Pandemic related news in brief (including vaccines, drugs, trials, side effects etc.)

14 January
WHO recommends baricitinib and sotrovimab to treat certain COVID-19 patient groups

WHO’s Guideline Development Group (GDG) found evidence of moderate certainty that baricitinib (a Janus kinase (JAK) inhibitor ) improved survival and reduced the need for ventilation, with no observed increase in adverse effects and strongly recommends it for patients with severe or critical covid-19 in combination with corticosteroids.

As Baricitinib has similar effects to interleukin 6 inhibitors, when both drugs are available, the WHO GDG suggests choosing one on the basis of cost, availability, and clinician experience. It does not recommend using both drugs at the same time.

The WHO group has also made a conditional recommendation for the use of the monoclonal antibody sotrovimab in patients with non-severe covid-19, but only in those at highest risk of hospital admission, reflecting fewer benefits in those at lower risk.

Source: BMJ website

13 January 2022
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 –

Included in the above meetig were the ollowing two items:

Vaxzevria and COVID-19 Vaccine Janssen: update on very rare cases of transverse myelitis

The PRAC has recommended a change to the product information for Vaxzevria and COVID-19 Vaccine Janssen to include a warning to raise awareness among healthcare professionals and people receiving the vaccines of very rare cases of transverse myelitis (TM) reported following vaccination. TM has also been added as an adverse reaction of unknown frequency.

TM is a rare neurological condition characterised by an inflammation of one or both sides of the spinal cord. It can cause weakness in the arms or legs, sensory symptoms (such as tingling, numbness, pain or loss of pain sensation) or problems with bladder or bowel function.

EMA will continue to closely monitor this issue and will communicate further if new information becomes available.

Vaxzevria: fewer cases of thrombosis with thrombocytopenia reported after second dose

The PRAC has recommended updating the product information for Vaxzevria to add more information about the very rare cases of thrombosis with thrombocytopenia (TTS) that occurred following vaccination.

A review of cumulative data has highlighted that the majority of suspected TTS events were reported worldwide after the administration of the first dose. Fewer events have been observed after the second dose. In fact, out of 1,809 thromboembolic events with thrombocytopenia reported worldwide, 1,643 were reported after the first dose and 166 after the second dose.

As per the current product information, the administration of a second dose of Vaxzevria is contraindicated in people who have experienced TTS following vaccination with this vaccine.

Source: European Medicines Agency

11 January
Press briefing on EMA’s COVID-19 activities

Here is a link to the press briefing of 11 January on EMA’s COVID-19 activities .

EMA statement on the effectiveness of COVID-19 vaccines against the Omicron variant

The European Medicines Agency (EMA) has released a statement on the effectiveness of COVID-19 vaccines against the Omicron variant. Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant.

Source: EMA website

Status of administered COVID-19 doses across the globe

As of 11 January, 59.2% of the world population has received at least one dose of COVID-19 vaccine. 9.49 billion doses have been administered globally and 349 million are now administered each day.

Only 8.9% of the people in low-income countries have received at least one dose.

Source: ourworldindata

COVID-19 vaccines approved and in clinical trials globally

This site (link below) provides some very basic but useful information on the global progress with clinical trials for vaccines for COVID-19. You can also view information on vaccine approvals (this can be an emergency use authorisation or a conditional marketing authorisation but not a full approval) by country.

As of 7 January, the situation is as follows:

  • No of vaccines in Phase I trials = 41
  • No of vaccines in Phase II trials = 58
  • No of vaccines in Phase III trials = 63
  • No of approved vaccines = 32

More information on the regulatory status of vaccines or medicines is available here and here.

Source: covid19trackvaccines.org

8 January
Cypriot researcher discovers delta/omicron combination variant

Leondios Kostrikis, professor of biological sciences at the University of Cyprus has discovered a strain of the coronavirus that combines the delta and omicron variant. He called the strain “deltacron,” because of its omicron-like genetic signatures within the delta genomes.

So far, Kostrikis and his team have found 25 cases of the virus, according to the report. It’s still too early to tell whether there are more cases of the strain or what impacts it could have.

“We will see in the future if this strain is more pathological or more contagious or if it will prevail” against the two dominant strains, delta and omicron, Kostrikis said in an interview with Sigma TV Friday. He believes omicron will also overtake deltacron, he added.

Source: CNBC news

Update on 9 Jan: Global experts are casting doubts over reports of a new possible Covid strain appearing to combine both the delta and omicron variants and dubbed “deltacron.” They have said it’s more likely to be the result of a lab processing error.

Source: CNBC News

7 January
Judge orders FDA to hasten release of Pfizer vaccine docs

A federal judge in Texas ordered the FDA to make public, the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months.

That is roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine.

The FDA didn’t dispute it had an obligation to make the information public but argued that its short-staffed FOIA office only had the bandwidth to review and release 500 pages a month.

Rather than producing 500 pages a month — the FDA’s proposed timeline — the judge ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097.

Source: Reuters

Healthcare services in trouble in the US

Omicron is inundating a health-care system that was already buckling under the cumulative toll of every previous surge.

In this surge, COVID-19 hospitalisations rose slowly at first, from about 40,000 nationally in early November to 65,000 on Christmas day. But with the super-transmissible Delta variant joined by the even-more-transmissible Omicron, the hospitalisation count has shot up to 110,000 in the two weeks since then.

COVID will be sending at least 24,700 and up to 53,700 Americans to the hospital every single day.

Source: The Atlantic

Comment:

A stark reminder (if one is needed at all) of the severe impact of the Omicron variant on healthcare staff and services in hospitals across the US. This, in arguably one of the worlds most well funded healthcare sysytems. It seems not unreasonable to think that what is happening in American hospitals is likely being replicated to a greater or lesser extent across hospitals in the developed world.

One shudders to think how less well-to-do and poorer countries in the developing world might be coping (or not ) with the impact of Omicron, in the absence of properly funded or developed healthcare systems and the scarcity of vaccinations.

6 January
WHO COVID-19 media briefing

Here is a link to the media briefing on COVID-19 from the WHO held earlier today. You can read the Director-General’s opening remarks here. The full transcript of the briefing is available here.

5 January
Israeli firm develops test that can detect COVID-19 form saliva in under a minute

Israeli firm Kidod Scence and Technology Ltd. has developed a 50-second Covid-19 test that has been designed for use in schools, airports and at entertainment events

The portable testing device with the approximate the size of a desktop-computer, is able to detect Covid infected particles in saliva samples in under a minute, according to creator Kidod.

The firm claims it can provide results comparable to a PCR test. An application has been submitted to the UK MHRA and that it could be approved within weeks.

The Virion Test can detect Covid-19 using a saliva sample. The entire testing process, from taking the sample to getting the result, takes less than one minute.

The firm estimates it can process around 50 results an hour, which does not seem all that fast but it is significantly faster than lateral flow tests which take around half an hour for results and a PCR test which takes 24 hours or longer.

The testing device detects chemical compositions that reveal infection from the virus.

It is different from the technology for PCR tests, which looks for genetic material of Covid-19 or lateral flow tests, which detects specific viral proteins present inside your nose and throat.

The Virion Test detects biomarkers – characteristics that indicate certain biological processes – that Covid-19 releases within a person’s cells when it replicates. Moshe Golan, President of Kidod Science and Technology claims that this makes the results more accurate than other tests.

Source: i News

4 January
Israeli study finds fourth COVID-19 vaccine dose boosts antibodies five-fold

A fourth dose of COVID-19 vaccine boosts antibodies five-fold a week after the shot is administered, according the the Israeli PM, citing preliminary findings of an Israeli study.

Israel has played a leading role in studying the effects of COVID-19 vaccines, as the fastest country to roll out two-dose inoculations to a wide population a year ago and one of the first to give third shots as boosters. It is now administering fourth doses of the Pfizer/BioNTech vaccine to people over 60, health workers and immunocompromised patients.

Source: Reuters

3 January
Mike Ryan of the WHO on Covid, vaccines, and mistakes that were made

STAT news interviewed Mike Ryan, head of the health emergencies program at the World Health Organisation, for some insight about where we’ve been and where we’re heading. Dr Ryan and his team have worked flat out since late 2019, to help the world navigate the worst pandemic in a century. 

Source: STAT news

28 December
Vaccine skin patch under development at Lancaster university, UK

Scientists at Lancaster university (UK) are developing a Covid-19 vaccine skin patch.

Although the vaccine patches are at an early stage of development, if trials prove their success, they will dramatically change the Covid-19 immunisation process as people can receive them in the post and “vaccinate themselves” by simply sticking it on their skin, without having to queue at a facility to have a jab administere

24 December
Booster omicron protection wanes within 10 weeks

The protection conferred by booster vaccines against the omicron variant begins to wane within 10 weeks, according to a briefing released by the UK Health Security Agency (UKHSA).

Based on an analysis of 147,597 delta and 68,489 omicron cases, the agency found that the Oxford/AstraZeneca, Pfizer/BioNTech and Moderna vaccines are less effective against omicron than delta.

For people who had two initial doses of the Oxford/AstraZeneca vaccine, the UKHSA estimates that Pfizer/BioNTech or Moderna boosters are around 60 per cent effective at preventing symptomatic infections from omicron 2 to 4 weeks after the third dose, but this falls to 35 to 45 per cent by 10 weeks. For those who had two initial doses of Pfizer/BioNTech, protection falls from 70 per cent at 2 to 4 weeks to 45 per cent at 10 weeks after a Pfizer booster, but stays around 70 to 75 per cent up to 9 weeks after a Moderna booster. These results are summarised in the table below.

Initial vaccination and booster doseDose effectiveness at preventing symptomatic infections from
omicron after booster dose
Two initial doses Oxford/AstraZeneca vaccine followed by Pfizer/BioNTech or Moderna boosters 60% , 2-4 weeks
35-45%, by 10 weeks
Two initial doses of Pfizer/BioNTech
followed by Pfizer/BioNTech booster
70%, at 2-4 weeks
45%, by 10 weeks
Two initial doses of Pfizer/BioNTech
followed by Moderna booster
70-75%, up to 9 weeks after dose

Source: New Scientist

23 December
ASPR and FDA release joint statement on how SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies and its impact on several products granted Emergency Use Authorisations

Today, the Assistant Secretary for Preparedness and Response (ASPR) and the FDA released a joint statement on the circulating SARS-CoV-2 viral variants, including Omicron, and how the variants may be associated with resistance to monoclonal antibodies.

  • Data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant.
  • Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron variant.
  • FDA updated the Health Care Provider Fact Sheets for bamlanivimab and etesevimab administered togetherREGEN-COV (casirivimab and imdevimab), and sotrovimab with specific information regarding expected activity against the Omicron variant (B.1.1.529/BA.1).
  • Based on this information, ASPR will pause any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC.

Source: FDA website


Image by Alexandra_Koch from Pixabay