What that you must find out about close to US debut recordings
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Help is on the way.
This week, two companies released more news about their Covid-19 vaccines as they prepared to seek regulatory approval. This was a sign of hope that the US could soon have more weapons against the pandemic. But with fresh reasons to be hopeful, there have also been signs of caution as the as-yet-unapproved vaccines appeared to be less effective against some fast-spreading strains of the virus.
Biotech company Novavax announced Thursday that its vaccine was more than 89% effective against the disease in its Phase 3 clinical trial conducted in the UK. And Johnson & Johnson added on Friday that its single-dose shot was 66% overall effective against Covid-19.
The introduction of two more vaccines could significantly strengthen the global arsenal of tools to fight the virus and end the pandemic. And although J & J’s vaccine appears to be significantly less effective than Moderna and Pfizer-BioNTech’s at preventing disease, officials said it was still effective enough to prove useful, and the fact that only one shot is required is a clear advantage.
As more vaccines come into the fight, here are a few things you need to know to prepare for your shot:
1. Who can be vaccinated?
Pfizer’s vaccine was approved by the Food and Drug Administration for use in people aged 16 years and over, while Moderna’s vaccine was approved for people aged 18 years and over.
J & J’s vaccine has not yet been approved. The company is expected to file an application for emergency clearance with the US agency next week. The FDA review process is expected to take a few weeks, and the vaccine could be distributed in the US as early as next month.
Meanwhile, it is not known when the Novavax vaccine will be approved for use in the United States. The Phase 3 study, the results of which were published Thursday, was conducted in the UK and it is unclear whether this will be sufficient for approval in the US. The company began a late-December litigation involving 30,000 people in the United States and Mexico.
Given the limited supply, states are rationing doses to those considered the most vulnerable and essential to society. While state guidance does exist as to who should get the shots first, many states set their own course. With the slower than expected introduction, the federal government asked the states to open the authorization to all over 65-year-olds.
2. When does the supply increase?
According to the Centers for Disease Control and Prevention, more than 48.4 million doses of vaccine have been distributed in the United States to date. Given that the two vaccines currently approved are two-dose vaccines, it would take the US more than 660 million shots to vaccinate the entire public with the vaccines currently available.
Earlier this week, President Joe Biden announced plans to purchase an additional 200 million doses of the vaccines, including 100 million from Moderna and 100 million from Pfizer. That would bring the total supply of these two vaccines in the US to 600 million doses, but companies are still working to speed up production. Pfizer has announced it will ship 120 million doses and Moderna has promised 100 million by April.
J & J’s launch of the one-shot vaccine next month could boost supply in the U.S., which ordered 100 million doses from J & J by the end of June. Novavax has agreed to ship 100 million doses of its vaccine in the US if approved.
3. Are the vaccines effective against new variants?
Manufacturers and the US government are investigating how effective the current vaccines are against new variants of the virus. One variant in particular, strain B.1.351, which is dominant in South Africa, gives health authorities cause for concern.
The global studies of the Novavax and J&J vaccines provide clues as to how these vaccines will fare against new strains. Novavax said its vaccine was only 49% effective in 44 Covid-19 cases in South Africa, with 90% of the cases linked to the problematic new variant. And J&J said his vaccine was 57% effective in the South African arm of his study.
Dr. Paul Offit, a member of the FDA’s Advisory Committee on Vaccines and Related Biological Products, told CNBC that the new strains weren’t a big problem yet, but it was important that drug manufacturers prepare for the possibility that the virus could mutate enough to to evade the protection of current vaccines.
“Prepare for it. Sequencing these viruses. Be ready in case a variant comes up that is resistant to the vaccine,” he said.
Both Pfizer and Moderna have already announced that they are working on a booster shot for their vaccines that will better withstand strain B.1.351.
4. Are some shots better than others?
The first two vaccines approved in the US set a high standard for the others. Pfizer’s data showed that the vaccine was 94% effective at preventing the disease, while Moderna was 95% effective.
J&J said its vaccine was 72% effective at preventing the disease in the United States, but added that it was 85% effective at preventing people with Covid-19 from getting seriously ill. White House Health Advisor Dr. Anthony Fauci, later on Friday, noted that the main finding from the J&J vaccine data is that the single shot can keep people out of hospitals and prevent serious illness.
“The first thing people do is compare a 72% effectiveness with the 94% to 95% effectiveness previously reported in other studies. That’s true,” Fauci said at a White House news conference Friday, adding In addition, the more important number to consider is its 85% effectiveness in preventing serious diseases.
“The most important thing – more important than preventing someone from getting a pain and a sore throat – is to prevent people from getting a serious illness,” Fauci had previously said on a call to reporters. “That will ease so much stress and human suffering and death in this epidemic.”
However, because supply is limited and appointments are hard to come by, public health professionals are encouraging people to accept the vaccine they have available instead of waiting for the vaccine of their choice.
“I don’t think we should make choices in a public health crisis,” said Dr. Carlos del Rio, professor at Emory University School of Medicine. “I think in a public health crisis, take what’s there.”
5. What can you do in the meantime?
As the supply of vaccine doses increases and new players enter the fray, many Americans will still not get a shot for months. Health officials are urging people in the meantime to take steps to reduce the spread and prevent new strains of the virus from developing.
Viruses are like nature’s artificial intelligence, William Haseltine, president of the ACCESS Health International think tank and former professor at Harvard Medical School, told CNBC. As the virus spreads, it makes large numbers of copies of itself, and each version is a little different from the previous one.
With these copies, the virus can adapt to its environment. As they spread, they can learn how to better penetrate humans and make themselves more transmissible, like the worrying variants first reported in the UK, South Africa and Brazil. This is one of the reasons global health experts have urged curbing the spread of Covid-19 through public health measures like social distancing, hand washing and wearing a face mask. This would give the virus fewer opportunities to mutate and take time before a vaccine can be introduced.
“This virus is telling us that if we don’t public health control it, we’ll have gone under for a few more years and maybe a lot longer. That’s a big message,” Haseltine said. “Don’t rely on the vaccines, don’t rely on the drugs. This virus can outsmart you.”
Dr. Jay Butler, CDC deputy director on infectious diseases, said Friday that current modeling suggests that 70% to 75% of people would need to be vaccinated in order for the population to achieve herd immunity. However, should a faster-spreading virus develop into the dominant strain, that percentage would likely rise to 85%, he said.
“As I look at the streets, I reiterate the importance of the ongoing work in community containment and the importance of using the vaccines that we have available now and in the near future,” Butler said in one of the Society for Infectious Diseases of America.