Moderna starts dosing tomorrow; Oxford will get British approval next week

Posted by Abhishek De | New Delhi |

Updated: December 20, 2020, 7:47:28 pm

Smear collection for the ongoing Covid-19 test in a mobile NMMC test facility in Vashi (express photo by Amit Chakravarty)

The United States got a big shot in the arm in the fight against Covid-19, according to the Food and Drug Administration (FDA). issued emergency permit (EUA) on a second vaccine against the novel coronavirus. The infection has claimed more than 316,000 lives in the country and continues to infect nearly 2 lakh daily.

Healthcare workers in the United States will be vaccinated with the Moderna mRNA vaccine on Monday – exactly one week later Pfizer-BioNTech’s vaccine was launched in the worst affected Covid-19 country. While the Pfizer vaccine needs to be stored at -70 degrees Celsius, a temperature much lower than standard freezers, the Moderna vaccine requires -20 degrees Celsius.

The University of Oxford’s AZD1222 vaccine, manufactured by AstraZeneca, is expected to receive regulatory approval in December for launch in early 2021, according to The Daily Telegraph. The development will be a confidence boost for India as the vaccine (called Covishield here) is manufactured in collaboration with the Serum Institute of India.

Coronavirus (Covid-19) vaccine status check:

Moderna Covid-19 vaccine

Moderna is expected to be the second company to start vaccinating the public as of Monday. The vaccine is already being distributed in more than 3,700 locations. An application for full approval is expected next year, Moderna said in a statement.

The vaccine was recommended by the Advisory Board to the United States Centers for Disease Control and Prevention (CDC) for use in people aged 18 years and over. However, the FDA has warned that the vaccine should not be given to anyone who has a history of severe allergic reaction to any component in the shot.

Moderna’s vaccine was found to be around 95 percent effective in preventing Covid-19, and it has provided compelling evidence that it can prevent severe cases of the infection. In addition, large-scale clinical studies did not show any serious long-term side effects.

Moderna expects to produce 20 million cans for the US by the end of the year and an additional 85 to 100 million cans in the US in the first quarter.

An RT-PCR test is being performed in New Delhi’s Trilokpuri (express photo)

Pfizer-BioNTech Covid-19 vaccine

More than 128,000 people in the US were given the Pfizer BioNTech vaccine this week when the FDA began investigating the reasons for five people who had allergic reactions to the shot. This prompted the U.S. Centers for Disease Control and Prevention (CDC) to warn that anyone who had a severe reaction to a Covid-19 vaccine should not be given the second dose.

This comes days after the UK regulator states that people with a history of anaphylaxis or severe allergic reactions to a medicine or food should not receive the Pfizer vaccine. Recently, a video of a passed out in Tennessee at a press conference after receiving the Pfizer shot went viral, raising further questions about the safety of the vaccine, which has now been approved in up to eight countries.

After the UK, Canada, Bahrain, the US, Mexico, Malaysia and Switzerland, Israel was the youngest country to start its vaccination campaign with the aim of vaccinating around 60,000 people a day.

COVID-19 vaccination guidelines CDC Sandra Lindsay, left, a nurse at the Long Island Jewish Medical Center, is led by Dr. Michelle Chester (AP) vaccinated with the Pfizer-BioNTech COVID-19 vaccine.

Oxford-AstraZeneca Covid-19 vaccine

According to Pfizer, the UK is expected to approve the Oxford vaccine by December 28 or 29, after final data is available on Monday, The Daily Telegraph reported. “The Oxford vaccine is expected to be approved within days of Christmas, creating a massive drive to shock millions of people in January,” the report said.

The AZD1222 vaccine will be the last of the front-runners to be approved, and regulatory assessments have taken between 62 and 90 percent longer due to differences in efficacy rates on separate dosing schedules.

However, Oxford University said earlier this week that the vaccine candidate had a better immune response when a two full dose regimen was used instead of a full dose followed by a half dose booster, citing data from Phase I / II trials. However, the latest details did not contain any reference to the late-stage interim results published two weeks ago.

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“Booster doses of the vaccine have been shown to produce stronger antibody responses than a single dose. The vaccine stimulates broad antibody and T cell functions, ”the university said in a statement.

If the UK grants regulatory approval it is likely to increase the vaccine candidate’s chances of obtaining the necessary approvals in India. The Serum Institute of India has announced that vaccination against Covid-19 is expected to begin in India in January and that the company that tests and manufactures the vaccine candidate Oxford-AstraZeneca is expected to receive emergency approval by the end of the month.

Johnson & Johnson Covid-19 vaccine

Johnson & Johnson, which lagged rivals Pfizer and Moderna Inc in the vaccine race, announced earlier this week that it had enrolled about 45,000 participants in a late-stage study of its single-dose candidate and is expecting interim dates by the end of January.

The company said a single vaccine would make it easier to distribute millions of doses compared to competitors like Pfizer, Moderna and Oxford who require two doses.

J&J also said it plans to file an emergency clearance application with the U.S. Food and Drug Administration in February if the data from the study are safe and effective. In October, J&J suspended the study for more than a week after a patient developed an “unexplained disease” during the study.

Separately, the company is running late-stage studies in the UK to test a two-dose regimen of its Covid-19 vaccine among thousands of volunteers.

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