https://www.nytimes.com/2021/03/31/us/politics/johnson-johnson-coronavirus-vaccine.html

How One Firm Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile

An investigation by The New York Times found a hidden explanation: Government purchases for the Strategic National Stockpile, the country’s emergency medical reserve where such equipment is kept, have largely been driven by the demands and financial interests of a handful of biotech firms that have specialized in products that address terrorist threats rather than infectious disease.

Chief among them is Emergent BioSolutions, a Maryland-based company now manufacturing Covid-19 vaccines for AstraZeneca and Johnson & Johnson. Last year, as the pandemic raced across the country, the government paid Emergent $626 million for products that included vaccines to fight an entirely different threat: a terrorist attack using anthrax.

Throughout most of the last decade, the government has spent nearly half of the stockpile’s half-billion-dollar annual budget on the company’s anthrax vaccines, The Times found. That left the government with less money to buy supplies needed in a pandemic, despite repeatedly being advised to do so.

Under normal circumstances, Emergent’s relationship with the federal stockpile would be of little public interest — an obscure contractor in an obscure corner of the federal bureaucracy applying the standard tools of Washington, like well-connected lobbyists and campaign contributions, to create a business heavily dependent on taxpayer dollars.

New studies show that one shot of a vaccine can greatly amplify antibody levels in those who have recovered from the coronavirus.

In another new study, researchers at New York University found that a second dose of the vaccine did not add much benefit at all for people who have had Covid-19 — a phenomenon that has also been observed with vaccines for other viruses.

In that study, most people had been infected with the coronavirus eight or nine months earlier, but saw their antibodies increase by a hundredfold to a thousandfold when given the first dose of a vaccine. After the second dose, however, the antibody levels did not increase any further.

Dr. Krammer led another of the new studies, which showed that people who have had Covid-19 and received one dose of a vaccine experienced more severe side effects from the inoculation and had more antibodies compared with those who had not been infected before.

“If you put all four papers together, that’s providing pretty good information about people who already had an infection only needing one vaccination,” Dr. Krammer said.

Johnson & Johnson plans to test its coronavirus vaccine in infants and even in newborns, as well as in pregnant women and in people who have compromised immune systems.

The bold plan for expanded clinical trials met with the approval of Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the Food and Drug Administration advisory committee that reviewed the company’s vaccine data.

When Dr. Levy saw the outlines of the planned trials, “they turned my head,” he said. They were reported as part of the company’s application to the F.D.A. for emergency use approval and discussed at the F.D.A. meeting.

“They did not get into a lot of detail about it but did make it clear they will be pursuing pediatric and maternal coronavirus immunization studies,” Dr. Levy said. They referred committee members to their briefing materials where, on page 34, the company mentioned the planned studies.

https://www.nytimes.com/2021/02/28/world/johnson-and-johnson-vaccine-testing-children.html

The steady drumbeat of reports about new variants of the coronavirus — first in Britain, then in South Africa, Brazil and the United States — has brought a new worry: Will vaccines protect against these altered versions of the virus?

The answer so far is yes, several experts said in interviews. But two small new studies, posted online Tuesday night, suggest that some variants may pose unexpected challenges to the immune system, even in those who have been vaccinated — a development that most scientists had not anticipated seeing for months, even years.

The findings result from laboratory experiments with blood samples from groups of patients, not observations of the virus spreading in the real world. The studies have not yet been peer-reviewed.

But experts who reviewed the papers agreed that the findings raised two disturbing possibilities. People who had survived mild infections with the coronavirus may still be vulnerable to infection with a new variant; and more worryingly, the vaccines may be less effective against the variants.

(CNN)Scientists have identified an "escape mutant" that may decrease the efficacy of Covid-19 vaccines.
The mutation -- called E484K -- has been found in a variant of the coronavirus first spotted in South Africa two months ago. That variant has now spread to 12 other countries.
Penny Moore, associate professor at the National Institute for Communicable Diseases in South Africa, called the mutation "alarming."

We fear this mutation might have an impact, and what we don't know is the extent of the impact," she said.
E484K is called an "escape mutant" because it's been shown it might be able to escape some of the antibodies produced by the vaccine.
"I'm worried," said Alex Sigal, a virologist at the Africa Health Research Institute.
Sigal, Moore, and other scientists who are studying the E484K mutation still have to complete their work in the lab to see if the vaccine is less effective against this new variant.



https://www.cnn.com/2021/01/12/health/coronavirus-mutation-south-africa-variant/index.html