines use relatively new messenger RNA technology to instruct cells to make a protein found on the virus, which helps boost the body's immune system. J&J and AstraZeneca use a more traditional method that converts small pieces of DNA from the coronavirus into a weakened version of another virus called adenovirus. When the adenovirus enters cells, they read its DNA and produce a protein that is found in the coronavirus.
One theory about the AstraZeneca dosage confusion is that a full dose of the adenovirus triggered too large an immune response - so the body didn't have time to learn much about the coronavirus it was supposed to protect against, Rasmussen said. "It's still valuable to have this information because maybe [AstraZeneca] can start evaluating that half dose."
However, the AstraZeneca data could pose a dilemma for the FDA's independent vaccine advisory panel, which has met publicly to discuss each candidate in an effort to increase transparency and public trust. The company said the combined results of its Phase III studies show the vaccine is 70 percent effective. The two dosage regimens tell different stories, however: 90 percent is basically comparable to the vaccines available; 62 percent is not.
"Data from two different dosing strategies, two different dosing intervals, and two different placebo groups cannot be meaningfully combined," said Paul Offit, University of Pennsylvania vaccines expert who sits on the Advisory Committee of the FDA on Vaccines and Related Biological Products.
It also highlights a difficult situation for the largest national vaccination schedule in history. While the two now approved vaccines have nearly identical efficacy and safety profiles and use the same technology, it would be more difficult to distribute a more diverse list of vaccines fairly.
"There are obvious ethical problems: if one vaccine is more effective than the other, who gets what, right?" said Philip Landrigan, director of the global public health program at Boston College, who stressed the importance of clear federal planning when this happens. "Transparency and openness have another advantage that not only ensures that the system works well - it could convince people who are reluctant to receive the vaccine."
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