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Moderna Says Vaccine 100% Effective Against Severe Covid, Seeks Clearance

COVID-19 Vaccine: Moderna said it expects to have approximately 20 million doses of the vaccine, called mRNA-1273, available in the US by the end of the year.

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Washington: Moderna Inc will apply for US and European emergency authorization for its COVID-19 vaccine on Monday after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said. Moderna also reported that the vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people.

The filing sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorization this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate in trials. “We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna Chief Medical Officer Tal Zaks said.

“We expect to be playing a major part in turning around this pandemic.”

Of the 196 volunteers who contracted COVID-19 in the trial with more than 30,000 people, 185 received a placebo while 11 got the vaccine.

Moderna reported 30 severe cases — all in the placebo group — which means the vaccine was 100% effective in preventing severe cases.

“As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public,” said Alexander Edwards, associate professor in biomedical technology at Britain’s University of Reading.

In addition to filing its US application, Moderna said it would seek conditional approval from the European Medicines Agency, which has already begun a rolling review of its data, and would continue to talk with other regulators.

Pfizer has already applied for emergency use authorization in the United States and Europe, putting it about a week ahead of Moderna.

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.

Both of the vaccines use a new technology called synthetic messenger RNA (mRNA) whereas others, such as Britain’s AstraZeneca, are using more traditional methods to develop their vaccines.

AstraZeneca has announced an average efficacy rate of 70% for its shot and as much as 90% for a subgroup of trial participants who got a half dose, followed by a full dose.

But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.

Moderna’s latest efficacy result is slightly lower than an interim analysis released on Nov 16 of 94.5% effectiveness, a difference that Mr Zaks said was not statistically significant.

“At this level of effectiveness, when you just do the math of what it means for the pandemic that’s raging around us, it’s just overwhelming,” said Zaks, who said he cried when he saw the final results over the weekend.

Both the Moderna and Pfizer vaccines proved more effective than anticipated and were far superior to the 50% benchmark set by the US Food and Drug Administration (FDA).

The past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and comes as new infections and COVID-19 hospitalizations are at record levels across the United States.

Independent advisers to the FDA are scheduled to meet on December 17 to review Moderna’s trial data and make a recommendation to the FDA.

They will meet on December 10 to review Pfizer’s data. Shortly after gaining emergency use authorization, Moderna expects the vaccine to be shipped to distribution points throughout the United States by the government’s Operation Warp Speed program and McKesson Corp, a drug distributor contracted by the US government.

Its distribution is expected to be easier than Pfizer’s because while it needs to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer’s vaccine.

Moderna said the 196 COVID-19 cases in its trial included 33 adults over 65 years old and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants. There was one death related to COVID-19 in the placebo group.

Azra Ghani, chair in infectious disease epidemiology at Imperial College London, said Monday’s details from Moderna confirmed the vaccine was highly efficient, including against severe cases. “Whilst this does not exclude some risk of severe disease after vaccination given the relatively small number of severe cases, these results suggest very high efficacy,” she said.

Zaks said the vaccine has been developed during a period of “political acrimony” and having a highly effective vaccine may go a long way toward erasing some of that distrust. “This is as black and white as an effect on a population will be. Your chances of actually being sick if you’ve been vaccinated are decreased 20-fold,” he said.

Moderna reported no new side effects since its interim analysis. Based on that analysis, the most common side effects were fatigue, injection site redness and pain, headache and body aches, which rose after the second dose and were short-lived.

Zaks said the vaccine caused significant flu-like symptoms in some participants, which, he said, “goes hand-in-hand with having such a potent vaccine.” But it has not caused any significant safety concerns so far.

Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another in even younger volunteers early in 2021.

It hopes to have the vaccine available for adolescents by September, Zaks said.

Other vaccine makers have said they are studying their vaccines in young people as well.

Health

Congress alleges govt procuring Covid vaccine at inflated prices

The Congress leader said the price of such a vaccine must be cheaper than AstraZeneca-Serum Institute of India’s Covishield.

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New Delhi, Jan 17 : The Congress on Sunday questioned the procurement of Covid vaccines, alleging that the government has procured the vaccines at inflated prices despite the manufacturers claiming they would supply the vaccines without seeking profit.

Congress General Secretary Randeep Singh Surjewala, addressing a press conference, said, “Why should the Modi government pay Rs 95 per dose more to Bharat Biotech for a vaccine that has been developed with the expertise and experience of scientists of government-run ICMR and pay more for a vaccine that has only been tested on 755 individuals and is yet to be cleared after phase-3 trials?”

The Congress leader said the price of such a vaccine must be cheaper than AstraZeneca-Serum Institute of India’s Covishield.

“Why is the price of the vaccine at Rs 1,000 per dose in the open market?” he asked.

Surjewala said, “‘Covishield’ is an AstraZeneca vaccine manufactured by Serum Institute of India. Serum Institute is supplying this vaccine at Rs 200/dose to government. AstraZeneca has committed to supplying the vaccine at no profit while ‘Covaxin’, manufactured by Bharat Biotech, is being supplied at Rs 295/dose. Admittedly, Covaxin has been developed by Bharat Biotech in partnership with Indian Council of Medical Research (ICMR).”

SII CEO Adar Poonawalla had said stated that his company will sell Covishield for Rs 1,000 per dose in open market, that is Rs 2,000 for 2 doses required for every individual.

Surjewala said, “Why should export of vaccine be permitted without immunisation of India’s population? ‘Corona Vaccine For All’ should be the stated policy of Modi government.”

“However, the government’s approach on free vaccination or cost of vaccination, cost to exchequer, profit margins of companies, etc, for India’s 130 crore people is completely opaque and shrouded in secrecy,” he said.

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Health

13 Israelis suffer facial paralysis post inoculation

“For at least 28 hours, I walked around with it (facial paralysis),” one person who had the side effect told Ynet.

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Jerusalem, Jan 17 : At least 13 Israelis suffered mild facial paralysis as a side effect after receiving the first Covid vaccine jabs, the Health Ministry said, adding that the count could be higher.

The officials have raised questions on whether or not to administer the second dose to these individuals the Health Ministry had recommended for the second dose, reported the Jerusalem Post.

“For at least 28 hours, I walked around with it (facial paralysis),” one person who had the side effect told Ynet.

“I can’t say it was completely gone afterwards, but other than that I had no other pains, except a minor pain where the injection was, but there was nothing beyond that.”

As for receiving the second dose, he admits he is undecided, but says that “it is important to note that this is something rare, and I don’t want people to avoid getting vaccinated – it’s important”.

“I recently came across, for example, someone vaccinated who was dealing with paralysis, and decided not to give her a second dose,” Galia Rahav, Director of the Infectious Diseases Unit at Sheba Medical Centre told Ynet.

“It is true that it can be given according to the Health Ministry, but I did not feel comfortable with it.”

She added that, “No one knows if this is connected to the vaccine or not. That’s why I would refrain from giving a second dose to someone who suffered from paralysis after the first dose.”

However, the Health Ministry has assured of the second dose only when the paralysis passes, Ynet reported.

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Cities

Delhi reports 51 cases of minor adverse events post vaccination

As many as 1,91,181 people were vaccinated on day one of India’s first phase of the coronavirus vaccination drive.

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Hours after the Health Ministry announced on January 16 that India has reported no case of post-vaccination hospitalisation yet, 51 persons complained of minor adverse events in Delhi. Another person developed severe adverse event following immunization and had to be referred to the AEFI centre.

Out of a total of 4,319 healthcare and frontline workers who were vaccinated on Jnauary 16 in the National Capital, two healthcare workers at NDMC’s Charak Palika Hospital reported mild adverse event post-vaccination including mild tightness in the chest. They were kept under observation by AEFI team and discharged 30 minutes later after they felt at ease. The two other cases were reported from Northern Railway Central Hospital, of which one was referred to the AEFI centre, the Delhi government has informed.

As many as 1,91,181 people were vaccinated on day one of India’s first phase of the coronavirus vaccination drive.

Beneficiaries from 11 states and union territories across India received Covishield or Covaxin shots on the first day of the vaccination drive, namely, Assam, Bihar, Delhi, Haryana, Karnataka, Maharashtra, Odisha, Rajasthan, Tamil Nadu, Telangana, and Uttar Pradesh.

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