Solving COVID
February 5, 2021

New variants of the coronavirus are jeopardizing hopes of quashing the COVID-19 pandemic by the fall. But acting Food and Drug Administration head Dr. Janet Woodcock said Thursday evening that the U.S. is planning a rapid review process for booster shots that would target the new strains, among other strategies to beat back the quickly spreading variants and prepare for new ones that might render the current vaccines ineffective.

"With current vaccines, we feel that, against any variants we have seen we have a fair amount of confidence they will provide good protection," Woodcock said. However, "the situation could change" quickly, and "if variants emerge that the vaccines have poor efficacy against, we will need to go through these quickly," she added. "If the virus changes, we are getting prepared for that."

Full clinical trials of booster shots would take too long and face other impracticalities, Woodcock said, but they would still need to be evaluated for safety and efficacy by an independent expert advisory panel, preferably in a public hearing. The FDA expects to propose written guidelines in two to three weeks.

Woodcock did not speculate the point at which booster shots might be necessary. But Paul Offit, a University of Pennsylvania vaccine expert who sits on an FDA vaccine advisory board, told Politico that line will be "crossed when people who have been fully vaccinated with two doses of one of these [authorized] vaccines are nonetheless hospitalized with one of these variant strains." Offit and other vaccine experts suggest the U.S. gear up to fight COVID-19 like it does with the yearly flu, altering the foundational vaccine to tackle new mutations.

Several vaccine makers, including Moderna, are already preparing trials for COVID-19 booster shots. Peter Weber

10:47 a.m.

This week, with 2.8 million doses of the newly-authorized Johnson & Johnson COVID-19 vaccine in tow, 17.6 million coronavirus vaccine doses in total will be shipped out across the United States, a marked improvement from the 10 million doses the country was averaging just a month ago.

States are also getting those shots into people's arms more quickly now. On both Saturday and Sunday, more than 2.3 million received a vaccine dose, suggesting that at least 3 million people could be getting a shot daily by the end of March, The New York Times reports.

Now, there's cautious optimism among experts that herd immunity could be on the horizon, and the single-dose Johnson & Johnson shot appears to be a major reason why. Per Vox, if one-third of vaccines are one-shot and the U.S. is administering 3 million doses per day, the U.S. could reach 80 percent immunity by mid-summer.

The Mayo Clinic's Vincent Rajkumar estimates that, at this point, around 140 million people will need to be vaccinated to reach herd immunity, a goal he predicts could be achievable within three to four months. Rajkumar said his estimate is likely conservative since the actual number of people who have already been infected is probably much higher than what's been recorded.

There are several caveats, including lingering vaccine hesitancy and uncertainty over variants' ability to resist immunity, but the U.S.'s much-maligned vaccine rollout looks to be on the upswing. Tim O'Donnell

February 27, 2021

The Food and Drug Administration on Saturday authorized Johnson & Johnson's single-dose COVID-19 vaccine for emergency use, which means there will soon be three effective shots available for Americans.

The Johnson & Johnson candidate registered a 72 percent efficacy rate in the U.S. clinical trial. That falls short of the roughly 95 percent rates seen in the Pfizer-BioNTech and Moderna trials, but, The New York Times notes, experts are still very pleased with Johnson & Johnson's results, especially since it also showed 85 percent efficacy against severe COVID-19 infections, and 100 percent efficacy against hospitalizations and deaths, suggesting it will be a crucial tool in the fight to end the pandemic.

Dr. Anthony Fauci, the government's top infectious disease expert, told the Times people shouldn't get wrapped up in the numbers and instead "accept the fact that now you have three highly effective vaccines. Period." And Dr. Danny Avula, the vaccine coordinator for Virginia, said he's "super-pumped about this," adding that the lack of hospitalizations and deaths among vaccinated trial volunteers is "all I need to hear."

Plus, Johnson & Johnson's vaccine requires just one dose for full inoculation and can be stored at standard refrigeration temperatures for three months, which will help states speed up their vaccination drives and make distribution easier. All told, Johnson & Johnson has pledged to provide the U.S. with 100 million doses by June, but four million doses should be ready to go as soon as possible now that the FDA has signed off, with another 16 million available by the end of the March. Read more at The New York Times. Tim O'Donnell

February 25, 2021

The Pfizer-BioNTech COVID-19 vaccine was basically as effective in a study of 600,000 Israelis as in Pfizer's smaller clinical trials, researchers reported Wednesday in the New England Journal of Medicine. And the new study provided evidence Pfizer was unable to show, due to limited data in its trials, that the vaccine is equally effective in people 70 and over as in younger people.

The publisher results provide "scientifically validated real-world evidence of the effectiveness of the vaccine," said Ran Balicer, one of the study's chief authors and chief innovation officer at Clalit, Israel's largest health care provider.

The study compared 600,000 Israelis who had received the vaccine against 600,000 demographically similar Israelis who were not vaccinated. The vaccinated population was 57 percent less likely to develop any COVID-19 symptoms in the two to three weeks after getting the first dose and 94 percent less likely after getting the second shot. Those fully inoculated were 92 percent less likely to develop severe COVID-19 symptoms. One dose was 72 percent effective at preventing death.

"This is immensely reassuring," said the Mayo Clinic's Dr. Gregory Poland, who is not involved in the study, "better than I would have guessed." The Clalit Research Institute, Israel's Ben-Gurion University of the Negev, and Harvard University led the research.

Israel agreed to give Pfizer access to its data in exchange for extra vaccine supply, and it has now given more than half its population a first dose and fully inoculated about a third of the country. Its data is especially useful because Israel has now opened its vaccination campaign to everyone older than 16. This has also allowed Israel to experiment with the next stages of the pandemic. On Saturday, Israel began issuing special passports that allow vaccinated people access to concerts, gyms, hotels, and other public spaces. Peter Weber

February 24, 2021

Moderna announced on Wednesday it will begin testing a new version of its COVID-19 vaccine designed to target the coronavirus variant first reported in South Africa.

The pharmaceutical company said it has sent doses of the booster shot to the U.S. National Institutes of Health for clinical trials. In a statement, CEO Stéphane Bancel said Moderna is "committed to making as many updates to our vaccine as necessary until the pandemic is under control."

Moderna previously revealed that preliminary studies showed the vaccine still made neutralizing antibodies above protective levels for the South African variant, but because it was a reduced level, it prompted the company to begin tweaking the vaccine against the strain, as well as variants that first spread in the United Kingdom and Brazil.

Moderna is already conducting tests involving giving a third dose of its original vaccine as a booster to people who have received two doses, and the new clinical trials will evaluate the safety of the variant-specific booster and a "multivalent booster candidate" that is one dose of the variant-specific booster and original vaccine, NBC News reports. Catherine Garcia

February 24, 2021

The Food and Drug Administration appears to be closing in on an emergency use authorization for the single-dose Johnson & Johnson COVID-19 vaccine, which a large clinical trial has shown to be safe and effective. And the "most encouraging" aspect in the FDA's analysis may be the data that suggest the shot works in areas where highly contagious variants are spreading, like Brazil and South Africa.

The overall efficacy rate — that is, protection against any symptomatic infection — in the South African trial was lower than it was in the United States initially, but the numbers did start to even out over time, and after a month, the shot's efficacy rate against severe infections was 82 percent. The figures out of Brazil show a similar trajectory, though the efficacy rate against severe infections was actually slightly higher than in the U.S.

Of course, the trial data is not a guarantee of the vaccine's effectiveness in a real-world setting, but the FDA's breakdown should still help alleviate growing concerns that the so-called South African variant, especially, can completely resist vaccinations, an outcome that would add to the challenge of slowing the pandemic going forward. Tim O'Donnell

February 24, 2021

The United States could be days away from getting a third COVID-19 vaccine.

A Food and Drug Administration review has confirmed that Johnson & Johnson's COVID-19 vaccine, which only requires a single shot, is safe and effective, meaning it could be authorized for emergency approval "as soon as this weekend," The Washington Post reports.

The FDA review showed the vaccine was 66 percent effective at preventing moderate to severe COVID-19 in a large clinical trial, though it was 85 percent effective at preventing severe illness. As Johnson & Johnson previously announced, the vaccine also "demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination." That, University of Rochester School of Medicine and Dentistry's Nancy M. Bennett told the Post, is "really what's important."

The Johnson & Johnson vaccine comes with the key benefit of only requiring one dose, as opposed to two doses for both the Pfizer and Moderna vaccines that were previously authorized for emergency approval in the United States. Plus, the Johnson & Johnson vaccine can also be stored for three months in a refrigerator, rather than having to be kept frozen, The Associated Press notes.

A committee is set to meet Friday to consider whether the FDA should authorize the Johnson & Johnson vaccine for emergency approval. The company says that should the FDA do so, it expects to begin shipping the vaccine immediately and "deliver enough single-doses by the end of March to enable the vaccination of more than 20 million Americans." Brendan Morrow

February 24, 2021

COVAX, the World Health Organization program to equitably distribute COVID-19 vaccines to lower-income countries, delivered 600,000 doses of the Oxford-AstraZeneca vaccine to Ghana on Wednesday. It is the first batch of what COVAX hopes will be 2 billion doses for 92 countries by the end of 2021, and UNICEF and the WHO jointly described the delivery as a "momentous occasion" in the global fight against COVID-19.

Ghana, a West African nation of 30 million people, said Tuesday that it has recorded 81,245 COVID-19 cases and 584 deaths, though the actual number is believed to be higher. The country will start its vaccination campaign on March 2, starting with health care workers, people 60 and older, Ghanaians with underlying health issues, and frontline government officials and their staff.

COVAX has raised $6 billion but says it needs an additional $2 billion to meet its 2021 target. The AstraZeneca doses delivered to Ghana were made by the Serum Institute of India. Peter Weber

February 23, 2021

Pfizer/BioNTech and Moderna pledged Tuesday to boost their current distribution of COVID-19 vaccines.

As it stands, Pfizer and Moderna are distributing 4-5 million vaccine doses each week. Pfizer plans to up that to 13 million doses weekly by mid-March, and Moderna is working to distribute 40 million doses per month, the companies told the House Energy and Commerce Committee during a Tuesday hearing. Moderna plans to ship at least 100 million doses by the end of May.

The increased production promises come amid a sluggish coronavirus vaccine rollout. President Biden originally set the U.S. on a goal of distributing 100 million vaccine doses during his first 100 days in office, but increased it to 150 million as it became clear the original plan wouldn't allow the U.S. to achieve herd immunity for months. The U.S. gave out an average of 1.45 million vaccines each day in the week of Feb. 10-17, per the Centers for Disease Control and Prevention.

Both Moderna and Pfizer are currently testing booster shots that may work better against more transmissible COVID-19 variants. Moderna is testing its vaccine's efficacy on adolescents and hopes to distribute it to them by the fall. Kathryn Krawczyk

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