Solving COVID
February 3, 2021

Confidence in the University of Oxford and AstraZeneca COVID-19 vaccine seems to be growing. New analysis released this week suggests that not only does the vaccine protect against symptomatic COVID-19 infections, it could also significantly curb transmission, making it a potentially very effective tool for bringing the virus to heel.

The vaccine is affordable, easy to produce and store, and has been approved by health regulators in the United Kingdom, India, and Europe, as well as several other countries. But it has not yet been approved by the Food and Drug Administration in the United States, where it's still undergoing late-stage trials. That's led to some harsh criticism. The Mayo Clinic's Vincent Rajkumar called the delay a "huge blunder," while The Atlantic's Conor Friedersdorf described it as "the most profound impingement on my liberty I've faced." Writer Matthew Yglesias lamented a lack of pressure from lawmakers and the U.S. media for speedy approval.

For starters, AstraZeneca hasn't submitted any paperwork to the FDA, so, in short, it can't grant approval for what hasn't been requested, notes Axios' Sam Baker:

But there are more complex reasons behind the holdup. In the U.K., Business Insider notes, health regulators "rely more heavily on a company's data to make conclusions," whereas in the U.S., an independent advisory committee takes a look at data sets from both the FDA and drug companies before the FDA can make its final decision.

In this case, the FDA was concerned following a series of missteps by AstraZeneca, including the company's failure to alert the agency about a decision to halt trials after a U.K. participant fell ill in September, and a strange discrepancy and incomplete testing of promising — but mistakenly-administered — half-strength doses. There's speculation submission and approval will come in April, but until the U.S. gets clearer data, the vaccine will remain in regulatory limbo. Tim O'Donnell

March 2, 2021

President Biden's administration is reportedly set to unveil a "historic partnership" between Merck & Co. and Johnson & Johnson to manufacture the latter's COVID-19 vaccine.

Biden will announce on Tuesday that Merck will help make the Johnson & Johnson vaccine that recently received emergency approval from the Food and Drug Administration, a move that "could sharply boost the supply," The Washington Post reports.

"It’s a historic partnership," a Biden administration official told the Post, adding that the two competitors "recognize this is a wartime effort."

Under the partnership, Merck will dedicate two U.S. facilities to the effort, with one making the actual vaccine and the other helping with the "last stage of the production process during which the vaccine substance is placed in vials and packaged for distribution," the Post explains. Still, the Post reports it could take months to get these facilities up and running. FDA approval of the Johnson & Johnson vaccine was particularly anticipated because it only requires a single shot, unlike the previous two vaccines approved by the FDA.

The Biden administration reportedly took steps to broker such an agreement after it became clear that Johnson & Johnson was behind on vaccine production. The company has said it expects to have 20 million vaccine doses available by the end of March and 100 million by the end of June. Merck previously attempted to develop COVID-19 vaccines but had to abandon the effort due to inadequate immune responses.

Biden, according to CNN, is expected to discuss the partnership during remarks from the White House on Tuesday afternoon. Brendan Morrow

March 1, 2021

As the United States adds another COVID-19 vaccine to its arsenal and ramps up its distribution drive, potentially pushing the country closer toward herd immunity, concerns about vaccine hesitancy among the population remain. But overall, it seems, people are growing increasingly comfortable with getting a shot. Data from the KFF Vaccine Monitor shows 55 percent of Americans have either already received a vaccine dose or plan on getting one as soon as possible, Axios reports. For context, back in December only 34 percent of people said they were prepared for inoculation without hesitation.

The increase there appears to correlate with a decline in the number of people who are in the "wait and see" camp, especially because the number of surefire holdouts has remained steady. And even if folks in the latter group don't ever change their minds, Axios notes, herd immunity is feasible.

Additionally, while much has been made about hesitancy, driven by historical distrust in the U.S. health care system, among communities of color, Black and Latino Americans have rapidly and consistently joined the ranks of people who want a shot, polling conducted by Civiqs between November and February shows, per Axios. Overall, white Americans are now less likely to get vaccinated, and the stance is largely split along party lines. Tim O'Donnell

March 1, 2021

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

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