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J&J, AstraZeneca resuming trials of vaccines [Video]

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Two trials involving coronavirus vaccine candidates are resuming. AstraZeneca has restarted the U.S. trial of its experimental COVID-19 vaccine, and Johnson & Johnson is set to resume its trial on Monday or Tuesday.

AstraZeneca said Friday the U.S. Food and Drug Administration has deemed it safe to continue testing the vaccine. The company had to pause its U.S. trial last month after a report of a serious neurological illness in a participant in its trial in the UK.It is developing its vaccine with researchers at Oxford University.

Johnson & Johnson said Friday that the independent safety panel, the Data and Safety Monitoring Board, has recommended that it resume trial recruitment after finding no evidence that the vaccine caused a volunteer to fall ill. The company says it’s on track to produce trial data of the vaccines’ effectiveness by the end of this year or early 2021.

Both companies have contracts to supply vaccines to the U.S. and other governments if they are cleared by regulators.

Video Transcript

– Two trials involving coronavirus vaccine candidates are resuming. AstraZeneca has restarted the US trial of its experimental COVID-19 vaccine, and Johnson & Johnson is set to resume its trial on Monday or Tuesday.

AstraZeneca said Friday, “The US Food and Drug Administration has deemed it safe to continue testing the vaccine.” The company had to pause its US trial last month after a report of a serious neurological illness in a participant in its trial in the UK. It is developing its vaccine with researchers at Oxford University.

Johnson & Johnson said Friday [? that, ?] “The independent safety panel, the Data and Safety Monitoring Board, has recommended that it resume trial recruitment after finding no evidence that the vaccine caused a volunteer to fall ill.” The company says it’s on track to produce trial data of the vaccine’s effectiveness by the end of this year or early 2021.

Both companies have contracts to supply vaccines to the US and other governments if they are cleared by regulators.

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AstraZeneca, J&J resuming US tests of COVID-19 vaccines

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Two drugmakers announced Friday the resumption of U.S. testing of their COVID-19 vaccine candidates.

Testing of AstraZeneca’s vaccine candidate had been halted since early September, while Johnson & Johnson’s vaccine study was paused at the beginning of last week. Each company had a study volunteer develop a serious health issue, requiring a review of safety data.

The two coronavirus vaccines are among several candidates in final-stage testing, the last step before seeking regulatory approval.

The drugmakers said they got the go-ahead Friday from the Food and Drug Administration to restart tests in the U.S.

Such temporary halts of drug and vaccine testing are relatively common: In research involving thousands of participants, some are likely to fall ill. Pausing a study allows researchers to investigate whether an illness is a side effect or a coincidence.

Testing of the AstraZeneca vaccine, developed with Oxford University, has already resumed in the United Kingdom, Brazil, South Africa and Japan.

“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” Pascal Soriot, AstraZeneca’s CEO, said in a statement.

AstraZeneca’s study involves 30,000 people in the U.S., with some getting the vaccine and others a dummy shot.

Testing was stopped after one British participant developed severe neurological symptoms consistent with a rare inflammation of the spinal cord called transverse myelitis. AstraZeneca testing had also been paused earlier in the summer.

Johnson & Johnson said it’s preparing to resume recruitment soon for its U.S. vaccine study. In a statement, the company didn’t disclose the nature of the volunteer’s illness but said a thorough evaluation “found no evidence that the vaccine candidate caused the event.”

The company added that it’s in talks with other regulators around the world to resume testing in their countries.

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Follow Linda A. Johnson on Twitter: @LindaJ_onPharma

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The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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Wallingford Criticized For Resuming In-Person Council Meetings

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WALLINGFORD, CT — A “large portion” of Wallingford’s coronavirus cases in October came from a single event in town, according to Health Director Stephen Civitelli.

In an update to the Town Council this week, Civitelli said health officials were able to contact trace the confirmed COVID-19 cases to the event and found there were relationships with multiple people that also ended up impacting schools.

Civitelli provided the update at Tuesday night’s meeting, which was the first in-person Town Council meeting since April because of the coronavirus pandemic. The decision to resume in-person council meetings was criticized by several people on the Wallingford Patch Neighbor Post page and a speaker at the meeting.

Coronavirus cases have been on the rise in Wallingford in October. There were 20 confirmed cases as of Oct. 13, compared to 33 cases in September, 24 in August and 18 in July.

There were 1,928 tests conducted from Sept. 26 to Oct. 3 with a positive test rate of .7 percent, according to Civitelli.

Phase 3 of the state’s reopening, which increased indoor restaurant and personal service capacity from 50 to 75 percent, began Oct. 8 and Civitelli said health officials are trying to monitor reopenings with the cases and “how we react to that as a community.”

“We’re trying to monitor everything as best we can to try and get a grasp on where cases are and get to those quickly, so that we can identify the situation and try to isolate the people before it becomes a greater issue,” Civitelli said.

Civitelli, who was appointed this week to Gov. Ned Lamont’s Vaccine Advisory Group, compared Wallingford’s case rate to two cities that were recently assigned a “Red” alert level for the state’s coronavirus warning system. Towns in the red threshold have the option to scale back to the state’s second reopening phase.

Based on a new case rate per 100,000 population, New London had a 14-day rolling average of 30.5, Norwich was 46.9 and Wallingford was at 3.7, according to Civitelli.

The school district notified parents several times within the past week of confirmed COVID-19 cases at five different schools. Councilor Chris Shortell asked Civitelli if there is a concern about the school system.

Civitelli said “not at this point” because contact tracing showed the cases originated from within the community and were not spread from students in the same cohort at school.

“If we’re identifying where everything is coming from, that’s a good thing,” Civitelli said. “It’s when I can’t wrap my arms around it, and there’s no way where I can trace it back, then that’s where we’re back in April and early May where it was just so widespread. At that point, then you have true community spread. As of right now, it seems like it’s fairly steady.”

In-person meetings resume in Wallingford

Council Chairman Vincent Cervoni opened the meeting saying it was “appropriate” for the council to resume in-person meetings.

“In the past month, children of Wallingford have returned

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